Pharma Impurity Conclave 2023

Friday, July 28, 2023

Pharma Impurity Conclave 2023: Dedicated to solving the stubborn challenges

A fresh dawn emerges, revealing another intriguing program, but the familiar and persistent challenge remains steadfast. In response to the urgent concern plaguing the pharmaceutical industry, Eminence Business Media takes immense pride in announcing the highly anticipated Pharma Impurity Conclave 2023, a symposium dedicated to solving the stubborn challenges by complying with the esteemed pharma fraternity, on the 7th and 8th of September.

While the exhaustive evolution of medicines has led to remarkable breakthroughs, the R&D journey has also encountered numerous challenges, particularly concerning drug impurities. With the advent of various discoveries and synthesis processes, various contaminants have been observed in drug formulations, presenting an array of complex challenges and disputes. However, driven by unwavering determination, the resolute pharma industry has confronted this diversity with remarkable efficiency and precision. Nevertheless, 2018 had a new obstacle in store - NITROSAMINES, which remains the most prominent concern for the industry.

Pharma Impurity Conclave 2023 aspires to surmount the most widely discussed challenges with unwavering efficacy, offering concrete solutions through in-depth exploration of the various layers of obstacles, thereby fortifying drug impurity profiling practices by evaluating their sources and processes. Though industry professionals are already familiar with multiple mechanisms of identification and risk assessment, the missing piece of the puzzle lies in quantifying uncertainty.

From delving into practical case studies to comprehending the latest guideline updates, this meticulously curated program is designed to address the most recent and pressing challenges concerning impurity mechanisms, adopting cutting-edge and distinctive learning tools. Attendees will have the unique opportunity to learn from distinguished experts and apply their theoretical hypotheses in the stimulating Pharma Impurity Conclave 2023 setting.

Thus, a new day brings forth another captivating program, wherein the timeless challenge is met with a fresh perspective and innovative approach, promising novel insights and solutions.

WHY ATTEND?

1. Interact with your peers and experts and learn about the different mechanisms.
2. Case study & live example-based sessions followed by group exercises.
3. Dedicated Q&A rounds followed by each session to solve all queries and doubts.
4. Benefit from the 6-month support of continuous learning.
5. Carefully designed interactive sessions with apt learning tools to enhance holistic mindset.
6. Networking activities to engage with like-minded individuals and industry leaders.

WHO CAN ATTEND?

From Managing Directors, Presidents, Vice Presidents to Sr. GMs, GMs and Mid-level management members, everyone can reap the benefits of this platform to learn and network with industry peers.

DEPARTMENTS

1. R&D
2. Analytical R&D
3. Quality Teams
4. Regulatory Teams
5. Manufacturing Teams

Hemlock Printers propels its customers forward with an HP Indigo 100K Digital Press


One of the largest and most recognized printing companies in North America, Hemlock Printers, enhances its digital print capabilities, automates processes, and ensures high-quality prints for its customers with the HP Indigo 100K Digital Press. With this investment, the company has been able to transform its product offering and improve productivity across the entire business.

Based in Burnaby, Canada, Hemlock Printers is diligently focused on being the industry’s most innovative and sustainable print provider, servicing a diverse range of customers and industries. The company has a long history of investing in advanced printing technologies which provide exceptional product quality, streamlined workflows and productivity improvements. The HP Indigo 100K Digital Press delivers on these benefits, strengthening Hemlock’s product portfolio and customer value-proposition in the process.

Hemlock Printers was founded in 1968 and has since operated as a progressive, family-owned business that prioritizes customer value, technological innovation, and sustainable leadership. Fifty-five years later, this remains true, with the company’s passion for continuous innovation and technological advancement a key component to their success.

With the addition of the HP Indigo 100K Digital Press, which is manufactured carbon neutral, the company has been able to build upon its environmental initiatives. Most notably, the Indigo 100K Digital Press contributes to Hemlock’s waste reduction efforts thanks to the material efficiency of the technology. Significant reductions in makeready and run waste, commonly greater than 90%, result in an efficiently produced finished product with a lower environmental footprint.

When discussing this latest addition, Richard Kouwenhoven, President & CEO of Hemlock Printers said: “The Indigo 100K is a very exciting addition to our pressroom enabling us to efficiently produce short run projects at an extremely high-quality level with the same range of paper options and product formats our clients are accustomed to. It is a versatile machine that really suits our business and will open new workflow automation opportunities for us in the future.”

Furthermore, Rob Baker, Director of Manufacturing at Hemlock emphasized, “The HP Indigo 100K Digital Press has also created new job opportunities for our employees. Skilled offset press operators have made the switch to operating the 100K Digital Press, expanding their roles since the installation. Knowing we can streamline tasks and allow our employees to grow at the company with the implementation of these products is truly invaluable.”

Hemlock Printers showcases how powerful digital print technology can be to modernize processes, propel business growth and opportunity, and meet the growing demand of printing services. 

Thursday, July 27, 2023

ERP Solutions for Small & Medium Engineering from SourcePro Infotech

Following ever increasing customer needs and the current volatile situations there are plethora of other challenges you might be going through in your business processes. At SourcePro Infotech, we are addressing these challenges of Business Enterprises like yours. Over last 20 years our ERP product has undergone multiple technological and functional evolutions, and that journey has now culminated into new version as “New Horizon. It is a state-of-the-art cloud-enabled ERP product. New Horizion is now accessible anywhere on any OS, on any device and at any time. Our New Horizon ERP takes away all the manual hassle and enables you to focus on your company goals.

SourcePro is a synergised team of highly skilled industry experts with the aim of optimising businesses through advanced ERP software products. Our customer-focused approach and commitment to innovation have kept us going strong for the past 28 years, and has raised the bar for software solutions across the industry. As technology advances at a rapid pace, we have developed a foresight that ensures that our products and services are future-ready and on the cutting edge.

With technical expertise coupled with a strong understanding of business, we have pushed the envelope to create ERP products that seamlessly integrate with your existing processes. That is what makes us one of the top ERP software companies in India—one that has been expanding value for businesses across a wide range of industries for over two decades.

