6th Annual Pharma Regulatory Summit 2023

                         6th Annual Pharma Regulatory Summit 2023

                                28th March 2023, Hotel Kohinoor Continental, Mumbai, India

6th Annual Pharma Regulatory Summit 2023 brings together leading global pharmaceutical industry professionals and regulators to share their insights on technologies, approaches, and solutions that will drive innovation and quality for the medicines delivered to patients worldwide. This interactive setting with expert-led regulatory and industry presentations and forums will ensure pharmaceutical industry professionals are well-prepared to develop and apply innovative solutions in today’s global regulatory environment.

DELEGATE REGISTRATION:

E-mail - bookings@virtueinsight.com or Call - + 91 44 42108101/+91 9361957193

Standard Price  - (INR 15,000 + GST (18%) per delegate)

SPONSORS:

CLINEXEL Life Sciences, Chitkara University, Ancillarie, Amplexor Life Sciences, Clinevo Technologies, ADVENT CHEMBIO

Conference Sponsor, Exhibition Stall & Paid Speaker Slot - Please email your interest and queries to bookings@virtueinsight.com 

 KEY SPEAKERS:

• ATUL NASA, Vice Chancellor, SGT University (Former Drugs Control Officer, Drugs Control Department)
• MAYUR PARMAR, Drugs Inspector, FDA (Deputy Collector, Gujarat Government)
• RASHMI HEDGE, Executive Vice President – Medical, GSK
• MUKESH KUMAR, Senior Vice President & Head, Clinical R&D, Cipla
• ANIL PAREEK, President Medical Affairs & Clinical Research, Ipca Laboratories
• NITIN CHANDURKAR, Vice President, Clinical Research and Development
• PRATIK SHAH, VP - Medical Affairs, Bharat Serums and Vaccines
• AVINASH R. KAKADE, Vice President & Head of Pharmacovigilance, Cipla
• GEETA SHANBHAG, Vice President - Pharmacovigilance & Medico-regulatory Affairs, Ipca Laboratories
  
• RAHUL GUPTA, Vice President, Regulatory Affairs, USV
• SOFI JOSEPH, Regulatory Affairs & Pharmacovigilance, Director, Servier
• MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates
• YASMIN SHENOY, Senior Director - Regulatory Affairs, Sanofi
• ANJU AGARWAL, Director, Global Patient Safety, Advanz Pharma
• SEEMA PAI, Director Clinical Site Operations – India Cluster, Pfizer
  
• SHIRAZ KANDAWALLA, Associate Director - Regulatory Affairs, Ferring Pharma
• DILIP PAWAR, Global Head - Medical Affairs and Pharmacovigilance, Unichem Laboratories
• BOBBY GEORGE, Vice President & Group Head Regulatory Affairs, Reliance Life Sciences
• DEEPA ARORA, Chief Executive Officer, CLINEXEL Life Sciences
  
• SWEETY MATHEW, Regulatory Professional, RA CMC Biotech & Rare, Disease, Novo Nordisk
• RANJIT BARSHIKAR, CEO, QBD International, United Nations Adviser
• AMITA BHAVE, Head Regulatory Affairs GDD India, Novartis
• RANJIT BARSHIKAR, Member of the Editorial Board, Journal of Generic Medicines – England
• BINDHU LATHIKA, Associate Director, Biocon
• DARREN PUNNEN, Leader, Pharma and Life Sciences Practice, Nishith Desai Associates
• VAIBHAV SALVI, Head - Medical Information, Asia, Vaccines and CHCm, Sanofi
• HARSHAD KOTHAWADE, Director, Head of Regulatory Management & Trade Compliance India, South East Asia, ANZ, Merck Group
• SADANAND KULKARNI, Head- Medical, Regulatory, Vigilance and Quality, Fresenius Kabi
• NEERAJ MARKANDEYWAR, DGM-Medical Affairs, Sun Pharma
• APARNA PRABHUNE, Asst General Manager Regulatory Affairs, Wockhardt

Puls More Joining Soon

KEY THEMES DISCUSSED:

• Current regulatory framework – Making the best out of the situation
• Outlining major legal challenges currently being faced – Ways to cross these barriers
• The Pharma Regulations in India: The Good, The Bad, The Ugly
• Current regulatory compliance issues & opportunities for regulatory authorities & industry
• Impact of technology - How digital applications conflict with the legal & regulatory landscape?
• Recent Clinical development - Recent regulatory updates – The new normal
• Remote trials – finally the reality – Regulations
• Overcoming the main challenges of filing variations in India
• Prioritizing patient - Safety regulations
• Modern issues and maintaining quality in medical writing
• Exploring the current biosimilar legal landscape
• Evolving opportunities and challenges in medical devices regulations
• Overcoming key challenges with product registration in India
• Outlining key requirements for filing variations in India
• Practical guidance for drug registration compliance in India
• Navigating the best regulatory pathway for successful drug approval
• Be part of a major networking opportunity

WHO SHOULD ATTEND AND WHO YOU’LL MEET:

This conference is specifically designed for pharma, biotech, CRO’s, Government and Regulators, Hospitals/Trial Sites, Technology & Solution Providers and medical device professionals responsible for:

Regulatory Affairs, Regulatory Writing/Medical Writing/Publishing / Information/ Submissions, Document and eRecords Management, Drug Safety, Business Operations/Processing, Labelling, Clinical Trials Management/Data, Clinical Data, Outsourcing/Clinical Outsourcing/Vendor Management, Product Development, Quality Assurance/Quality Control,Patient recruitment companies, Government- Department of health, Non-profit organizations/ Association, Consultants.

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.