Eminence Business Media

Eminence Business Media

Saturday, April 13, 2024

The Nitrosamine Advanced Workshop 2024 to be held on May 9th - 10th, 2024 at Radisson Blu Mumbai

The presence of Nitrosamines, which are probable human carcinogens, has been an evolving challenge facing the pharmaceutical industry. Regulators became first aware of this impurity in mid – 2018, when NDMA was found in blood pressure medicine known as sartans. Ever since, the pharmaceutical industry has been working hard to mitigate the formation of Nitrosamines Impurities.

With the extensive research conducted by us, we have identified certain key challenges around nitrosamine formation, faced by the pharma manufacturers. We bring to you “Nitrosamine Advanced Workshop 2024” where we have experts from across the industry sharing their experience and expertise gained in this evolving concern.

To be held on May 9th – 10th, 2024 at Radisson Blu Mumbai International Airport, this workshop provides a comprehensive and in-depth exploration of nitrosamines, covering both updated regulatory guidelines and analytical understanding, and allowing participants to engage in practical discussions, case study solving sessions and hands-on learning experience. Join us to network with your industry peers and experts, discuss your challenges and get some practical solutions.

Why Attend:

1. Understand the ever-changing situation with Nitrosamines.
2. Discuss the evolving regulatory updates w.r.t Nitrosamines.
3. Dedicated time for Q & A to discuss and clarify your doubts.

Who Can Attend:

Designation:

             Managing Director
•             Director
•             CXO’s
•             President
•             Sr. VP’s
•             VP’s
•             GM’s
•             Sr. Managers
•             Managers
•             Professionals from:

Department:

             Analytical R & D
•             R & D
•             Quality Assurance
•             Quality Control
•             Manufacturing
•             Anyone handling Nitrosamine related Impurity profiling or monitoring.

Advance DoE Workshop 2024 to be held on May 9th & 10th, 2024 @ Hotel Radisson Blu Mumbai

For pharma and biopharma companies, building quality into your products from an early stage is a key factor in regulatory approval and market success. Thus, the FDA mentions “Design of Experiments” (DoE) as an essential tool for achieving both regulatory compliance and faster time to market. To help you build quality into your process as outlined by ICH Q8, Q9, and Q10, Eminence Business Media is planning a two-day robust training program on “Advance DoE Workshop 2024” on May 9th – 10th. 2024 focuses on Towards Implementing Pharma QbD: Recent Paradigms and Techniques of Quintessential DoE.

Here, our trainers will help you learn concepts of Advanced Level Statistical Concepts required to Optimize Processes & achieve Product Robustness. The 2-day program will help you learn:

             Plan, Design, Conduct, and Analyse experiments efficiently and effectively
•             Use response surface methods for system optimization as a follow-up to successful screening.
•             Use experimental design tools for computer experiments
•             Use software tools to create custom designs based on optimal design methodology

How will it help in your daily work?

             More insight and knowledge of the design of experiments leads to improved process variation, performance aligned with planning, shorter development times, more reliability and reduced costs.

What’s Next?

             Participants make better choices and schedules for experiments.
•             Participants can detect and discover interruptions early in the production process.
•             Participants can interpret test results in a more precise and complete fashion.

Who Attend?

Key Process Owners & core team members from the following departments of Pharma & Life Sciences

             Research & Development
•             Formulation & Development
•             Process Excellence
•             Professional scientists, researchers
•             Improvement engineers and managers involved in quality engineering
•             S.Q.C / S.P.C - production, Laboratory and quality assurance and regulatory affairs

Pharma Quality Excellence Awards 2024 to be held at Hotel Novotel Mumbai

The Pharma Quality Excellence Awards 2024 scheduled for April 26th in Hotel Novotel, Airport Road, Mumbai, is a prestigious event aimed at recognizing and celebrating the exceptional achievements of quality departments within the pharmaceutical industry. Eminence Business Media acknowledges remarkable contributions and unwavering dedication in the industry, and this award ceremony serves as a distinguished platform to recognize and appreciate the unwavering dedication, innovation, and commitment of individuals and teams who have demonstrated exceptional performance in upholding the highest standards of quality, safety, and efficacy in pharmaceutical products.