In addition to Indian businesses, MNCs and joint ventures hailing from America, Australia, Germany, and Switzerland rely on SourcePro’s innovative, efficient, and robust software for their Indian operations.

Daco Solutions launches inspection slitter rewinder at Labelexpo Europe 2023 – Stand 4A53

UK converting equipment manufacturer Daco Solutions will launch its SRV350 inspection slitter rewinder at Labelexpo Europe 2023.  The servo-driven machine features an inspection system from Nikka, closed-loop unwind tension control, and a fully automatic slitting unit with servo-driven positioning of the knives. It runs at speeds of up to 300m/min with a 350mm web width and 800mm unwind diameter. An optional accumulator can be added, so any labels replaced on the web will pass back underneath the camera to ensure 100 percent inspection. 

‘This is our highest-specification machine in our slitter rewinder portfolio,’ said Daco’s sales manager Mark Laurence. ‘We have had great success over the years with our more economical models, but we were keen to expand our product range and be able to offer high quality equipment to even the biggest label converters. Adding an inspection system greatly reduces waste and guarantees a high-quality output. A version of the machine with a three-spindle semi-automatic turret, the PLR-V model, is already available and has sold steadily over recent years.’ 

Also on display in Brussels will be Daco’s PLD350 semi-automatic turret rewinder for plain label production and a PLR430 semi-automatic turret rewinder for slitting with integrated 1m unwind with roll lift. Daco Solutions, which has installed equipment in 56 countries around the world, has exhibited at every Labelexpo Europe show since the company’s foundation in 2001.

Monday, July 10, 2023

Pharma Regulatory Conclave 2023: The Unique Inaugural Program Taking Bold Steps!

The Inaugural Regulatory Program of Eminence Business Media, Pharma Regulatory Conclave 2023 set a very high benchmark for conferences based off learning and rejuvenation. The program was designed with a unique framework with one day virtual day program on 30th June and a two-day in-person conference at Hilton Resort, North Goa on July 5th - 6th. With the unique theme on the Day 2, “Patrao”, having dedicated Q/A rounds after every session, case study solving exercises, within the quaint locality in Goa amidst the monsoon, this regulatory program took a very distinctive and bold step by not only addressing current challenges of the pharma regulatory industry but also acknowledging the unaddressed yet crucial focus of emerging markets.

The virtual day was designed to give theoretical understanding to the delegates about the various required regulatory processes like Regulatory Intelligence, Dossier Filings and GDUFA III guidelines delivered by Mr Prafulla Nandi from Cadila Pharma, Ms Minoo Biju from Piramal Pharma Solutions and Mr Adam Freeman from exFDA Consultants. The program also included a very interesting panel discussion of international experts from regulatory bodies of USA, South Africa, and Latin America. Mr. Larry Stevens from USFDA, Ms Emtia Perold from SAPHARA and Mr Ivan Calderón from COFEPRIS shared their experience and gave insights about the practicality of having a common dossier for emerging markets. Pharma Industry veterans like Dr Udaykumar Rakibe from PharmaMantraTM and Dr Sanjit Singh Lamba from Biocuris Pharma were also a part of the discussion and presented the Indian Pharma perspective with their standing within the global market.

The unique design of the program facilitated Eminence Business Media’s commitment to delivering excellence by learning. The virtual program was corroborated with the in-person conference with a unique case study solving exercise which focused on emerging markets regulatory requirements. The session was designed by Mr. Rajeev Mathur from Sun Pharma and was facilitated by Mr. Udaykumar Rakibe and Mr. Rahul Jain at the in-person conference.

Delegates and attendees were working in groups and solving the case study for over a week to present their solutions with the groups on Day 2 of the conference. The group exercise was fruitful with unique frameworks being presented by the delegates as a solution to the cases. The two day in-person conference further thoroughly discussed topics like regulatory requirements of complex generics, drug approvals in ICH countries, life cycle management of a drug, post approval changes, among others. Experts like Mr. Rahul Gupta from USV, Ms Meenakshi Jain from Sandoz, Ms Adity Sen Pal from Indoco Remedies and Ms Vandana Singh from Biocon delivered the crucial topics and interacted with the audience by accommodating their questions. Mr Arani Chatterjee from Cadila Pharma and Mr Praveen Cherukupalli from Innovare Labs discussed the clinical trial regulatory requirements and the nitrosamine requirements which are the pain points for the industry. The in-person conference also witnessed a panel discussion on the ever-evolving challenges of regulatory affairs moderated by Dr Sanjit Singh Lamba. The expert consisted of panel members like Dr Mayur Parmar from Govt of Gujarat, Dr Venkat R Naidu from Dr. Reddy’s Laboratories, Ms Adity Sen Pal, and Mr Rahul Gupta.

Having understood the unique requirements of the regulatory professionals to clarify their doubts and addresses their questions, the program accommodated a panel of experts namely, Mr Prafulla Nandi, Mr Arani Chatterjee and Mr Praveen Cherukupalli to solely address the queries of the delegates and attendees. The in-person conference also had sessions catering to gap mitigation between regulatory and other departments by having a dedicated session on soft skills delivered by Mr Sushil Barkur. Further, the rejuvenating activity of the program was also designed with the underline learning of importance of working in collaboration focusing more on regulatory professionals being facilitators than inspectors.

Eminence Business Media plans to announce the dates for the fourth edition of the Computer Software Assurance in 2024, so stay tuned for updates on their LinkedIn page and event website.

Friday, June 30, 2023

EBM announces 3rd Annual Cleaning Validation 2023- A Practical Approach

Cleaning validation is an essential process in the pharmaceutical industry that ensures that all equipment used in the manufacturing process is cleaned to prevent cross-contamination and ensure product quality. Eminence Business Media acknowledges the need of focused training on the main pillars of an effective master cleaning validation plan and introducing a program that covers elaborated discussions and case studies for cleaning cycle, cleaning chemistry, regulated equipment, test limits and periodic monitoring; and announcing 3rd Annual Cleaning Validation 2023- A Practical Approach, scheduled for August 24th – 25th, followed by a virtual session on September 2nd. This program offers 2-day learning followed by 1 day follow up virtual session, this way the attendees can implement the 2-day learning in their professional lives and come back with follow up questions during scheduled virtual training.

