7th Annual Pharmacovigilance Asia Summit Follow Verify

http://www.pharmacovigilanceasia.com/
7th Annual Pharmacovigilance Asia Summit
Related Certifications	Certificate in Current Pharmacovigilance Regulatory Landscape

The 7th Pharmacovigilance Asia Summit will gather global and regional regulators from EMA, Indonesia, Thailand, Australia, Japan & Singapore, together with industry experts from pharmaceutical, biotech and medical device companies to discuss strategies on prioritizing compliance and quality through digital technology and collaboration and answer important questions related to PV.

What are the new quantitative methods in benefit-risk evaluation? How do you create a PV-focused culture and what is the role of the Qualified Person for Pharmacovigilance (QPPV) in Asia? How has digital health initiatives impacted the cost and accuracy of PV? How do you leverage mobile applications to enhance medication adherence and patient support compliance?

Key Topics To Be Addressed in 2016 Include:

The latest PV legislation – how will developments in US and Europe affect Asia? Leveraging digital health applications to enhance patient support through detecting and managing safety signals and enhance patient support Pro-actively negotiating risk management plans and benefit-risk evaluation in Asia – both quantitative and qualitative approaches Creating a PV-focused culture and ensuring quality assurance across people, process and technologies Ensuring continuity and compliance in MandA environment How to effectively communicate risk through education, awareness, and collaboration with the community.

Speaker Highlights

Herve Le Louet

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

Mr. Louet will be speaking at the Risk Management Plans (RMP) (Examining European PV Legislation) session about obtaining approval for risk management plans and risk minimisation plans and highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) and at Updates from International Society of Pharmacovigilance (ISoP)’s special interest group on risk minimization methods for Asia session about the latest progress and operational aspects of these customizable methods which are suitable for a large array of health care systems and how this new programme addresses different needs of non-ICH Asian countries and strategies on overcoming the unwillingness of healthcare professionals in reporting suspected ADRs.

Christine Chandran Country Safety Team Lead, Johnson & Johnson Singapore

Miguel Orri Chairman, eClinicalHealth Advisory Board UK and Managing Director, InnovatOrri Pharma Consulting

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

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

Wimon Suwankesawong Head of Health Product Vigilance Center, Thailand Food and Drug Administration

Noraisyah Mohd Sani

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

Mrs. Noraisyah Mohd Sani will take a part in panel discussion Discussing country-specific annexes to be implemented in 2016 for RMP. The session will look at the latest research on how do companies ensure alignment of local, mandated RMPs with global RMPs and how could APAC countries implement globally mandated risk mitigation actions, especially when this may affect their business locally and key challenges on complying with local RMP’s. Mrs. Sani will be speaking also at Building an Effective, Sustainable and Pro-Active PV System in Vietnam session.

Nguyen Hoang Anh

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

Minhaj Obeidullah

• Regional Head Pharmacovigilance Oversight - APAC
• Sandoz, European Medicines Agency

Jean Christophe Delumeau

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

E Stewart Geary

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

Rie Matsui

• Director, Regional Labeling Head for Asia
• Pfizer

Sushrut Bhatt

• Director Medical Governance Quality & Risk Management
• GlaxoSmithKline Pharmaceuticals Limited

Miguel Orri

• Managing Director
• InnovatOrri Pharma Consulting

Jamal Baig

• Associate Director of Pharmacovigilance
• Merck Sharp And Dohme (MSD)

Kevin Yap

• Professor, Lecturer
• National University of Singapore

Byron Webb

• Local Safety Responsible
• Roche, (Philippines) Inc.

