3rd Annual Pharma Regulatory Summit 2020

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues

09:20 – Chairperson opening remarks

RANJIT BARSHIKAR, CEO - QbD International, United Nations Adviser, Member Editorial Board Journal of Generic Medicines, England

MARKET OVERVIEW & ANALYSIS

09:30 - FDCs - Boon or Bane

•   FDCs are flagship of India’s formulations.
•   Ridiculing FDCs sans sound medical basis will spell inconvenience for patients and compromise outcomes in chronic therapies.
•   Differentiating between those justifiable and those scientifically irrational holds the key to future of FDCs.
•   Governing rational FDCs prescribing is more a regulatory and a medical challenge rather than implicate the healthcare industry.
•   Unbiased SOPs required to ensure necessary FDCs for patient’s welfare.

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

10:00 - Upsurge of Real World Evidence and Regulatory Decision Making

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

10:30 – Morning Coffee/Tea & Discussion

CHALLENGES & OPPORTUNITIES

10:50 - DISCUSSION WITH EXPERTS: Current regulatory compliance issues and opportunities for regulatory authorities and industry experts

•   Overviewing the current regulatory landscape in 2020 & 2021
•   How pharmaceutical companies stay ahead of these changes?
•   How digital applications conflict with the legal and regulatory landscape?
•   Clear specifications for registration and regulation of pharmaceutical products and medical devices in India
•   Challenges in securing authorization from authorities for medical devices
•   Regulations on trial guidelines, devices, safety, approval and market access
•   Discussing strategies about global marketing campaigns for biosimilar products

Moderator
RANJIT BARSHIKAR, CEO - QbD International, United Nations Adviser, Member Editorial Board Journal of Generic Medicines, England

Panellists
AVINASH R. KAKADE, SGM, Global Head - Pharmacovigilance, Lupin Global
ROHIT ARORA, Medical Director, Eli Lilly
OMPRAKASH S. SADHWANI, Former Joint Commissioner and controlling Authority, Food and Drug Administration (Maharashtra state)
SAKHARAM GARALE, Head South-East Asia Operations ACMA & Managing Partner, RENOVARE Healthcare Solutions
KAVYA KADAM, Consultant Global Clinical Trials

11:30 - DISCUSSION WITH EXPERTS: Clinical evidence for regulatory purposes

•   Using randomized clinical trials for regulatory purpoes to generate real-world evidence
•   Purpose of the public workshop. Bringing the team of investors together to discuss key issues for the use of randomized designs
•   Explore key considerations for using randomized designs of clinical trials and real-world data (RWD) to generate RWE, especially in clinical care settings
•   Possible integration of clinical trials into the health care system through the use of randomized designs to generate RWE for regulatory applications
•   Use of real-world evidence to support medical device regulatory decision-making
•   Data collected from other sources, such as mobile devices, that can inform about health status

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

Panellists
DEEPA ARORA, Director, CLINEXEL Life Sciences
ANISH DESAI, Director, IntelliMed Healthcare Solutions
CHIRAG TELI, Head of Medical Services, Alkem Laboratories
ANANT PATIL, Asst Professor Department of Pharmacology, Dr DY Patil, Medical College

12:10 - Clinical and regulatory considerations of Drug Device Combination Products- Human factors/usability testing studies, PMS plan, PMCF Plan

•   Relevant US and EU regulations for Drug Device combinations
•   Relationship of Human Factor and Major Clinical Studies of combination Products
•   Considerations for Submission of Combination Products Human Factors Study data
•   Tailored HFE Processes
•   Key aspects of Developing cost effective, efficient PMS and PMCF Plan

DEEPA ARORA, Director, CLINEXEL Life Sciences

12:40 - Networking luncheon

13:50 – Understanding the current regulatory framework

•   Current regulatory environment and any recent changes
•   Overcoming key challenges with product registration in India
•   Best strategies for product registration
•   Outlining major legal challenges currently being faced

SAKHARAM GARALE, Head South-East Asia Operations ACMA & Managing Partner, RENOVARE Healthcare Solutions

14:20 – DISCUSSION WITH EXPERTS: Clinical Regulatory Medical Writing – Ensuringregulatory standards are met in structured and manageable timeline

•   Regulatory medical writer: More than a writer, an expert
•   Establish patient anonymization and de-identification processes that satisfy transparency requirements while preserving the integrity of the clinical research
•   Increase the quality and speed of protocol writing by leveraging various templates
•   Analyze the benefits of having a medical writer as a strategic partner in document preparation and submission planning
•   Create models for working with vendors/contractors that can be adapted for changing program and document needs
•   Develop effective onboarding and mentoring programs that will allow you to recruit millennials and train the next generation of medical writers

Moderator
VISHWAS SOVANI, Founder Director, Pharmawisdom

Panellists
KIRAN MARTHAK, Directors - Management, Lambda (Vice Chairman of the Medical Committee), Indian Drug Manufacturers’ Association (IDMA)
PRAVIN GHADGE, Head of Clinical Research Services, Reliance Life Sciences
SEEMA GURBANI, Offering Lead- Medical Writing and Medical Affairs [LifeSciences- North America Region], Tata Consultancy Services

15:10 – Afternoon Tea/Coffee

15:30 – Biosimilar and Healthcare Care Professionals: Need Gaps

•   HCP perceptions of Biosimilars
•   HCP views: Evidences on Biosimilars
•   Barriers and Facilitators to prescribe Biosimilars
•   Patients perceptions to Biosimilars

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

16:00 – DISCUSSION WITH EXPERTS: The Pharma Regulations in India: The Good, The Bad, The Ugly

•   Pharmaceutical regulatory landscape in India
•   Are regulations becoming strangulations for Pharma sector in India?
•   Putting best foot forward with current regulations
•   Pharma Regulatory Maize in India: Can there be winner?
•   Navigating Regulatory Pathways to Address unmet medical needs
•   Real World Evidence: Improve your regulatory intelligence for better business outcomes
•   The Indian pharmaceutical industry – the way forward

Moderator
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates

Panellists
PRASANNA BANGALE, Vice President & Head – Global Regulatory Affairs, Alembic Pharmaceuticalst
GIRISH PARHATE, Vice President – Regulatory Affairs, India, Dr. Reddy’s Laboratories
SHIRAZ KANDAWALLA, Associate Director - Regulatory Affairs, Abbott
AMITA BHAVE, Head Regulatory Affairs GDD India, Novartis
HITENDRA BHATIA, Manager Regulatory Affairs, Procter & Gamble Health

16:50 - Chairperson’s closing remarks and end of conference