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Day 1 - Tuesday, 20th September 2016

09:10 AM - 09:50 AM Risk Management Plans (RMP) : Examining European PV Legislation

Herve Le Louet, Member for the European Commission of the Pharmacovigilance Risk Assessment, European Medicines Agency
Obtaining approval for Risk Management Plans and Risk Minimisation Plans
Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)


Herve Le Louet

Member for the European Commission of the Pharmacovigilance Risk Assessment
European Medicines Agency

How do companies ensure alignment of local, mandated RMPs with global RMPs?
How can APAC countries implement globally mandated risk mitigation actions, especially when this may affect their business locally?
Addressing key challenges on complying with local RMP’s


Jean Christophe Delumeau

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

Nguyen Hoang Anh

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

Siti Asfijah Abdoellah

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

Minhaj Obeidullah

Regional Head Pharmacovigilance Oversight - APAC
Sandoz

Wimon Suwankesawong

Head of Health Product Vigilance Center
Thailand FDA

10:40 AM - 11:20 AM Morning Break



Since the 2015 International Society of Pharmacovigilance (ISoP)’s Prague meeting, the newly formed Special Interest Group is venturing into designing novel methods suitable for a large array of health care systems. Gain firsthand insights on the Post-Approval Vigilance Program (PAVP) concept. Hear from the relevant authorities on the latest progress and operational aspects of these customizable methods that are highly scalable, flexible and Risk-adjusted. Discover how this new programme addresses the diverse needs of non-ICH Asian countries and strategies on overcoming the reluctance of healthcare professionals in reporting suspected ADRs.


Herve Le Louet

Member for the European Commission of the Pharmacovigilance Risk Assessment
European Medicines Agency

Jean Christophe Delumeau

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

12:00 PM - 1:00 PM Lunch


1:00 PM - 2:00 PM Interactive Discussion Groups: Practical Approaches in Implementing and Maintaining Good Vigilance Practices (GVP)


Table A

1:00 PM - 2:00 PM Roundtable A: Negotiating PV Timelines: Closing the Gap between Company SOP and Local Regulation

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

Jessica Thongcharen

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

Table C

1:00 PM - 2:00 PM Evaluating the Effectiveness of Your Existing Risk Minimization Methods

Christine Chandran, Country Safety Team Lead, Johnson & Johnson

Christine Chandran

Country Safety Team Lead
Johnson & Johnson

Table D

1:00 PM - 2:00 PM Roundtable C: Simplifying Risk Management Plans for Non-ICH Developing Nations

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

Byron Webb

Local Safety Responsible
Roche, (Philippines) Inc.

2:00 PM - 3:00 PM Hands-On Evaluation Session: Leveraging Mobile Apps for Medication Adherence in Pharmacovigilanc

Kevin Yap, Professor, Lecturer, National University of Singapore
During the first part of the session, Dr Yap will first explain the importance of medication adherence in patient safety and strategies to systematically assess existing digital health applications. This will be followed by a practical session where delegates will get to apply the concepts learnt via a hands-on exercise. The results of the mobile application evaluation will be analyzed and released on Day 2 during lunchtime. The following questions will be discussed:

How do you choose a set of evaluation criteria that best fit your needs:
Generic vs. specific
Demographic profile vs. therapeutic area
What are the features that clinicians and patients look out for in apps and drug databases?
Exploring effective change management strategies


Kevin Yap

Professor, Lecturer
National University of Singapore

3:00 PM - 3:30 PM Afternoon tea break


3:30 PM - 4:00 PM Strategic Collaboration with Industry Partners: Integrating Digital Health Initiatives to Minimise Risks and Enhance Patient Safety

Christine Chandran, Country Safety Team Lead, Johnson & Johnson
Enhancing efficiency and accuracy in Adverse Event Reporting while meeting requirements
Tailoring digital application features in accordance to specific therapeutic areas
Aligning with the needs of healthcare providers and hospital management through close collaboration
Ensuring interoperability with information systems


Christine Chandran

Country Safety Team Lead
Johnson & Johnson

4:00 PM - 4:30 PM Safety Labeling in Asia: Communicating Risks Effectively

Rie Matsui, Director, Regional Labeling Head for Asia, Pfizer

How do you make efficient and cost-effective revisions to packaging inserts? How do you design it with the healthcare provider or patient in mind? Moreover, with increased availability of drug information online in the US and Europe, discover how Asia is catching up - with Japan, Korea and Taiwan leading the way in the virtual communication of safety information.
Designing user-friendly package inserts for healthcare providers and patients to make better-informed decisions
Mitigating off-label use and identifying risk information for RMPs
Overcoming challenges faced in revision of packaging inserts across languages and cultures
Aligning global safety labeling requirements with local package insert policies
Exploring the benefits and risks of e-labeling


Rie Matsui

Director, Regional Labeling Head for Asia
Pfizer

4:30 PM - 11:59 PM Panel Discussion: Ensuring Compliance in Patient Support Programmes (PSP): Leveraging Multi-Stakeholder Collaboration to Enhance Data Capture

Deepa Arora, ‎Vice President- Pharmacovigilance & Global Head, Lupin E Stewart Geary, Chief Medical Officer, Vice President and General Manager, Eisai Co., Ltd. Minhaj Obeidullah, Regional Head Pharmacovigilance Oversight - APAC, Sandoz

How do you realistically ensure patient adherence and prevent off-label use with the assistance of digital technologies?
Interfacing both local and global markets research programmes to maximize data collection
Effectively capturing all opportunities of patient interaction with pharmacists and healthcare providers to improve systematic inputs of information
Ensuring quality standards in conduct of PSPs and Market Research Programmes (MRPs) in real-time


Deepa Arora

‎Vice President- Pharmacovigilance & Global Head
Lupin

E Stewart Geary

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

Minhaj Obeidullah

Regional Head Pharmacovigilance Oversight - APAC
Sandoz