The awards program boasts a meticulously assembled Board of Jury comprising renowned industry experts, thought leaders, and regulatory authorities. The esteemed panel of judges brings a wealth of experience and expertise in quality management, regulatory compliance, and pharmaceutical best practices. Their collective insight and discernment ensure a rigorous and impartial evaluation process, guaranteeing that the most deserving individuals and teams receive the recognition they merit.

The 2024 edition of the Pharma Quality Excellence Awards will convene industry leaders, quality professionals, and stakeholders to celebrate excellence in a wide array of categories, including quality control, quality assurance, regulatory affairs, compliance, and overall quality leadership. This event aims to showcase best practices, cutting-edge techniques, and transformative initiatives that have significantly contributed to elevating quality standards across the pharmaceutical landscape.

By acknowledging and appreciating the efforts of quality professionals, the Pharma Quality Excellence Awards 2024 seeks to inspire a culture of excellence, foster innovation, and drive continuous improvement within the pharmaceutical industry. Through this esteemed platform, exceptional individuals and teams will gain well-deserved recognition for their pivotal role in ensuring the safety and efficacy of pharmaceutical products, ultimately advancing global public health.

EVENT INFORMATION:

EVENT: Pharma Quality Excellence Awards 2024

DESCRIPTION: The Pharma Quality Excellence Awards 2024 is a prestigious event aimed at recognizing and celebrating the exceptional achievements of quality departments within the pharmaceutical industry.

VENUE:  Hotel Novotel Mumbai International Airport
ON:  April 26th, 2024 - 7 PM
CONTACT: Shravan Nair
CONTACT NUMBER: +91 7517 672 770
CONTACT EMAIL: shravan@eminencemedia.in
URL: https://thepharmaawards.com

4th Annual Pharma GMP and Quality Management 2024

Following the resounding success of its 3rd edition, Eminence Business Media proudly presents the 4th Annual Pharma GMP and Quality Management 2024, scheduled for April 25th – 26th at Hotel Novotel, Airport Road Mumbai.

With the theme Transforming roles of ‘C’ in CGMP – Evolving & Optimizing Quality Systems, this confluence brings pharmaceutical experts to address the most pressing GMP practices and challenges with the intervention of Compliance, Culture, Communication, Class, and Chatbots….

This is event dedicated to fostering the exchange of knowledge, embracing best practices, and enhancing the capabilities of pharmaceutical companies in India, empowering them to adopt globally recognized standards with a strong emphasis on the technical intricacies of pharma quality.

This highly anticipated occasion will provide a comprehensive platform for industry experts to converge and delve deep into the technical nuances of Good Manufacturing Practices (GMP) and quality management.


The session is aiming to showcase in-depth discussions and immersive training sessions led by renowned thought leaders and practitioners to gain practical, technical skills and knowledge essential for ensuring compliance, product quality, and operational efficiency in pharma manufacturing.


To enhance the learning experience and better understanding and implementation, a virtual session is to take place on April 13th, 2024 with presentation based learning and dedicated Q&A round with 3 industry experts.


Let's connect and collaboratively shape the success of the 4th Annual Pharma GMP and Quality Management 2024.

Why Attend?

  •  In-depth discussions, case studies, group discussions and dedicated Q&A session for enhanced practical learning.
  •  Explore the impact of recent innovations in GMP & Quality Management 
  •  Gain insights through interactive live Q&A sessions and enjoy the advantage of extended 6-month support for continuous learning.
  •  Follow up virtual learning session with presentations and dedicated Q&A round 15 days after the conference.
  •  Network with your industry peers and understand what they do differently.

