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2021 GMS5115 Principles and Frameworks for Pharmacovigilance (Conducted Remotely)

Pharmacovigilance is one of the key regulatory functions, and monitors the safe effective use of pharmaceuticals in the real-world healthcare setting. It drives the source of real-world evidence that feedbacks into the regulatory decision-making process, contributes to timely post-approval actions and completes the product life cycle management. This 4-credit module introduces the principles of pharmacovigilance, regional and global frameworks, as well as the pivotal processes involved in optimal data collection, collation and signal generation. The need for partnership among regulatory stakeholders is a focus as this is critical in ensuring adequate quality data that is the stem of pharmacovigilance.

Due to the limited availability of seats, early registration is strongly recommended.
 
 




Date and Time

11 Oct 2021 @ 08:30 - 15 Oct 2021 @ 17:30

Registration

Registration is closed

Speaker

 Speakers

Adena Lim_2019

Ms Adena Lim

Deputy Director
Vigilance and Compliance Branch
Health Sciences Authority (HSA), Singapore

Ayn

Ms Ayn Nova Celo

Patient Safety Head (Singapore, Myanmar, Vietnam)
Novartis Asia Pacific Pharmaceuticals Pte Ltd

Alexandra Hoegberg

Ms Alexandra Hoegberg

Head
Global Communications
Uppsala Monitoring Centre

Christine Ho

Ms Christine Ho

Regulatory Consultant 
Vigilance and Compliance Branch 
Health Sciences Authority 
Singapore


Christopher Knight

Mr Christopher Knight

Founder
Alliance for Safe Medicine Asia
Everett Knight (Asia Pacific) Pte. Ltd.

Han Phey Yen

Dr Han Phey Yen

Senior Regulatory Specialist
Vigilance and Compliance Branch
Health Sciences Authority (HSA) Singapore 

Hiren Thakkar

Mr Hiren Thakkar

Principal
Real World Solutions, SEA
IQVIA

Jean-Christophe_Delumeau_2-removebg-preview

Dr Jean-Christophe Delumeau 

Head
Pharmacovigilance Policy Strategy (Global)
Bayer 

Joseph Mitchell

Dr Joseph Mitchell

Pharmacovigilance scientist 
Uppsala monitoring Centre

Mandeep Raj

Ms Mandeep Rai

Global Head
Pharmacovigilance Audits & Inspections 
Kyowa Kirin

Patrick Batty

Mr Patrick Batty

UK Alternate delegate
EU Pharmacovigilance Risk Assessment Committee (PRAC)
Vigilance and Risk Management of Medicines,
UK MHRA

Peck Li Fung

Ms Peck Li Fung

Senior Regulatory Specialist
Vigilance and Compliance Branch
Health Sciences Authority (HSA) Singapore

Ruth Savage

Dr Ruth Savage 

Senior Medical Assessor 
New Zealand Pharmacovigilance Centre 

Senior Lecturer 
Dept of General Practice 
University of Otago
Christchurch, New Zealand