From the insightful discussions and interactions between the eminent speakers and attendees we have ensured the entire training program would be very communicative. We at Eminence Business Media believe that learning should not stop only by brush ups or doubt solving, it should be evaluated by Case studies. Hence, after deliberating with experts with immense experience in the industry, we have drafted important subject of Cleaning Validation with practical learning.

WHY ATTEND?

  • Analyse the best of recent trends and advanced innovations for more efficient Cleaning Validation. 
  • Learn the practical approach with case study discussions and live examples.
  • Discuss your queries at the live Q & A sessions and reap the benefits from the extended 6-month support for continuous learning even after the event.
  • Take advantage of follow-up virtual session to address real time challenges after implementing 2 day in-person learning.
  • Share the dais with the industry leaders and network with your peers to understand what they do differently to be successful.

WHO WOULD ATTEND?
QA/QC: To ensure products meet the required quality standards and comply with regulatory requirements

Manufacturing & Production: To ensure equipment is properly cleaned and that the manufacturing process is not compromised by cross-contamination.

Regulatory Affairs: To ensure company complies with regulatory requirements for Cleaning Validation as well, amongst other processes.

Engineering and Maintenance: To ensure the maintenance and repair of the equipment used in the manufacturing process.

Analytical and R&D: To develop and validate analytical methods used in the cleaning validation process.

Saturday, June 24, 2023

Pharma industry strengthening the CSV & CSA approach with the 3rd Annual Computer Software Assurance 2023

The Pharma Computer Software Assurance 2023 conference’s third edition set remarkably high session originality and creativity standards, providing attendees with an engaging program full of valuable learning opportunities. This two-day in-person event occurred at Novotel Mumbai, Juhu Beach, on June 22nd and 23rd, 2023. The conference’s unique program design achieved a balance between CSV and CSA.

The conference commenced with a Keynote address from Eminence Business Media’s Managing Director, Ms Guneet Kaur Hayer. Her warm welcome set the expectations for the exceptional two-day learning program. The program began with an insightful Panel Discussion moderated by Mr. Ken Shitamoto, titled CSV or CSA. Esteemed panellists included Mr. Francisco Vicenty from USFDA, Dr. Mayur Parmar from Govt of Gujarat, Mr. Ravi Kalla from Anthem Biosciences, and Mr. Sanjeev Dharwadkar from Pharma Tech Consulting. This session explored various aspects of CSA and CSV approaches in the pharmaceutical industry, providing valuable insights from a regulatory as well as manufacturing perspective.

Following the panel discussion, attendees had the opportunity to engage in a Fireside Chat with Mr. Francisco Vicenty, enabling direct interaction and the chance to ask questions to the FDA. The day continued with a session delivered by Ms. Deepa Pangaonkar from Wockhardt, focusing on the challenging topic of ‘Quality Testing and Evidence’ within CSA & CSV. Mr. Vivek Bansal from Biological E. then led an engaging session on ‘Change Control and Change Management,’ an essential topic for understanding the transition from CSV to CSA. During the conference, partners such as Persistent Systems, Techsol Life Sciences, RxCloud, Rephine, and Conval Group had the opportunity to participate in a unique networking session. Additionally, Mr Ravi Kalla designed a process activity for the delegates, promoting collaboration and emphasizing the importance of unified systems.

The second day of the conference commenced with an intriguing session on Digital Validation Systems by Mr Khaled Moussally from Compliance Group. This session highlighted the significance of going paperless and explored various platforms offering practical solutions. Subsequent sessions focused on facilitating the transition from CSV to CSA. Mr Ken Shitamoto delivered a vital talk on Critical Thinking, followed by Mr Pranav Gadre from Reliance Life Sciences, sharing his experiences working in IT and QA teams. The latter half of the day concentrated on topics such as Industry 4.0 and Data Integrity Risk Assessment (DIRA) designed by Mr Rajesh Thempadiyil from Dr. Reddy’s Laboratories through a group exercise that stimulated intense discussions and generated vital takeaways.

True to the distinctive nature of the Eminence Conference, the program concluded with a unique

and invigorating activity designed to encourage delegates to ask questions in a rapid-fire fashion. The representatives debunked over 100 myths in an impressive feat within 45 minutes. The day concluded with a unique networking activity, where delegates and speakers could bond over cold beers and 360° Cam experiences.

Eminence Business Media plans to announce the dates for the fourth edition of the Computer Software Assurance in 2024, so stay tuned for updates on their LinkedIn page and event website.

Wednesday, June 7, 2023

IntraPac India Moves to India Expo Centre, Greater Noida, NCR Delhi

The Indian Printing Packaging & Allied Machinery Manufacturers' Association (IPAMA) announces a venue change for the upcoming IntraPac India exhibition. Due to the unavoidable circumstances and some technical reasons, IPAMA has decided to shift the event to India Expo Centre, Greater Noida, NCR Delhi. 

IntraPac India, an exclusive exhibition focused on the Packaging Industry, will now take place at India Expo Centre from 14th to 17th March 2024. This premier event will showcase a wide range of packaging solutions, machinery, and allied products, including plastic packaging, metal packaging, glass packaging, paper packaging, filling, capping, sealing, biodegradable packaging, protective packaging, automation and robotics, tube packaging, mono cartons, pharmaceutical packaging, traceability & tracking, logistics, film, moulding, and many more. 

In light of the venue change, IPAMA has revised its rates and is offering exhibitor spaces at a highly economical price to packaging companies. This move aims to encourage participation from a larger number of MSME Units in the Exhibition. The rates for subsequent editions will also be reviewed and adjusted to ensure greater affordability. 

IPAMA has reserved four halls, covering a total area of 14,000 square meters, at India Expo Centre. Within just one month of the exhibition announcement, 48 companies have already confirmed their participation and secured their spaces. 

