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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.

Poster

Click here for a step by step guide on how to register.

Programme

Fees

Click here to find out more about the Course Fees.

Continuing Education Credits

The Centre of Regulatory Excellence is an accredited provider for Continuing Professional Education (CPE) for Pharmacists and Continuing Medical Education (CME) for Doctors.

Continuing education credits are available for CoRE events through the Singapore Pharmacy Council and the Singapore Medical Council subject to their respective approvals.

Attendees who wish to avail of the credits are required to sign the relevant registration form along with their CPE/CME number on the day of the events.

Should the event be conducted online, please provide your CPE/CME number in the respective e-registration form.

The attendee’s registration details will be submitted after the event and credited upon receiving respective approvals.

Date and Time

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

Registration

Registration is closed

Speaker

Speakers

Ms Adena Lim

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

Ms Ayn Nova Celo

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

Ms Alexandra Hoegberg

Head
Global Communications
Uppsala Monitoring Centre

Ms Christine Ho

Regulatory Consultant
Vigilance and Compliance Branch
Health Sciences Authority
Singapore

Mr Christopher Knight

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

Dr Han Phey Yen

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

Mr Hiren Thakkar

Principal
Real World Solutions, SEA
IQVIA

Dr Jean-Christophe Delumeau

Head
Pharmacovigilance Policy Strategy (Global)
Bayer

Dr Joseph Mitchell

Pharmacovigilance scientist
Uppsala monitoring Centre

Ms Mandeep Rai

Global Head
Pharmacovigilance Audits & Inspections
Kyowa Kirin

Mr Patrick Batty

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

Ms Peck Li Fung

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

Dr Ruth Savage

Senior Medical Assessor
New Zealand Pharmacovigilance Centre

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