2nd Annual Pharma Regulatory Summit 2019

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2nd Annual Pharma Regulatory Summit 2019
Date 2019-03-14
Place Kohinoor Continental Hotel

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

This 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. Regulatory Affairs additionally have certain significance inside the Healthcare industries, such as pharmaceuticals, medical devices, biologics and practical nourishments.

Top Photos

Top Videos

Speaker Highlights

·         RAMKISHAN, Deputy Drugs Controller, DDC(I), CDSCO

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

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

·         MAYUR PARMAR, Deputy Collector, Government Of Gujarat

·         KETAN KOTADIYA, Associate Director- Regulatory Affairs, Merck Sharp & Dohme

·         SHANTANU MUKHERJEE, Legal Head, Asia Pacific and Japan, Lupin

·         OMPRAKASH S. SADHWANI, Former Joint Commissioner and controlling Authority, Food and Drug Administration (Maharashtra state)

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

·         AMITA BHAVE, Head Regulatory Affairs GDD India, Novartis

·         RAJESH NAIK, Head Medical Affairs Oncology, Boehringer Ingelheim

·         ALAP GANDHI, Head, Medical Affairs, GSK

·         RITU JOHARI, Head-Scientific Affairs, Quality & Regulatory, Abbott Diabetes Care

·         MILIND NARVEKAR, Head Regulatory Affairs, Apotex Research

·         S.R.SALUNKHE, Former Assistant commissioner, FDA Maharashtra

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

·         VIJAYA ANAND, Chief Manager - Corporate Regulatory Affairs, Piramal

·         NISHA FERNANDES, Manager - Regulatory Affairs, Amgen

·         HITENDRA BHATIA, Independent Consultant – Regulatory Affairs

Key Themes

  • Visions for the future – Pharma Regulatory 2020
  • Current state of regulatory compliance in Pharma industry
  • Global regulatory challenges and current hot topics in the regulatory world
  • Conducting an innovative and commercialization hub in India
  • Conception and Digitalisation – The impact and where do we go next?
  • Directing the regulatory environment in India
  • Expedited approval timelines and process - Overview and case studies
  • Discussing on the recent harmonization regulatory efforts in Asia for the pharma products
  • Companies & Gov – How should they work together? 
  • Different regulatory obligation for enrolling drug products for the regulatory process for obtaining marketing authorizations for drugs in ASEAN region
  • Compendial standards usage for quality medicine regulation
  • Post-Marketing surveillance & safety in India
  • Post marketing monitoring and evaluation of the safety and effectiveness of all medicines
  • Impacts and Opportunities for IP strategies in regulatory affairs – Globally & Digitally
  • Future conceptualization for IP strategies and its regulatory significance
  • An essential management aspect on GMPs
  • Keeping tracks on GMP production and quality control
  • Leading quality manufacturer in regulated industries including food, drugs and medical devices
  • India’s current regulatory scenario and structure – what’s changed and what else to expect
  • Be part of a major networking opportunity

Who Should Attend

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

Regulatory Affairs, Regulatory Writing, Medical Writing, Publishing, Information, Submissions, Document and eRecords Management, Business Operations, Processing, Labelling, Clinical Trials Management, Data, Clinical Data, Outsourcing, Clinical Outsourcing, Vendor Management, Product Development, Quality Assurance, Quality Control

Conference Registration

E-mail - kavitha@virtueinsight.co.in  Tel: +9144 24762472

·         Early Bird Discount Price (Ends 28th January 2019) – (INR 10,000 + GST (18%) per delegate)

·         Standard Price (From 29th January 2019 Onwards) – (INR 15,000 + GST (18%) per delegate)

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

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

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