To incentivize early registration, IPAMA has introduced an Early Bird Discount of Rs. 1000/- Per Sq. Mtr. The last date to avail of this discount is mentioned on the official website. Furthermore, exhibitors will also be eligible for a special motivational discount, subject to approval by IPAMA's governing council committee. Additionally, membership discounts will be provided based on the tenure of membership. 

IntraPac India at India Expo Centre promises to be an exceptional gathering of industry professionals, providing a platform to explore the latest trends, innovations, and business opportunities in the packaging sector. 

The Indian Printing Packaging & Allied Machinery Manufacturers' Association (IPAMA) is a leading industry association that represents the interests of the printing, packaging, and allied machinery manufacturers in India. IPAMA strives to promote growth, innovation, and collaboration within the industry through exhibitions, seminars, workshops, and other initiatives. 

EBM announces the Pharma Regulatory Conclave 2023 at Hilton, North Goa from 5th - 6th July, 2023

Complying to ever evolving global requirements of emerging markets and meeting regulatory expectations of a well evolved landscape is vital to maintain the safety & efficacy of the new & existing drugs, and accuracy of product information. Eminence Business Media acknowledges this need and after conducting several successful conferences, liked, and appreciated by the pharma fraternity, we are coming up with the inaugural program Pharma Regulatory Conclave 2023 in Hilton, Goa. 

This program will be a reference guide for identifying the challenges and underlying opportunities in the regulatory framework, for overall growth in aspects of essential documentation, preparing the dossier efficiently and filing the global application, followed by unparalleled business & research opportunities, networking platforms, and access to new trends in the Indian pharma world. 

At this forum, top issues highlighted by the regulators will be addressed by the pharma experts & key people from regulatory bodies, as they share their insights, experiences and use case studies on updated regulations & policies, maintaining data in the information system, ensuring compliance with regulations, and evaluating applicable laws to determine impact on company activities. 

This is your best opportunity to arrive and meet the biggest array of members from the regulatory and related departments. Network with your industry peers, discuss the new trends, strategies, and solutions, and meet the apt partners to take home the most relevant learning to help you grow and meet your company goals. Let's connect and together build the Pharma Regulatory Conclave 2023. 

WHY ATTEND?
1. Take advantage of the dedicated day 0 webinar a week prior to the in-person event, with extensive opportunities to clarify your doubts.
2. Discuss your queries during dedicated Q&A sessions and reap the benefit from the extended 6-month support for continuous learning.
3. Solve live case studies & deliberate on the shortcomings and practical solutions.
4. Network with the industry leaders to understand what they do differently to be successful.

WHO SHOULD ATTEND?
MD, Directors, CXO’s, President, Sr. VP’s, VP’s, GM’s, Heads, Leads, Managers and professionals from:
1. Regulatory Affairs
2. Regulatory Operations
3. Research & Development
4. Manufacturing & Supply Chain
5. Quality Teams
6. Academia
7. Everyone who needs to comply with regulatory guidelines, managing database, product information and filing dossier. 

For more information, log on to http://www.thepharmaregulatory.com/

Co-creation, collaboration, and commitment – a FESPA reflection by Axel Stuhlreiter

In these post Coronavirus times, all eyes turn to major industry events so we can try to draw conclusions about the prevailing mood and levels of confidence. Well, if this year’s FESPA Global Print Expo in Munich is a good barometer, we have cause for optimism. The appetite for meeting, greeting, and yes investing was palpable along the thronged aisles and stands.

On the Ricoh, textile-oriented, stand, the atmosphere was as upbeat as anywhere. Throughout the four days last week, there was a steady stream of visitors – textile creatives and other specialists, Print Service Providers, partners, journalists, and analysts keen on seeing for themselves how Ricoh’s offer to the garment printing industry is evolving through both Direct to Garment and Direct to Film solutions. 

We were delighted to demonstrate a range of solutions. Some established, some brand new, and welcomed all the constructive feedback. Co-creation is one of our guiding principles. It wasn’t just DTG and DTF though as there were many conversations about Ricoh’s inkjet print head expertise and how it could enhance manufacturers’ production capabilities. Our partners Fruit of the Loom and Russell Athletic made Ricoh’s booth a truly collaborative venture. 

It was very clear that these brands’ all-encompassing commitment to sustainable garment production echoed our own environmental philosophy. And that the partnership is founded firmly on shared values. 

Perhaps though what will live longest in memories will be our celebrated Manga artist, Uchida, painting, over the course of the show, a wonderful Manga scene. She attracted crowds of onlookers who watched the picture emerge on the three by two metre canvas. Many of them then chose an individualized printed T shirt with their preferred Manga design to take away as a memento. 

So, I and my Ricoh colleagues can now reflect fondly on a great experience at FESPA. It was successful for us but also of course very importantly, it worked for our industry too.

How mail delivers on sustainability

A white paper by By Sander Sondaal, Director Commercial Print Sales, Ricoh Graphic Communications, Ricoh Europe says that mail can be a sustainable choice. And by taking every opportunity to reduce the impact it makes throughout its lifecycle; it can contribute to a circular economy while playing an effective role in the marketing mix. 

That is according to the Royal Mail’s Marketreach which commissioned new research by environmental experts WSP to create a full carbon Life Cycle Assessment of Mail. 

It details the environmental impact and carbon emissions for each stage of mail from the forest to end of life including processing, design, production, delivery, and recycling. It quantifies the carbon emissions of some of the most commonly used mail formats. 

Delivery of mail is also considered. This is something the Royal Mail is hoping to address with the use of micro electric vehicles and drones for more remote locations. 

Other European postal service providers are also making strong progress in meeting their 2030 targets. By then Swiss Post is planning to be completely carbon neutral and Austria Post, which has the the largest fleet of electric vehicles in Austria, hopes to achieve 100% CO2-free delivery. 

The assessment by WSP also suggested the following ways to further manage carbon emissions:

  • Ensure paper is sourced from certified forests – Certified paper from a well-managed forest, where trees are felled and replanted, absorbs more carbon dioxide (CO2) than a mature forest. Forests represent a proven carbon capture and storage system.