Deepa Arora

• ‎Vice President- Pharmacovigilance & Global Head
• Lupin

Jessica Thongcharen

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

Christine Chandran

• Country Safety Team Lead
• Johnson & Johnson

Wimon Suwankesawong

• Head of Health Product Vigilance Center
• Thailand FDA

Siti Asfijah Abdoellah

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

Agenda

Pre-Conference Workshop - Monday, 19th September 2016 Workshop A

9:00 AM Good Pharmacovigilance Practices (GVP) Overview and Implementation

• Implementation of GVP
• Preparing and maintaining Pharmacovigilance System Master Files
• Reporting of adverse drug reactions – criteria, SOPs, and roles of stakeholders
• Update of PBRERs, Risk Management Plans and Post-Authorisation Safety Studies (PASS) requirements
• How to successfully and proactively pass inspections and audits

Speaker:

Deepa Arora - ‎Vice President - Pharmacovigilance & Global Head (Lupin)

Workshop C

1:00 PM A Life Cycle Approach to Writing Periodic Benefit-Risk Evaluation Reports (PBRERs)

• Adherence to Pharmacovigilance Risk Assessment Committee guidelines
• Understanding rationale, format and content for writing PSURs/PBRERs
• Developing a “Benefit Maximisation Plan” toolbox for approved medicines
• Reporting, evaluating and summarising safety data and signals
• Incorporating communication within and across agencies to patient support programmes (PSP)
• Collating patient and healthcare provider inputs from various social and digital channels
• Managing variations in safety restrictions, license suspension and withdrawal

Speaker:

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

Day 1 - Tuesday, 20th September 2016

9:10 AM Risk Management Plans (RMP) : Examining European PV Legislation

• Obtaining approval for Risk Management Plans and Risk Minimisation Plans
• Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)

Speaker:

Herve Le Louet - Member for the European Commission of the Pharmacovigilance Risk Assessment (European Medicines Agency)

9:50 AM Panel Discussion: Discussing country-specific annexes to be implemented in 2016 for RMP

• 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

Speakers:

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

Wimon Suwankesawong - Head of Health Product Vigilance Center - (Thailand FDA)

Nguyen Hoang Anh - Technical Vice Director (Vietnam National Centre for Drug Information and ADR Monitoring)

11:20 AM Updates from ISoP’s Special Interest Group on Risk Minimization Methods for Asia

Speakers:

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))

Day 2- Wednesday, 21st September 2016

LATEST COUNTRY PV UPDATES

9:10 AM Thailand's PV Landscape: New PV Requirements and Regulatory Updates

Wimon Suwankesawong - Head of Health Product Vigilance Center (Thailand FDA)

9:30 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 Products (Indonesia National Agency of Drug and Food Control (NADFAC))

9:50 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)

10:10 AM Regulatory Updates from Malaysia- Latest Developments and Challenges

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

11:00 AM Creating a Culture of Quality in People, Process and Technology within your PV System

• 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

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

Sushrut Bhatt - Director Medical Governance Quality & Risk Management (GlaxoSmithKline Pharmaceuticals Limited)

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

• 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)

1:15 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.

2:15 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

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

• 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 Exploring Long-Term Strategies in Developing Core PV Processes: Outsourcing vs. Capacity Building

• 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)

4:15 PM Mergers and Acquisition of PV Functions: How Do You Ensure Compliance is not Compromised?

Merger and acquisitions are increasingly on the rise in the pharmaceutical and biotechnology 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

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

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

Rie Matsui - Director, Regional Labeling Head for Asia (Pfizer)

Post-Conference Workshop - Thursday, 22nd September

Workshop B

9:00 AM Leveraging Databases and Technology for the Detection and Management of Safety Signals Data-mining during all stages of drug development: from drug discovery to best practices in post-marketing surveillance

• Converting ICSRs into structured formats and evaluating if a signal should be investigated
• Examining aggregate reports periodically to identify signals not detected from individual data
• Revising your safety monitoring practices to changing regulatory standards
• Compare and contrast existing PV databases: how can you ensure quality?
• Bulleted list item

Jamal Baig - Associate Director of Pharmacovigilance (Merck Sharp And Dohme (MSD))

References

Top Authors

• Priyadarsini
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