5th Annual Pharma Regulatory Summit 2022

                                           5th Annual Pharma Regulatory Summit 2022

                                          09th & 10th March 2022, Virtual Conference (Time Zone – IST)

India is the 4th largest market of medical devices in Asia and counted amongst the top 20 markets in the world. In 2020, the total market was estimated to be US$5.2 billion and is projected to reach US$50 billion by 2025. Today Indian Pharma Sector can be attributed to world-class capabilities in formulation, the entrepreneurial skill and the vision of the industry to establish India’s footprint in large international markets such as the United States, Canada, Europe and Japan. The US market, which accounts for a third of India’s Pharma exports, recording over 14.5% growth over last fiscal.

Join us to discuss multi-regional cooperation, global harmonization and best practices related to India’s regulatory landscape. Sessions will highlight regulatory approaches and good practices to ensure certainty in India and strategic initiatives to improve collaboration and cooperation.

DELEGATE REGISTRATION:

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

• Standard Price   - (INR 9,000 + GST (18%) per delegate)
• Conference Sponsor, Exhibition Stall & Paid Speaker Slot - Please email your interest and queries to bookings@virtueinsight.com

KEY SPEAKERS:

• K BANGARURAJAN, Adviser, CDSCO (New Delhi)
• MAYUR PARMAR, Deputy Collector, Government of Gujarat
• RAJENDRA SANGHAVI, Sr. Consulting Clinician & Medico-Marketing & TechnoRegulatory Consultant - Healthcare Industry & Chairman - Nutraceutical Committee, Indian Drug Manufacturers’ Association (IDMA)
• KIRAN MARTHAK, Director- Medical and Regulatory Affairs, Veeda Clinical Research
• RASHMI HEGDE, Executive Vice President Medical Affairs, GSK
• PRASANNA BANGALE, Vice President and Head, Global Regulatory Affairs, Alembic Pharmaceuticals
• PRATIK SHAH, Vice President Medical Affairs, Bharat Serums and Vaccines
• OMPRAKASH S. SADHWANI, Former Joint, Commissioner and Controlling Authority, FDA (Maharashtra state)
• NAVANEETHA SELVAN, Associate Vice President - Global Regulatory Affairs, Wockhardt
• ARANI CHATTERJEE, Senior Vice President, Clinical Research, Aurobindo Pharma
• SANJAY SHARMA, Vice President Technology Transfer, Lupin
• TAUSIF AHMED, Vice President & Head Biopharmaceutics & Bioanalytical, Global Clinical Management, Dr. Reddy's Laboratories
• SAILAJA SAYANA, Senior Director & Head - Global Pharmacovigilance, Biocon
• KAVITA LAMROR, Director, Real World Investigator, Digital Function, Sanofi
• NITISH CHAKRAVARTY, Vice President - Secondary Manufacturing, Biological E
• AMIT BHARGAVA, Director, H.E.A.R.T of Medicine (Former VP, Lupin)
  
• MANISH MISTRY, Medical Director, Novartis
• VAIBHAV CHOUDHARY, Joint Director, Medical and Clinical Affairs, Fresenius Kabi Oncology
• RAJESH KHER, Director, Business Operations, Regulatory Medical Writing, Janssen
• APARNA JAYACHANDRA, Director - SERM, Safety Sciences India, GSK
• ANUP CHOUDHURY, Medical Director, Global Clinical Development, Novartis
• DEEPA ARORA, Founder - Director, CLINEXEL Life Sciences
• ANJU AGARWAL, Director Global Patient Safety, Advanz Pharma
• RISHI JAIN, Medical Director, AbbVie
  
• SUMIT SANT, Director, Clinical Safety, Global Product Safety and Risk Management, Viatris
• AMEY MANE, Director Medical Affairs, Dr. Reddy's Laboratories
  
• DURGA MANE, Associate Director Quality Assurance, Cognizant
• MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates
• KUMAR GAURAV, Director Medical Affairs, Dr. Reddy's Laboratories
  