EVENT INFORMATION:

EVENT: 4th Annual Pharma GMP & Quality Management 2024

DESCRIPTION: This is an event dedicated to fostering the exchange of knowledge, embracing best practices, and enhancing the capabilities of pharmaceutical companies in India, empowering them to adopt globally recognized standards with a strong emphasis on the technical intricacies of pharma quality.

VENUE:  Hotel Novotel Mumbai International Airport
FROM:  April 25th, 2024 - 8:30AM
TO: April 26th, 2024 - 5:30PM
CONTACT: Shravan Nair
CONTACT NUMBER: +91 7517 672 770
CONTACT EMAIL: shravan@eminencemedia.in
URL: https://www.gxpqualitymanagement.com

Friday, April 12, 2024

Naxnova acquires Austria based Advanced Thermal Technologies (ATT)

Naxnova, a global leader in surface augmentation and technology solutions, formerly known as Classic Stripes, announced the successful acquisition of Advanced Thermal Technologies (ATT), a pioneer in thermal management solutions based in Austria, today. This strategic acquisition, quick on the heels of the acquisition of the Belgium based Quad Industries, marks another significant step forward in Naxnova's expansion strategy reinforcing their commitment towards delivering innovative solutions to customers worldwide.

ATT has built a reputation for design, development and manufacturing in Advanced Driver Assistance Systems (ADAS) Sensor and Camera Heating Solutions, Vehicle Cabin Solutions, Battery Heating Solutions, Battery Diagnostic Solutions, Seat Sensing & Heating Solutions, etc., serving a diverse range of industries including automotive, aerospace, retail and building. With world-class R&D capabilities and a track record of servicing marquee customers worldwide that includes prestigious OEM brands such as Porsche, Airbus, Daimler, Valeo, among others, ATT brings invaluable expertise and experience to the Naxnova family. Together with Advanced Thermal Technologies, the team aims to step up their offerings and deliver even greater value to customers and stakeholders worldwide.

Commenting on the second acquisition in the last 30 days, Mr. Salil Musale, Managing Director, Naxnova, shared, "This acquisition strengthens Naxnova's commitment to innovation and customer delight. By combining our strengths with those of Advanced Thermal Technologies, we aim to accelerate product development, expand market reach, and create new opportunities for collaboration and partnership. These ingenious solutions in the field of Thermal Management will become a huge requirement for OEMs globally to ensure safety monitoring, and enhance human comfort. ATT stands out as one of the very few companies that have advanced technology in thermal science.”

“With this acquisition, we aim to commercialise these products with our current customers and new customers in India. This acquisition combined with our earlier announced acquisition of Quad Industries, Belgium is a perfect example of our Hon’ble Prime Minister’s vision of Design and Make in India for the World,” he further added. 


By integrating ATT's cutting-edge technologies and expertise into Naxnova's portfolio, the team is poised to deliver enhanced value to our customers across various sectors. This acquisition not only strengthens their capabilities but also paves the way for aggressive development and commercialization of next-generation thermal management solutions for customers globally, especially in India.

In response to the acquisition, the founders of Advanced Thermal Technologies (ATT) expressed their enthusiasm and optimism. They stated, "Joining forces with Naxnova presents an exciting opportunity for us to further expand our reach and capabilities. We are proud of the reputation we have built in delivering innovative thermal management solutions to esteemed clients worldwide, and we are confident that together with Naxnova, we can achieve even greater success."

They continued, "Naxnova's commitment to innovation and customer satisfaction aligns perfectly with our own values, and we believe that this partnership will enable us to accelerate product development and offer enhanced value to our customers across various industries."

This second acquisition marks a new chapter of growth and innovation for the home grown company. While the recently acquired Belgium-based Quad Industries, along with ATT, will create a value chain leveraging the synergies between all three companies to provide innovation and next-generation solutions for customers on a global level.