  • Explore format size options – Weight, size, pagination, and type of paper matters. Smaller, simpler formats involve less processing, packaging and reduce carbon footprint when it comes to delivery. Impact can be made with short runs and personalised print featuring bold and creative designs. This is something Ricoh’s sheetfed colour digital printing presses can deliver with cost effective customised and individualised print as well as vibrant colour and metallic finishes using fifth toner technology.

  • Create accurate and engaging personalisation – Careful management of mailing lists reduces waste and gets results. Royal Mail figures show that 95% of mail is engaged with and 87% of recipients describe mail as believable. Maintaining accurate data is crucial to this and can be achieved with software such as /data.mill Data Cleansing Solution. It automatically interrogates and corrects data inaccuracies quickly and simply, aiding a smooth and effective process.

  • Careful design choice – Maximise circularity by caonsidering recycling and reuse. Use good imposition software that helps maximise substrate use to avoid excess waste while also reducing costs. Options include the easy-to-use FusionPro VDP Solutions suite of tools for simple design and production of personalised communications. 

Encourage end users to change their approaches too by helping your clients to become aware of the advantages of circularity. 

Also important is working with partners on the journey towards circularity. Together operations can make small steps towards big changes. This is where Ricoh can partner with you to identify what steps are possible and how best to take them.

Tuesday, June 6, 2023

Attend the 3rd Annual Computer Software Assurance 2023 to strengthen your CSV and Relook at the CSA Approach

Having organised two successful virtual editions, Eminence Business Media has thrived in addressing the most critical and crucial challenge areas of the Pharma Industry. Obeying the request of the pharma fraternity and living by the motto, "Learning is a constant process", to address the building apprehension and calm the nerves of the pharma industry, we are back with an exciting in-person edition. Eminence Business Media proudly announces the 3rd Annual Computer Software Assurance 2023, Live and In-stereo.

Computer System Validation (CSV) was adopted as a new technology by the pharma industry when technological advancements deterred the quality of systems. It has significantly ensured software quality and demonstrated that computer systems work as intended during inspections and audits. On the other hand, Computer Software Assurance (CSA) is said to be a futuristic mindset based on risk-based critical thinking. The logic promotes simple computerised onboarding with a unique operational context. 

The 3rd Annual Computer Software Assurance 2023 aims to strengthen and empower these systems. The idea is to create a program that explores the various elemental components to strengthen the CSV gameplan, address the challenge areas to boost the existing system and look at the futuristic mindset of CSA by analysing the knowledge gaps and bursting the myths. 

From meeting experts to learning from the regulators themselves, the program is designed to cover different aspects, addressing new challenges, presenting solutions & learning tools that deliver theoretical hypotheses and encourage practical application-based activities. 

BENEFITS OF ATTENDING
1. Interact with your peers and regulators concerning current guidelines.
2. Case study & live example-based sessions followed by group exercises.
3. Understand the CSA approach and strengthen your CSV.
4. Break the industry myths concerning CSA.
5. Dedicated Q&A rounds followed by each session.

KEY HIGHLIGHTS
1. Benefit from the 6-month support of continuous learning.
2. Carefully designed interactive and creative sessions to enhance holistic learning.
3. Networking activities to engage with like-minded individuals and industry leaders.
4. Upskill yourself to reap the desired results and overcome the challenges. 

DEPARTMENTS THAT CAN ATTEND
1. IT Quality Teams
2. CSV Teams
3. IT Compliance Teams
4. Corporate Quality Assurance Teams
5. Quality Assurance Teams 

DESIGNATIONS THAT CAN ATTEND
1. Managing Directors
2. Presidents
3. Vice Presidents
4. AVPs/VPs
5. Sr. General Managers, General Managers, Assistant General Managers
6. Team Leads

For more details, log on to https://pharmacsa.com

Monday, June 5, 2023

Novachrome Digital Design & Imaging expands existing Color-Logic license at no cost

In 2013, Novachrome Digital Design and Imaging, in the St. Louis suburb of Brentwood, Missouri, purchased Color-Logic software and began producing exciting metallic images on their FujiFilm Acuity and Canon Arizona large format presses. Recently, Novachrome purchased the new FujiFilm Prime large format engine. To increase Novachrome productivity and to broaden their ability to utilize Color-Logic for enhancing point-of-purchase, signage, packaging prototypes, and short run labels with metallic embellishments for their brand customers, Novachrome immediately submitted test forms from the new FujiFilm Prime for Color-Logic certification. According to Richard Ainge, Color-Logic Chief Technology Officer and developer of the Color-Logic System, “The printed test form sheets supplied by Novachrome indicated that their new FujiFilm Prime produces all Color-Logic embellishments and metallic colors in proper fashion.”

Commenting further upon the Novachrome installation, Color-Logic Director of Sales and Marketing Mark Geeves commented: "Unlike most print software today, Color-Logic provides licensees with a lifetime site license that enables Color-Logic clients to utilize our metallic embellishments and metallic color system on any device we support. When printers like Novachrome acquire new equipment--as Novachrome did with their new FufiFilm Prime--they can continue to enjoy the benefits of Color-Logic metallics and embellishments at no additional cost." 

Color-Logic develops color communication systems and software tool sets for a variety of special effect printing applications.  Color-Logic provides brand owners, product managers, corporations, and their advertising agencies the ability to differentiate themselves and their clients with a simple print production process that yields dramatic results. Color-Logic decorative effects utilize the existing workflows of printers and designers, yielding dynamic results without the use of special equipment. Color-Logic supports the value of print and works with designers and printers to enhance their printed media. For more information, visit www.color-logic.com

Thursday, May 4, 2023

Grand Success of the 6th Annual Pharma Project & Portfolio Management 2023: EBM does it yet again!


