20th Pharmacovigilance 2019

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

09:20 – Chairperson opening remarks

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

MARKET OVERVIEW & ANALYSIS

09:30 – Pharmacovigilance Perceptions : Protection of Patients

ARUN BHATT, Consultant – Clinical Research & Development

10:00 – ‘Improving effectiveness and compliance of literature screening – Automation, prioritization and outsourcing’.

JEAN-DOMINIQUE, Subject Matter Expert - Pharmacovigilance and Drug Safety, Elsevier (France)

10:30 – Morning Coffee/Tea & Discussion

CHALLENGES & OPPORTUNITIES

10:50 – DISCUSSION WITH EXPERTS: Discussing on the global pharmacovigilance system for India

•   Recent development of pharmacovigilance system in India
•   Rising pharmacovigilance issues & business models
•   Automating pharmacovigilance processes: Are we already for the upcoming future?
•   Improving patient safety and creating crucial awareness to enhance for better clinical practice
•   Challenges and process of adverse drug reaction reporting system in India
•   How digital transformation and AI can impact pharmacovigilance
•   Challenges to implement rules and regulation related to pharmacovigilance program in India and can it be avoided

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

Panellists
UJWALA NAIK, Country Head-Pharmacovigilance, Johnson & Johnson
ROSHAN PALEWAR, CEO, Pharma Global Leader, DocRoShGlobal Solutions
SRIRUPA DAS, Director - Medical Affairs, Abbott
MANOJ SWAMINATHAN, Chief Manager Head Global Pharmacovigilance Center, Piramal
DHANARAJ E, Pharmacovigilance Lead, Biocon

11:40 – DISCUSSION WITH EXPERTS: Ensure safe use of medicines and minimizing the risks related to the medicinal product

•   Data generated during clinical trials to provide information about the common adverse events
•   Monitor safety during the post-approval period and through out the entire lifecycle of the medicinal product
•   Implementing risk management programs by data mining pharmacovigilance safety databases and signal detection
•   CDER and FDA: Highlighting the depth and versatility of drug safety initiatives
•   Developing drug safety reporting platform that automates complex processes to ensure compliance in the regulatory environment
•   Monitoring safety reporting and agreements – what needs to be covered? And what happens if it goes wrong?

Moderator
PRASHANT BODHE, Director, CliniSearch

Panellists
OMPRAKASH S. SADHWANI, Former Joint Commissioner and controlling Authority, Food and Drug Administration (Maharashtra state)
DEEPA ARORA, Director, CLINEXEL Life Sciences
ARUN BHATT, Consultant – Clinical Research & Development
PRADEEPA RAMAKRISHNA, Global Safety Physician Lead Surveillance Physician, AstraZeneca
ANANT PATIL, Asst Professor Department of Pharmacology, Dr DY Patil Medical College
KAVYA KADAM, Consultant Global Clinical Trials

12:30 - Networking luncheon

Afternoon Chair Person

PRASHANT BODHE, Director, CliniSearch

13:50 – Pharmacovigilance of biosimilars

DEEPA ARORA, Director, CLINEXEL Life Sciences

14:20 – DISCUSSION WITH EXPERTS: Real-world example of the development of a successful risk management plan

•   Essential risk management plans from an industry point of view
•   How to write a successful risk management plan
•   Necessary aspects of managing biopharmaceutical product risks and benefits in health care delivery system
•   Reporting results of outcomes of activities in the risk management plan
•   The regulatory framework for pharmacovigilance in the context of risk management planning
•   Stimulating pharma and drug industry for pharmacovigilance practice and software’s to use in pharmacovigilance and clinical trials.
•   Risk based strategies for safety issues in immuno-oncology
•   Updating risk management plan

Moderator
PRANJAL BORDOLOI,Vice President Clinical Medical Affairs & Pharmacovigilance,Veeda Clinical Research

Panellists
INDU NAMBIAR, Head Pharmacovigilance, Boehringer Ingelheim
CHIRAG TELI, Head of Medical Services, Alkem Laboratories
PRAVIN GHADGE, Head of Clinical Research Services, Reliance Life Sciences
SAKHARAM GARALE, Head South-East Asia Operations ACMA & Managing Partner, RENOVARE Healthcare Solutions
CHAITANYA KULKARNI, Manager Pharmacovigilance, Brillpharma (Subsidiary of Bristol Labs,UK)
UJWALA V. SALVI, Founder & Chief Executive Officer, Nucleon Therapeutics

15:10 – Afternoon Tea/Coffee

REGULATORY

15:30 – The current regulatory framework and its global impact

SHIVANI ACHARYA, Associate Director – Clinical Development & Pharmacovigilance, Abbott

16:00 – DISCUSSION WITH EXPERTS: Understanding the global regulatory developments and updates

•   New pharmacovigilance guidance in India: Expectation that can significantly change the pharmaceutical safety landscape
•   Explaining principles and guidelines for planning and preparing responses to inspection observations
•   Plan and conduct a response to inspect observe, including development of a CAPA, measurement, and tracking
•   Addressing progression on global harmonization of pragmatic safety requirements
•   Regulatory perspective on machine learning in pharmacovigilance
•   Challenges in new regulatory policy and development of diagnostic products that combine drugs, devices and biological products
•   Emerging pharmacovigilance regulations in emerging markets
•   Regulatory trends in clinical safety & pharmacovigilance
•   New regulatory policy, development, and review

Moderator
VISHWAS SOVANI, Founder Director, Pharmawisdom

Panellists
KAMAL K HALDER, ADCI, CDSCO (WZ)
RAHUL GUPTA, Vice President, Regulatory Affairs, USV
SHIVANI ACHARYA, Associate Director – Clinical Development & Pharmacovigilance, Abbott
KARTHIK BABU, Multi Country Safety Head-South Asia, Sanofi
SOFI JOSEPH, Head of Regulatory Affairs and Pharmacovigilance, Serdia Pharmaceuticals
PAVAN BADALE, Head PV Process Excellence Safety case Management, Novartis

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