Naxnova (previously, Classic Stripes) the flagship company of the Astarc Group, is a design & technology company providing new-generation solutions to global OEMs in the Automotive, Consumer Durables & Appliances industries in India. The global design technology organization provides a diverse product range of integrated surface augmentation solutions that includes decals, flexible 3D badges, overlays, smart surfaces and electronic solutions.  The company is a frontrunner in India to have rapidly advanced towards the research, product development, and commercialization of products enabled by printed electronics technology.

Operating from three state-of-the-art manufacturing facilities in India, Naxnova is creating a global and future-forward design and technology-first company with world-class manufacturing capabilities. The brand aims to achieve this through aggressive expansion and bolt-up acquisition plans globally, with next-generation products and solutions integrated with printed electronics technology that brands truly look for. Besides automotive, consumer goods and appliances, Naxnova will very soon be entering the medical devices & wearables industry. Naxnova prides itself on a dedicated workforce of over 1000 professionals serving customers in more than 16 countries, globally. In the automotive sector, the brand serves prestigious clients such as Yamaha, Ford, Honda, Suzuki, Tata Motors, Harley Davidson, KTM, Toyota, Hero, Bajaj, among others. Within the consumer durables segment, Naxnova serves leading names like Panasonic, Samsung, and more.

Thursday, April 11, 2024

Embracing the Intelligent Revolution: The Future of Labels and Packaging


The print industry has undergone a profound transformation over the past two decades. What was once dominated by long production series has now shifted towards shorter runs of customized products, tailored to meet the diverse needs and preferences of modern consumers. The demand for customization and variety continues to soar, yet with this surge in diversity comes a heightened level of complexity for the Labels & Packaging industry.

In an era where consumer habits evolve rapidly, regulatory requirements fluctuate, and e-commerce reshapes distribution channels, the ability to adapt quickly is key. Flexibility is the key to navigating this dynamic landscape, and digital technologies have emerged as a crucial enabler of agility.

Today, nearly one in two presses sold in the sector is digital. Within the next decade, we can anticipate this will increase to two in three. HP Indigo has been a pioneer, introducing liquid electrophotography (LEP) in the 1990s, which sparked this revolution and the results are evident today. The transition from conventional to digital printing has allowed for unprecedented flexibility in meeting client demands, with digital presses paving the way for swift adaptation to varying orders at no additional cost. However, all of this is ultimately just history.

As we look ahead, the real question is: What does the future hold for the Labels & Packaging industry? How will professionals in this sector operate in the coming years, and what transformations lie on the horizon? While no crystal ball can predict with certainty, several trends and developments offer insights into the path forward.

Digitalization will define the entire process
Digitalization is set to permeate every aspect of the production process, especially downstream. While we continue to see new entrants’ breakthrough and some finishers go 100% digital, there is still a way to go when compared to the 2000 HP Indigo machines operating in Labels & Packaging.

We know that by embracing digital processes across the production chain, from printing to the finished product, the industry stands to gain significant advantages in terms of productivity, waste reduction, and sustainability. Orders would be executed more quickly and the entire system would move towards zero stock and zero waste, less warehousing across the supply chain and ultimately greater efficiency and reduced environmental impact for both converters and their clients. A 100% digital process would lead to a decrease in quality defects, errors that result in waste, and value destruction.

Intelligent production lines are on the rise. We’re looking at a future where a job can be completed in just a few hours and ready to be delivered just a few later. But achieving this vision of a fully digitalized production ecosystem requires overcoming two critical challenges: standardization of file formats and seamless communication between machines. The ability to work from unified digital files containing both technical specifications and commercial data will streamline order management and facilitate rapid response to client needs. Similarly, enhanced connectivity between machines will enable real-time monitoring and optimization of production processes, driving efficiency and performance. These two challenges are by no means insurmountable and drupa 2024 will certainly be a moment where we’ll hear and see more.