The 6th edition of the Pharma Project & Portfolio Management set very high benchmarks in the originality and creativity of the session and delivered an exciting program filled with learning and experiences. This three-day in-person conference was held at Fairfield by Marriott near the Mumbai International Airport from 26th to 28th April 2023. The program was designed uniquely by balancing the various discussion topics between the project and portfolio management teams. The conference started with the Keynote address from the Managing Director of Eminence Business Media, welcoming everyone and setting the expectations for the three-day unique learning program. The program's first session was taken by Mr Mike Teiler, Principal Consultant, Teiler Group, on Portfolio Strategy and Product Selection.

The session delivered the necessary implications for the project and portfolio management teams required to perform the auction session the next day. The first day of the conference mainly consisted of portfolio management topics where industry leaders like Dr Mukesh Kumar M.D., Mr Edward Coutinho, Dr Paras Vasanani and Mr Pradeep Patni covered issues related to Biosimilars, Pipeline Management and collaborative partnering process to manage the planning perspectives and uncertainties efficiently. The day also explored the nexus of IPR and Portfolio by discussing topics like competitive intelligence for portfolio designing led by Dr Mandar M Kodgule, Chairman and CEO of IQGEN-X Pharma. The day concluded with the delegates solving an exciting case study by Ms Tahseen Rana on the drug development process against the complication of the pandemic and timelines!

The second day of the conference had a different flavour attached to the day by introducing a theme to a conference day, Retro or Bollywood. The delegates dressed up in the styles of the 70s, 80s and 90s and flared their approach with Bollywood ideas. Filled with various group activities and eminent personalities as speakers, the retro theme was the cherry on the cake. The day majorly discussed crossover topics most creatively. Mr Sapan Parikh from Zydus Lifesciences led the issue of supply chain management and vendor selection with a skit performance on stage to showcase the different scenarios of department communications. Mr Nirav Shah followed the session with an exciting and much-required topic: Value leakage of life cycle products. The third session of the day was the much-awaited group activity of Auction, conducted by Mr Mike Teiler. The eight hypothetical companies in the room had to bid for the products on the platform, and the experience created was one-of-a-kind in the pharma world. The second half of the day discussed the various perspectives of the project management by discussing topics like a universe of the PMO by Mr Saifur Rahman and learning about the untapped potential of the Indian pharma industry by Mr Abhilash Soral from Indoco Remedies.

The third day of the conference purely discussed the Project Management topics, including setting up PMOs, discussing the relevant skills for handling biosimilars, emerging markets being the new pharma approach and looking at the old project management concepts from a new lens of evolving unique solutions. The sessions were conducted by Dr Laila Fatima, Mr Abhishek Mittal, Mr Debashis Sarkar and Mr Sivanandam Kesavan. The most refreshing session for Day 3 was conducted by Mr Sushil Barkur, who moderated a one-of-kind invigorating session on soft skills by conducting a session on Game Theory.

Eminence Business Media will soon be back with the dates for the 7th edition of the Pharma Project & Portfolio Management 2024. Stay tuned on LinkedIn page and event website for more updates!

Tuesday, February 14, 2023

Cosmo First expands new businesses while temporary inventory corrections impact specialty sales

Cosmo First Limited today declared its financial results for the quarter ended Dec 2022. During the quarter, BOPP and BOPET industry faced excess supply caused due to bunching of new production lines and on the other hand demand disruptions in overseas markets. The contribution margin dropped below sustainable levels and impacted everyone in the industry. The Company mitigated the impact on the back of its strong presence in specialty films segment. The performance could have been better but for:

  • One-time inventory loss in Raw materials and Finished Goods (both in India and subsidiaries)
  • Planned maintenance of some of the production lines
  • Restricted flow of orders for specialty films due to festive and holiday season in Europe and USA
  • Larger funding of operating deficit in the rapidly growing Petcare vertical.

The BOPET line which was commissioned towards the end of last quarter continued to focus on perfecting recipes, processes, and quality parameters for various specialty and value-added films in line with the company’s entry strategy in polyester films. 

The company’s petcare vertical is rapidly expanding and clocked monthly run rate of Rs. 1 crore in sales revenue from its 11 experience centers in various locations and increasing online presence through its website and mobile app. 

The company’s financials remain strong with annualized ROCE and ROE at 20% and 25% respectively and net debt to EBITDA of less than one time. 

In December 2022, the company announced the Buyback of its shares from all the shareholders via the tender route with an outlay of Rs.108 crores. The offer period ended on 9th February 2023 and the shareholders should receive payment by 20th February 2023 as scheduled. 

Commenting on the company’s performance Mr. Pankaj Poddar, Group CEO, Cosmo First Ltd. said “the near-term outlook for BOPP and Polyester films is expected to be challenging though the company’s strong speciality films portfolio should deliver superior returns. Zigly is rapidly becoming well known among pet parents benefitting all pet lovers and the company’s shareholders. Specialty chemicals division should double its net revenues while actively focussing on new product launches.”

Founded in 1981, Cosmo First today has a presence across 100+ countries around the globe. Cosmo First is a global leader in specialty films and an emerging player in specialty chemicals (Masterbatches, Adhesive, Coating & Textile chemicals) along with digital-first Omni channel Pet care business under the brand name ‘Zigly’.

Thursday, February 9, 2023

CII Awareness Session on Prevention of Sexual Harassment of Women at Work (POSH)

The Government of India has enacted The Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013 (“Act”). The Act requires every employer with 10 or more employees to constitute an Internal Complaints Committee (“IC”) that will deal with complaints regarding sexual harassment at the workplace.

Confederation of Indian Industry (CII) over the years has been committed towards Women Empowerment and works closely with industries to strengthen women’s role and participation in the economic sphere and community affairs. In the forum of empowering and strengthening women, our focus areas had always been, Gender equality at workplace; Prevention of sexual harassment at workplace and Women empowerment at the community level. Sexual Harassment at a workplace is considered violation of women right to equality, life and liberty. It creates an insecure and hostile work environment, which discourages women’s participation in work, thereby adversely affecting their social and economic empowerment and the goal of inclusive growth. 

