2nd Annual Pharma Regulatory Summit 2019

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

09:20 – Chairperson opening remarks

MARKET OVERVIEW & ANALYSIS

09:30 – Quality risk management in pharmaceuticals

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

10:00 – Regulatory insights, related trends and use of automation in Reg operations

VISHAL MHATRE, Associate Vice President - Regulatory Affairs, Tata Consultancy Services

10:30 – Morning Coffee/Tea & Discussion

CHALLENGES & OPPORTUNITIES

10:50 – DISCUSSION WITH EXPERTS: Directing the regulatory environment in India

•   Expedited approval timelines and process - Overview and case studies
•   What are the commonly-encountered challenges in drug approval processes - Discussing the regulatory pain points
•   Issues while sourcing medical devices product approvals from authorities
•   Challenges on new clinical trials regulation (536/2014) – A brief introduction
•   Regulating operations for AI and future regulatory operation models globally. What are the new solutions?
•   Present regulatory outlook developments for biologics and updates on registration & variation guidelines

Moderator
MUBARAK NAQVI, Medical Head of Insulins: Emerging Markets, Global Medical affairs, Sanofi

Panellists
RUBINA BOSE, Deputy Drugs Controller(India), CDSCO (WZ)
SHIRAZ KANDAWALLA, Associate Director - Regulatory Affairs, Abbott
ALAP GANDHI, Head, Medical Affairs, GSK
HITENDRA BHATIA, Manager Regulatory Affairs, Merck (A Procter & Gamble Company)
UJWALA V. SALVI, Founder & Chief Executive Officer, Nucleon Therapeutics
RITIKA GANJU, Partner, Phoenix Legal

11:30 – DISCUSSION WITH EXPERTS: Discussing on the recent harmonization regulatory efforts in Asia for the pharmaceutical products

•   Different regulatory obligation for enrolling drug products for the regulatory process for obtaining marketing authorizations for drugs in ASEAN region
•   Proactively address and avoid costly delays for product launch by evolving ad-hoc requests from reviewers
•   What are the remaining country-specific requirements to be addressed for successful marketing authorization, while ICH and EMA guidelines are acceptable in most of the ASEAN countries
•   Regulations expertise to help and direct the Asian regulatory systems to accomplish drug product registration, and way to expand Asian medical markets
•   Evaluating regulation responsibility, and dismissing the need for duplicate studies to meet diverse regulation requirements, and supporting the drug companies more time and assets that can be used towards research and development of new drugs

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

Panellists
VIJAYA ANAND, Chief Manager - Corporate Regulatory Affairs, Piramal
SAKHARAM GARALE, Head South-East Asia Operations ACMA
JITENDRA KUMAR BADJATYA, Editor-In-Chief, International Journal of Drug Regulatory Affairs
PRALHAD TAYADE, GM Formulation Development R & D, Contract Research, Raptakos, Brett & Co.

12:10 - Overview of regulation in India and CDSCO updates with specific reference to New Drug, Clinical trial, medical devices

RUBINA BOSE, Deputy Drugs Controller(India), CDSCO (WZ)

12:40 - Networking luncheon

Afternoon Chair Person

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

13:50 – Criteria to qualify as compassionate use

•   Patients suffering from life threatening diseases, or diseases causing serious permanent disability
•   No comparable or satisfactory therapy available to diagnose, monitor, or treat the patient’s disease or condition.
•   That the probable risk to the person from the investigational product is not greater than the probable risk from the disease or condition.
•   Sufficient evidence of the safety and effectiveness of the investigational product to support its use in the particular circumstance;
•   Investigational product will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval
•   The patient is unable to participate in a clinical trial.

SAKHARAM GARALE, Head South-East Asia Operations ACMA

14:20 – DISCUSSION WITH EXPERTS: Impacts and Opportunities for IP strategies in regulatory affairs – Globally & Digitally

•   What are the circumstances and influences on IP protection with the rise of digitalization, harmonization and internationalization?
•   Future conceptualization for IP strategies and its regulatory significance
•   Recognizing the diverse aspects of IP and influences by taking a regulatory strategic approach
•   IP characteristic and their impact and the influence on regulatory strategies/key issues/patents/trademarks and copyright as well as data and market exclusivity for global pharmaceutical products
•   Develop own IP policies, management style, schemes etc… depending on its area of specialty
•   Assisting the economic growth of a country by supporting healthy competition and encouraging industrial advancement and economic growth.

Moderator
SALIL SAKSENA, GMP Consultant for FDA remediation with a MNC, ProClinical

Panellists
RAHUL GUPTA, Vice President, Regulatory Affairs, USV
KEDAR SUVARNAPATHAKI, Head - Regulatory Affairs & IP, Boehringer Ingelheim
S.R.SALUNKHE, Former Assistant commissioner, FDA Maharashtra
VISHAL MHATRE, Associate Vice President - Regulatory Affairs, Tata Consultancy Services

15:10 – Afternoon Tea/Coffee

15:30 – Visions for the future – Pharma 2020

•   Growth areas for drug pipeline
•   Regulatory trends and expectation from Indian and International Regulatory Agencies
•   Market access and pricing point
•   Most significant strategy for long term sustainability
•   Areas need Industry and Regulatory Agency collaboration

RAHUL GUPTA, Vice President, Regulatory Affairs, USV

16:00 - DISCUSSION WITH EXPERTS: Leading quality manufacturer in regulated industries including food, drugs and medical devices

•   Global regulatory challenges and current hot topics in the regulatory world
•   Cooperating with the interphase of drug growth, manufacture, market and clinical research.
•   Inputting regulatory principles on the development of new product, preparation till submission to the issuing regulatory bodies of health authorities
•   Probable risks, concerns, and key points for successful adoption of electronic labelling
•   GMP regulation in Asia – Expectation, and key differences – A quality and lifecycle management
•   Regulating the safety and efficacy of products to protect the health of public
•   India’s current regulatory scenario and structure – what’s changed and what else to expect

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

Panellists
RAJENDRA SANGHAVI, Sr. Consulting Clinician & Chairman - Medical Committee, Indian Drug Manufacturers’ Association (IDMA)
MAYUR PARMAR, Deputy Collector, Government Of Gujarat
AMITA BHAVE, Head Regulatory Affairs GDD India, Novartis
RITU JOHARI, Head-Scientific Affairs, Quality & Regulatory, Abbott Diabetes Care
PRAVIN GHADGE, Head of Clinical Research Services, Reliance Life Sciences
ASHWANI PANDITA, General Manager Quality Management & Training, Global Clinical Research Operations, Glenmark Pharmaceuticals

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