• YATEEN SHAH, Director - Regulatory Affairs & Quality, Johnson & Johnson
• SOFI JOSEPH, Regulatory Affairs & Pharmacovigilance Director, Servier India
  
• DILIP PAWAR, Head - Medical Affairs and Pharmacovigilance, Unichem Laboratories
• SUMIT ANAND, Associate Director Clinical Operations, Abbott
• VIPUL JAIN, Associate Director - SCM Integrated Business Planning, Cipla
• SHAHU INGOLE, General Manager, Head Medical Affairs, Wockhardt
  
• MANGALA KOTNIS, Head Regional Medical Affairs, Abbott
• SANDEEP ARORA, Medical Affairs Head, Takeda
• VAIBHAV SALVI, Head – Medical Information, Asia, Sanofi
• SADANAND KULKARNI, Head-Medical, Regulatory, Vigilance, Quality, Fresenius Kabi
  
• RAJESH PEDNEKAR, Head - Supply Chain, Operations and Strategy, Healthcare SF
• VISHWAS SOVANI, Founder Director, Pharmawisdom
• VARSHA KHATRY, Head Medical and Scientific Affairs, Quality and Regulatory, Roche Diabetes Care, India
• VIPIN SETHI, Global Pharmacovigilance Head – Medical Affairs, Cadila
• GEETA SHANBHAG, Sr. General Manager – Pharmacovigilance & Medico-Regulatory Affairs, Ipca Laboratories
• RAJENDRA JANI, Senior Subject Expert & Advisor, Clinical Research Consultant
• SANJIV DONWALKAR, Pharmaceutical Consultant (Former OpEx Head, Sandoz)
• NEHA VALA, Head- Pharmacovigilance, Emcure Pharmaceuticals
• BHARAT BHUSHAN RATHI, Head Logistics, Mankind Pharma
  
• RAVI GAWARE, Head of Clinical Operations, Novo Nordisk
• GANESH KADHE, Senior Leadership Team Member, Scientific & Medical Affairs, Abbott Nutrition
• APARNA PRABHUNE, Asst General Manager Regulatory Affairs, Wockhardt
• SUDIPTO BASU, Head Planning, Boehringer Ingelheim
• KAVYA KADAM, Consultant, Global Clinical Trials
• INDRANIL PURKAIT, General Manager and Head Medical Affairs, Ipca Laboratories
  
• MANJIRI WARANG, Medical Writing - Clinical Development, Sun Pharma

Plus more joining soon

KEY THEMES DISCUSSED:

• The new normal for clinical development regulatory practices - Staying ahead of regulatory changes
• Lessons to learn from Covid pandemic - Potential benefits and risks of regulatory flexibility Striking the balance
• Present regulatory system for growth and effective production of medicinal products
• New regulations in Pharmacovigilance and the way forward
• The role of technology within regulatory compliance
• Prioritizing patient safety regulations
• Discussing how to ensure operational performance in compliance with the aim of better regulation
• New changes in Drug Supply Chain Security Act (DSCSA).
• Recent developments in GCP. How to succeed with this?
• Usage of mobile apps and medical devices in clinical trials – regulatory challenges
• RWE implementation in clinical trials. What are the challenges, chances and curses?
• Moving to electronic package-level traceability system – steps and barriers.
• Regulatory issues and maintaining quality in medical writing.
• Regulatory environment for medical devices in India as per 'New Medical Devices Rules'?
• Relationship between regulatory and technology in medical devices? A better understanding.
• What are the critical regulatory aspects for biotech companies? What should they look out for?
• Biosimilars market regulation, what are the benefits and drawbacks?
• Understanding the CGMPs under post pandemic. What changes will take place in priorities?
• Effective plans to maintain manufacturing and packing drug product methods under CGMPs?
• Ways to improve the combination of quality, safety and effectiveness in manufacturing.
• Be part of a both (together and one) virtual 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 e-Records Management
• 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