Against this background, CII WUP is organizing Session on “Prevention of Sexual Harassment of Women at Work (POSH)” from 1500 – 1700 hrs on 3rd March 2023 at Virtual platform (Cisco Webex). Please note that the POSH Training once a year is mandatory for every organisation to keep in accordance with the law

This workshop is aimed at enabling participants to develop greater understanding of behaviours that maybe considered inappropriate at the workplace in context of Sexual Harassment and the impact of such behaviours. It will also help develop deeper understanding at the leadership level about the responsibilities, impact, and risks for the organization, as a result of behaviour and complaints relating to Sexual Harassment at the workplace. Building skills and enabling the leadership team to carry out its duties as per laid down procedure and follow the law in its true spirit. 

The workshop will focus on following key area:

  • The Scope and Applicability of the Sexual Harassment of Women at the Workplace (Prevention, Prohibition, Redressal) Act 2013.
  • What amounts to Sexual Harassment?
  • The importance of constituting an Internal Committee and its powers and responsibilities.
  • The redressal mechanism available under the Act.
  • Compliances required under the Act.          

The Faculty, Ms Raddhika Singh is a lawyer with over 16 years of experience and is the Managing Partner at Aletheiaa Legal a law firm she founded in August 2014. She is an Intellectual property & commercial lawyer and startup advisor. Ms Singh has worked with tier 1 law firms of India - Remfry & Sagar, K&S Partners, Luthra & Luthra. She has conducted trainings and workshops for over 8000 participants on matters pertaining to Intellectual property rights, Information Technology laws and Prevention of Sexual Harassment at Workplace and has advised over 350 start-ups on various legal compliances and policy requirements. She has done LLM in Intellectual Property Laws, Kings College London and University of London and LL.B from Delhi University.

NDigitec introduces benefits of Catena exposure technology to the Middle East


A new ThermoFlexX Catena-E 80 exposure unit from XSYS has allowed the UAE-headquartered company to elevate its plate-making capabilities to new heights. By integrating this innovative UV LED technology, NDigitec can now supply customers with higher-quality digital flexo plates and enjoy faster processing times than before, while reducing plate waste and energy consumption.

Namma Int’l Digitec FZ LLC – known as NDigitec – is a family-run business founded in 2005 in Dubai (UAE). As the industry leader in the MEA region in terms of production facilities, staff members, and square meter consumption, the prepress division of the company supplies a complete package of services – from file reparation to final processed flexo printing plate.

Employing a total of 125 staff across two branches in Dubai, a facility in Riyadh (Saudi Arabia), and an office in Yerevan (Armenia), NDigitec also offers digital printing solutions, e-commerce, creative media production, and fabrication of exhibition equipment. Some 500 customers in 25 countries avail themselves of the company’s many high-end competencies, which also include Online competencies: the DUBAIPRINT.COM web-to-print platform with solutions for the widest variety of print applications, and FLEXOEASY.COM, an unprecedented digital platform that makes flexographic plate-making easy and allows customers to access high-quality Prepress and Premedia services from anywhere in the world.

Plate innovation leader with big ambitions
NDigitec Prepress is known as an innovation trailblazer, always seeking out the latest plate-making technologies to stay ahead of developments and to deliver leading solutions to its global brand owner customers. Some 55% of the annual 50,000 sqm plate output is supplied to the flexible packaging industry, another 25% goes to the corrugated segment, while the remaining 20% is divided between folding cartons and labels.

“We were the first prepress company in the region to bring in LED exposure technology for making flexo plates with the Flint Group nyloflex® NExT system back in 2016,” said Shahe Kavlakian, Executive Manager for Prepress at NDigitec and brother of the company’s CEO Vatche Kavlakian, who as a pioneer of integrated prepress and printing services, laid the roots for the business in the early 1990s.

“Now we are once again taking the lead as the first to install the XSYS ThermoFlexX Catena-E system; an investment we have made because we believe that this solution will best support us in responding to the many varied customer demands we are currently facing and to allow us to continue our global expansion.”

Improving quality and reducing waste
Providing high-performance LED exposure for precise image reproduction, the ThermoFlexX Catena-E 80 is an open system that can process plates in sizes up to 1270 x 2032mm (50 x 80”) and all thicknesses for any type of flexo printing. With a very high level of automation, the unit can also be combined with a ThermoFlexX imager and Catena washer, dryer, and light finisher units for a full end-to-end plate production line, an option that NDigitec is closely evaluating as part of its future strategy. While the Catena-E 80 has been installed in Dubai, there are more immediate plans to upgrade the company’s exposure hardware across the other sites.

“The effect of the new Catena unit has been very noticeable,” said Shahe Kavlakian, who explained more about the team’s criteria in evaluating the technology. “We are looking for standardization, durability, efficiency, and stability in plate production; these aspects are key to maintaining productivity and quality. Particularly in flexible packaging, consistent solid ink density with perfect highlights is a challenge, but with the Catena system and our own micro surface screening, we can deliver results that are much better than with other LED solutions.”

Among the other immediate benefits enjoyed in Dubai was a reduction in waste compared to the existing system. “The Catena-E is definitely helping to improve the sustainability of our plate-making operation because we can combine different jobs on the same plate. By our latest estimations, plate waste has gone down from around 26% to 16%, and we know that with the latest LEDs in the machine, energy consumption will also be less. So, from an environmental point of view, as well as in terms of costs, this is a great improvement.”

Quick and effective implementation
With any new technology, there is inevitably a learning curve, but the near plug’n’play nature of the Catena system meant that the unit was in full production at NDigitec within a week. Mr. Kavlakian praised the simplicity of the design and the user interface, and in particular, highlighted the ability to access the unit controls remotely.

“The Catena is very easy to operate with straightforward instructions and options, so training was pretty quick. It also comes with remote capabilities which means that calibration and regular maintenance checks can be done without having anyone coming on-site. This is of course a fantastic feature as we can avoid unwanted downtime because we don’t have to wait for an engineer to attend in person,” he said.

Supporting future growth
Looking to the future, NDigitec has major plans to take more of the global market share. To further this goal, it opened a new state-of-the-art 50,000 sqm factory in Dubai Production City in 2020. Another 3,000 sqm facility operates as an incubator for joint venture projects aimed at advancing innovation in flexo print production, complemented by more investment in best-in-class imaging, processing, and screening technologies.

