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Day 2- Wednesday, 21st September 2016

LATEST COUNTRY PV UPDATES

09:10 AM - 09:30 AM Thailand's PV Landscape: New PV Requirements and Regulatory Updates

Wimon Suwankesawong, Head of Health Product Vigilance Center, Thailand FDA

Wimon Suwankesawong

Head of Health Product Vigilance Center
Thailand FDA

09:30 AM - 09:50 AM Indonesia's Regulatory Developments: Meeting RMP Requirements and Overcoming Future Challenges

Siti Asfijah Abdoellah, Head, Sub-Directorate of Surveillance and Risk Analysis of Therapeutic Prod, Indonesia National Agency of Drug and Food Control (NADFAC)

Siti Asfijah Abdoellah

Head, Sub-Directorate of Surveillance and Risk Analysis of Therapeutic Prod
Indonesia National Agency of Drug and Food Control (NADFAC)

09:50 AM - 10:10 AM Building an Effective, Sustainable and Pro-Active PV System in Vietnam

Nguyen Hoang Anh, Technical Vice Director, Vietnam National Centre for Drug Information and ADR Monitoring

Nguyen Hoang Anh

Technical Vice Director
Vietnam National Centre for Drug Information and ADR Monitoring

Noraisyah Mohd Sani

Head of Pharmacovigilance Section
National Pharmaceutical Regulatory Agency (NPRA), Malaysia (formerly known as National Pharmaceutical Control Bureau)

10:30 AM - 11:00 AM Morning Break & Networking


Defining role-specific goals and metrics in quality assurance
How can you track PV SOPs and update working documents in a more proactive manner?
Implementing a Quality Management System incorporating Corrective and Preventive action plans (CAPAs)
Utilizing appropriate assessment tools for evaluating drug databases: How do you validate IT systems and applications?
Exploring the role of the Qualified Person for Pharmacovigilance (QPPV) in Asia as a single point of contact


Sushrut Bhatt

Director Medical Governance Quality & Risk Management
GlaxoSmithKline Pharmaceuticals Limited

Byron Webb

Local Safety Responsible
Roche, (Philippines) Inc.

11:45 AM - 12:15 PM Post-Marketing Surveillance on Biosimilars in India: A Case Study on Collaborative Methods in Risk Minimization

Deepa Arora, ‎Vice President- Pharmacovigilance & Global Head, Lupin
Collaboration of Industry and India’s National Programs to create a robust risk minimization system
Understanding guidelines towards a specific type of product; Anti-tuberculosis and anti-hypertension as examples
How can the risks of ADR be managed across different populations and ethnicities?
Evaluating the effectiveness of educational programmes and controlled access


Deepa Arora

‎Vice President- Pharmacovigilance & Global Head
Lupin

12:15 PM - 1:15 PM Lunch


1:15 PM - 2:15 PM INTERACTIVE GROUP DISCUSSION: Industry Applications: Staying Competitive While Ensuring Regulatory Compliance

During this part of the summit, delegates will take
part in interactive discussions on the topic of their
choice. Groups are kept small to facilitate more
intimate discussions. After a period of 45 minutes,
there will be a summary sharing from each table

Table A

1:15 PM - 2:15 PM Table A: Negotiating the Australia-Specific Annex and Adopting EU RMPs

Minhaj Obeidullah, Regional Head Pharmacovigilance Oversight - APAC, Sandoz

Minhaj Obeidullah

Regional Head Pharmacovigilance Oversight - APAC
Sandoz

Table B

1:15 PM - 2:15 PM Table B: Japan’s Latest Developments on Compliance in Post-Marketing Studies and RMPs

E Stewart Geary, Chief Medical Officer, Vice President and General Manager, Eisai Co., Ltd.

E Stewart Geary

Chief Medical Officer, Vice President and General Manager
Eisai Co., Ltd.

Table C

1:15 PM - 2:15 PM Table C: Re-Positioning PV as Part of Corporate Risk Management plus an Update on New Labelling Laws

Byron Webb, Local Safety Responsible, Roche, (Philippines) Inc.

Byron Webb

Local Safety Responsible
Roche, (Philippines) Inc.

2:15 PM - 2:45 PM The Future of Virtual Clinical Trial Models: Global Developments and Applications


Overcoming challenges in regulatory compliance, patient enrollment and obtaining management buy-in
Examining current performance metrics: how do you ensure data quality and consistency?
Future iterations, scalability and global applications of the Electronic Informed Consent (EIC) model
Creating trust and facilitating relationships virtually between participants and staff for successful recruitment
Developments in patient support through tablet communication devices and call centers


2:45 PM - 3:15 PM Afternoon tea break


3:15 PM - 3:45 PM A Novel Approach: Oversight of PV Systems on a Global Scale

Sushrut Bhatt, Director Medical Governance Quality & Risk Management, GlaxoSmithKline Pharmaceuticals Limited
  • Key updates on an ongoing 2-year global project to establish qualified PV affiliates
  • How do you ensure visibility and maintain quality in an MNC with more than 100 offices across the world
  • Establishing an in-house standardised monitoring system with scalable heatmap
  • Change management and integrating a global PV system into the company corporate quality system
  • Ensuring clear metrics with agreed definitions and methodology

Sushrut Bhatt

Director Medical Governance Quality & Risk Management
GlaxoSmithKline Pharmaceuticals Limited

3:45 PM - 4:15 PM Exploring Long-Term Strategies in Developing Core PV Processes: Outsourcing vs. Capacity Building

Jessica Thongcharen, Associate Director, Global Pharmacovigilance Operations,, Takeda Global Research & Development Center Asia Private Limited

Discussing Asia’s strategic shift from outsourcing to innovation in research and development
Discovering opportunities and overcoming obstacles in building core PV processes in various parts of Asia.
When is it more justifiable to internalize PV functions?
Ensuring smooth transitions: how and when should one re-integrate outsourced functions into the company?


Jessica Thongcharen

Associate Director, Global Pharmacovigilance Operations,
Takeda Global Research & Development Center Asia Private Limited
Merger and acquisitions are increasingly on the rise in the pharmaceutical and bio-technology industry. Done out of financial or business reasons, PV is often considered as afterthought and may be addressed late in negotiations on post-conclusions, at the risk of compliance or safety:
How do you overcome operational challenges and manage the switch in ownership?
Ensuring safety systems continue uninterrupted and that PV functions are carried out in a timely manner
The role of the QPPV in ensuring a clear transition of responsibilities and the maintenance of activities
How is compliance assured across multiple databases?
Determining that all safety exchange agreements in place and valid


Rie Matsui

Director, Regional Labeling Head for Asia
Pfizer

Jean Christophe Delumeau

Head of Pharmacovigilance Asia Pacific & China
Bayer South-East Asia (Singapore)

Jessica Thongcharen

Associate Director, Global Pharmacovigilance Operations,
Takeda Global Research & Development Center Asia Private Limited