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.