“In addition to the immediate benefits we have already experienced, the ThermoFlexX Catena-E 80 exposure technology will give us a stable platform to build our future plate-making infrastructure, stay competitive, and support our ambitious growth strategy,” concluded Shahe Kavlakian.

Register Now to Visit Pamex 2023 Mumbai

Friday, February 3, 2023

PrintWeek is celebrating the power of women with The Women to Watch in 2023

 PrintWeek is celebrating the power of women with The Women to Watch in 2023. The Women to Watch Awards are for outstanding women who lead, inspire, and motivate greatness in the printing and packaging community. As part of PrintWeek’s commitment to promote the advancement of diversity, inclusion, and equality in the printing industry, these awards, in their first ever year, celebrate the achievements of India’s business leaders, change makers, trailblazers, and rising stars.

We invite the industry (that is, you) to help us recognise the women who, over the last 12 months, have shown outstanding leadership and fostered groundbreaking innovation in the printing, packaging, research, and development, as well as the future leaders of tomorrow. Women may nominate themselves or any women, team and businesses that have inspired them and made an impact in the community.

We look forward to celebrating the achievements and championing the advancement of Women in 2023.



Wednesday, February 1, 2023

6th Annual Pharma Project & Portfolio Management 2023 awaits you


Eminence Business Media is proud to announce the 6th Annual Pharma Project & Portfolio Management 2023 to the most demanding and accountability-driven teams of the Pharma Industry! The success of the previous 5 editions of Pharma Project & Portfolio Management tempts EBM to, once again, proudly announce the 6th Annual Pharma Project & Portfolio Management 2023. It is the perfect one-stop destination to learn everything from dealing with the day-to-day complexities to developing a futuristic vision within the industry.

True to its essence and intention, this year's program has been designed in the most creative sought-after method that collates and captures the most relevant and essential discussion areas to promote conversations based on provocative thinking. The sessions have been planned to cater to and solve the existing head challenges by addressing the current skill gap and lack of competitors' knowledge and analysing the pharma trends about IP and finance. 

The forum comprises expertise-based creative sessions, live-case studies, dedicated Q&A rounds, hands-on soft skill learnings, and peer-led networking. Top-level management and pharma experts from project and portfolio management teams will share their insights and present solutions and strategies that help individuals meet their organisational goals. Join us at the 6th Annual Pharma Project & Portfolio Management 2023 and witness the most intriguing and niche topic discussions with the most unique problem-solving perspectives. 

WHY ATTEND?
1. Be a part of the one-of-a-kind Pharma Auction and learn concepts with real-time competition.
2. Learn Technical and Soft Skills by the application of Game Theory.
3. Solve Live-case studies and form practical solutions and frameworks.
4. Discuss and resolve queries with the dedicated Q&A session after every session.
5. Benefit from the 6-month support of continuous learning.
6. Carefully designed interactive and creative sessions to enhance holistic learning.
7. Multiple Networking Sessions.
8. Rejuvenating activities to enhance the learning potential.

WHO SHOULD ATTEND?
President, Managing Directors, CXOs, Sr. VPs, VPs, GMs, Sr. Managers, Managers and Professionals from :
1. Portfolio Management Teams
2. Project Management Teams
3. IP Teams
4. Finance Teams
5. Supply Chain Management Teams
6. Academia

“For the past five editions we have thrived on our unique event format and content. In the last couple of years, we have adopted innovative ways of working learned from them and realized their benefits. At Eminence Business Media we believe learning should not stop. Hence after deliberating with the experts with immense experience in the industry, we bring to you the 6th Annual Pharma Project & Portfolio Management 2023 Mumbai where we are focusing on the challenges and opportunities thrown at the Project and the Portfolio teams in the new normal. In this edition dig deeper into the innovative technologies like AI & ML that can be leveraged to enhance our decision-making. Envisioning the future let us discuss how hybrid working will help us perform better on our projects. With innovations also comes challenges and risks so let's discuss the solutions together. On this open platform let us come together and use this opportunity to meet each other learn from the experiences of our peers and grow together,” concludes Ravnish Juneja of EBM.

For more details, log on to http://www.pharmaprojectandportfolio.com/

Wednesday, January 18, 2023

3rd Annual Pharma GMP and Quality Management to be held on 16th & 17th March 2023

Following the highly successful 2nd Edition, Eminence Business Media is planning the 3rd Annual Pharma GMP & Quality Management 2023 in Mumbai. For the constantly evolving pharma industry, this program will offer help to identify opportunities for overall growth in aspects of Quality Management and Good Manufacturing Practices as well as Risk Management, followed by unparalleled business & research opportunities, networking platforms, and access to new trends in Indian Pharma Industry.

At this forum, top quality management issues highlighted by the regulators will be addressed by the pharma experts as they share their insights, and recent advancements in pharmaceutical sciences, manufacturing, quality control aspects ensuring that products are consistently produced and controlled according to highquality standards. This is your best opportunity to arrive and meet the biggest array of members from the GxP & Quality management groups. Network with your industry peers, discuss the new trends, strategies, and solutions, and meet the apt partners to take home the most relevant learning to help you grow and meet your company goals. Let's connect and together build the 3rd Annual GMP & Quality Management 2023.

Why Attend?
1. Solve live case studies & deliberate on the shortcomings and practical solutions.
2. Learn how the innovations in Quality Management are improving compliance with evolving regulations?
3. Discuss your queries at the live Q & A sessions and reap the benefit from the extended 6-month support for continuous learning.
4. Take advantage of dedicated day 0 webinar a week prior to the in-person event, with extensive opportunities to clarify your doubts.
5. Network with the industry leaders to understand what they do differently to be successful.

Who Should Attend:
Managing Directors, Directors, CXO’s, President, Sr. VP’s, VP’s, GM’s, Sr. Managers Managers and professionals from:
 Quality Assurance
 Quality Control
 Quality Compliance
 Regulatory Affairs
 Quality Audits
 Academia
 Anyone who has to be compliant with GMP, & Quality regulations