In the packaging industry, information flows at the machine level transferring data across the production flow and to Human-Machine Interfaces (HMIs) so that the operators can control the machine and monitor its performance. This data also feeds into ERP systems and into a cloud infrastructure where it’s used to understand if a machine, a line, or even entire factories are operating well or not. The calculation of profitability relies on this today. Major corporations beyond printing, with dozens of factories worldwide, operating hundreds of production lines use this information to compare the performance of their sites. Very soon we could anticipate converters will operate in a similar manner - measuring the performance of their production lines, the idle rate of their presses, the number and type of breakdowns they experience, consumables consumption, job execution time, and production costs.

Robotics and intelligent systems will manage the flows
In an era where product differentiation and on-demand has become king, the number of substrates, films, primers, inks, and other coatings to be purchased, stored, and used is ever-increasing, efficient production cannot overlook more optimal management of all the flows of materials and supplies. As we look towards the future, the role of automation and robotics in managing material flows within factories will also become increasingly prominent. Accurate and real-time records of everything entering and leaving the production floor are critical, and as we look forward, we can expect the ERPs of printing companies will increasingly integrate traceability of these elements and finished products more efficiently, from the moment they leave the machines to the warehouse or the reconciliation area for swift shipping.

Logistics within printing production floors will also evolve to accommodate transport vehicles. Automated Guided Vehicles (AGVs) and Autonomous Mobile Robots (AMRs) are poised to revolutionize logistics within printing facilities, offering benefits such as improved inventory management, enhanced productivity and reduced reliance on human labor. By integrating these technologies into production workflows, manufacturers can achieve greater efficiency and responsiveness to changing demands. The automotive industry is already at the forefront of using these systems, while the printing & packaging industry is just beginning to adopt them. In the next five to ten years, we expect to see our industry follow suit.

And the ultimate layer?
After the flows between converters and packers, the last stage of this evolution will involve the retailers and the consumers. In about a decade we can expect entire production flows to be managed automatically by machines and robots, with a minimum of human intervention. Traceability will be complete. Both digital and physical exchanges between consumer’s order to retailers and to factories and warehouses will be seamless.

It's indeed only a matter of time that it will be the consumer who triggers the order at the very moment they purchase the product in the store or on-line. The financial transaction will initiate a series of reverse orders to go up the chain the moment a product sells, from the retailer to the producer, up to the ERP of the converter, which will instruct the press to manufacture the appropriate type of packaging and label. In a matter of days, the converter can manufacture all the required packaging and labels for the sold products and ship them to the packager who will have manufactured the products and sent them to the retailer, allowing him to almost replenish his stocks instantly. With these digital flows and operating a zero-stock model, printers will be able to better manage resource, embrace sustainability and ultimately, embrace higher profitability. Is it possible to do better?

AI will play a prominent role
Finally, the future of printing cannot overlook Artificial Intelligence (AI). The integration of AI promises to further enhance operational efficiency and quality control - detecting errors and correcting the work of printing, embellishment, or cutting systems on its own. AI-driven algorithms can also optimize machine performance, predict maintenance needs, and even assist in decision-making processes. From quality control to predictive maintenance and supply chain optimization, AI holds the potential to revolutionize every aspect of the printing and packaging industry.

Label converters are on the front line
In this rapidly evolving landscape, label and packaging is at the forefront of innovation. As the first sector to undergo its digital revolution thirty years ago, the industry is well-positioned to embrace emerging technologies. The next twenty years promise a paradigm shift in the way printing and packaging are conceptualized and executed. With digitalization, automation, and AI-driven optimization at the forefront, the industry is poised to enter a new era of quality, versatility, productivity, sustainability, and profitability. As we navigate this intelligent revolution, one thing is clear: the future of printing and packaging is bright, and the possibilities are limitless.

By Haim Levit: SVP & Division President, HP Industrial Print

Friday, July 28, 2023

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.