5th Annual Pharma Regulatory Summit 2022

5th Annual Pharma Regulatory Summit 2022 is organized by Virtue Insight and will be held from Mar 09 - 10, 2022.

Who Should Attend And WhoYou'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

Conference Introduction:
In the pharmaceutical sector specifically, the global regulatory affairs outsourcing market is expected to be worth $14.3 billion by 2026, a CAGR of 12%.1 Meanwhile, the whole medical device outsourcing market is expected to be worth over €230 billion by 2027. There is clearly a growing trend for quality, compliance and regulatory outsourcing and it is likely to be accelerated by the healthcare crisis. The Indian Pharmaceutical industry is expected to grow to USD 100 billion by the end of 2025 Pharmaceuticals exports from India stood at USD 16.3 Billion in FY 2019-20.The Indian biotechnology industries was valued at US$ 64 billion in 2019 and is expected to reach US$ 150 billion by 2025.

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. This high import dependency offers an attractive proposition for domestic manufacturers. At present, the Indian companies are largely involved in manufacturing low-end products for local as well as international consumption. The Indian Pharma market is the third largest in terms of volume and 13th largest in terms of value and 20 per cent in the volume.

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

Key Speakers:
• RAJENDRA SANGHAVI, Sr. Consulting Clinician & Chairman - Medical Committee, Indian Drug Manufacturers' Association (IDMA)
• RASHMI HEGDE, Executive Vice President Medical Affairs, GSK
• AMIT BHARGAVA, Vice- President and Head- Medical Services, Lupin
• PRASANNA BANGALE, Vice President and Head, Global Regulatory Affairs, Alembic Pharmaceuticals
• PRATIK SHAH, Vice President Medical Affairs, Bharat Serums and Vaccines
• NAVANEETHA SELVAN, Associate Vice President - Global Regulatory Affairs, Wockhardt
• SANJAY SHARMA, Vice President Technology Transfer, 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
• ANJU AGARWAL, Director Global Patient Safety, Advanz Pharma
• KRANTHI KIRAN PEBBILI, Director and Cluster Head - Medical Affairs, Dr. Reddy’s Laboratories
• SHIRAZ KANDAWALLA, Associate Director - Regulatory Affairs, Abbott
• AMEY MANE, Director Medical Affairs, Dr. Reddy's Laboratories
• PRAVEEN KUMAR L, Director - Regulatory Affairs, Cipla
• YATEEN SHAH, Director - Regulatory Affairs & Quality, Johnson & Johnson
• KAVITA LAMROR, Director, Real World Investigator, Digital Function, Sanofi
• VIPUL JAIN, Associate Director - SCM Integrated Business Planning, Cipla
• SHAHU INGOLE, General Manager, Head Medical Affairs, Wockhardt
• MANGALA KOTNIS, Head Regional Medical Affairs, Abbott
• VAIBHAV SALVI, Head – Medical Information, Asia, Sanofi
• VICKRAM SRIVASTAVA, Head of Planning - Global Supply Chain, Sun Pharma
• SADANAND KULKARNI, Head-Medical, Regulatory, Vigilance, Quality, Fresenius Kabi
• VARSHA KHATRY, Head Medical and Scientific Affairs, Quality and Regulatory, Roche
• GEETA SHANBHAG, Sr. General Manager – Pharmacovigilance & Medico-Regulatory Affairs, Ipca Laboratories
• RAJENDRA JANI, Senior Subject Expert & Advisor, Clinical Research Consultant
• SANJIV DONWALKAR, Head - Operational Excellence, Novartis
• ASHWANI PANDITA, General Manager - Clinical Quality Management & Training, Glenmark
• 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, Senior Manager - Demand Planning, Boehringer Ingelheim
• INDRANIL PURKAIT, General Manager and Head Medical Affairs, Ipca Laboratories
• MANJIRI WARANG, Medical Writing - Clinical Development, Sun Pharma
Plus many more joining soon

Key Themes Discussed in This Conference:
• The new normal for clinical development regulatory practices - Staying ahead of regulatory changes
• New EU CTR (536/2014) - being implemented in Jan 2022 and proposed draft IND safety reporting guidance from US FDA
• 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

Why Should You Attend?
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

What are the benefits of attending?
• Meet your peers in an interactive, discussion-based format designed to maximize knowledge transfer and networking
• Enjoy our informal networking at drinks and lunch
• Meet the leading solution providers in the market to forge partnerships and discover solutions
• Receive electronic versions of the conference documentation for use of reference post-event.
• Get ideas for?training topics?that you might want to present as professional development sessions to others in your workplace.
• Observe speakers from the perspective of seeing what works really well so you can learn new public speaking techniques and strategies that you can apply when doing your own presentations.
• Learn what not to do in presentations if you end up sitting through any sessions that fail to be engaging or informative.
• Delegates also benefit from discounted rates onfuture event attendance