3rd Annual Pharma Regulatory Summit 2020

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3rd Annual Pharma Regulatory Summit 2020
Date 2020-03-12
Place Kohinoor Continental Hotel

Andheri Kurla Road, Andheri ( E ), Mumbai 400059 India

Pharma Regulatory Summit is the leading platform for regulatory experts, to be updated with latest country updates and strategies to navigate the complex and ever changing regulations in the region. This conference will focus on the new strategies, amendments, innovations, developments in the fields of regulatory affairs, intellectual property and medical devices, which reflects new strategies in the field of regulatory affairs.

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Speaker Highlights

·         RASHIDA NAJMI, Snr Vice President Global- Quality, Regulatory Pharmacovigilance and Patents, Piramal

·         SEEMA PAI, Director- India Cluster Global Site & Study Ops, Clinical Dev & Ops, GPD, Pfizer

·         KIRAN MARTHAK, Directors-Mgmt, Lambda(Vice Chairman of Medical Committee, Indian Drug Manufacturers’ Association

·         RAJENDRA SANGHAVI, Sr. Consulting Clinician & Chairman - Medical Committee, Indian Drug Manufacturers’Association

·         V. KALAISELVAN, Principal Scientific Officer, Indian Pharmacopoeia Commission

·         PRASANNA BANGALE, Vice President & Head, Global Regulatory Affairs, Alembic Pharmaceuticals

·         MAHESH ABHYANKAR, Vice President - Medical and L and D, USV

·         ARUN GUPTA, Head Medical Affairs & Clinical Research, Dabur Research & Development Centre

·         ARIF KHAN, Head – Regulatory Affairs, Pharmacovigilance and Medical Information, UCB

·         AVINASH R. KAKADE, Pharmaceutical Physician Leader | Medical Doctor | Perpetual Learner | Mentor, Indian Institute of Management Rohtak

·         MANISH MAHAJAN, Head- Medical Affairs, Cadila Healthcare Ltd. (BU- Biologics)

·         KEDAR SUVARNAPATHAKI, Head - Regulatory Affairs & IP, Boehringer Ingelheim

·         AMITA BHAVE, Head Regulatory Affairs GDD India, Novartis

·         CHIRAG TELI, Head of Medical Services, Alkem Laboratories

·         ANISH DESAI, Director Medical Affairs,Clinical Ops. and Device safety, Johnson & Johnson

·         NARESH TONDARE, Senior Director - National Regulatory Affairs, Biocon

·         RAJESH KHER, Director, Business Operations, Regulatory Medical Writing, Janssen R&D

·         SHIRAZ KANDAWALLA, Associate Director - Regulatory Affairs, Abbott

·         RANJIT BARSHIKAR, QbD / CGMP Consulting, Member Editorial Board Journal of Generic Medicines, England

·         PRATIK SHAH, (Former Head - Clinical, Medical & Regulatory, PV & QA Astellas), Independent Consultant

·         ACHARYA SESHU BABU MARINGANTI, Business consultant, Former - Global Regulatory Operations, QA Operations, Abbott

Plus many more to join soon

Sponsors

Sponsor, Exhibition Stall (Booth) and a paid Speaker Slots are also available.

We have more sponsorship opportunities available for the event, which gives you an opportunity to sponsor/speak/exhibit/Booth/Stall and create brand awareness. In addition, the networking opportunities in focused and relevant industry gathering provide the personal contact necessary for business development efforts

DELEGATE REGISTRATION

E-mail - kavitha@virtueinsight.co.in or  T: +91 44 24762472

Early Bird Discounted Price (Vaild till 24th Jan 2020) – (INR 10,000 + GST (18%) per delegate)

Standard Price  (Vaild from 25th Jan 2020) – (INR 15,000 + GST (18%) per delegate)

KEY THEMES DISCUSSED

  • Understanding the current regulatory framework
  • Overcoming key challenges with product registration in India
  • Determining best strategies for the application and approval of variations in India
  • Outlining key requirements for filing variations in India
  • Current regulatory compliance issues and opportunities for regulatory authorities and industry experts
  • Overviewing the current regulatory landscape in 2020 & 2021
  • Clinical evidence for regulatory purposes
  • Purpose of the public workshop. Bringing the team of investors together to discuss key issues for the use of randomized designs
  • Exploring the current biosimilar legal landscape
  • Studying the latest battles occurring in the biosimilar domain
  • Developing scenarios for the Asian pharma market
  • Top line innovation trends and implications
  • The regulatory reform of India and its effect on the pharmaceutical industry
  • Discussing the requisite collaboration between pharmaceutical companies and government agencies
  • Digital regulatory innovation and advanced technology
  • Insight into the future of regulatory issues in the digital world and how businesses need to adopt advanced technology to challenge the traditional way in which regulatory data and application processes are managed
  • Practical guidance for drug registration compliance in India
  • Navigating the best regulatory pathway for successful drug approval
  • Be part of a major networking opportunity

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