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2022 GMS5007 Regulation of Generic Medicines (Conducted Remotely)

Generic medicines are becoming increasingly important as a means of providing access to affordable healthcare by helping to suppress rising healthcare costs. This module aims to equip students with skills to assess the therapeutic equivalence of a generic medicinal product relative to a comparator, specifically with respect to bioavailability (BA) and bioequivalence (BE).

In this module, students will learn how to design and conduct appropriate bioavailability and bioequivalence studies in accordance with established international guidance documents, and to analyse the data from such studies.

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

Participants can claim 20 CPE points upon completion of each module.

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

09 May 2022 @ 08:30 - 13 May 2022 @ 17:30

Registration

Registration is closed due to full capacity, click here to be placed on the waitlist

Speaker

Dr Stefanie Amend-Mall

Global Program Lead, CN and APAC
Sandoz Small Molecules Product Development
Sandoz

Ms Leanne Cornell

Senior Evaluator
Pharmaceutical Chemistry Section
Scientific Evaluation Branch
Medicines Regulation Division
Therapeutic Goods Administration (TGA), Australia

Dr Michael Harding

Principal Evaluator
Pharmaceutical Chemistry Section
Scientific Evaluation Branch
Medicines Regulation Division
Therapeutic Goods Administration (TGA), Australia

Ms Ji Wenjie

Pharmaceutical Chemistry Section
Scientific Evaluation Branch
Medicines Regulation Division
Therapeutic Goods Administration (TGA), Australia

Mr Jin Shun

Head, Regulatory Affairs APMA
Sandoz

Dr Henrike Potthast

Biopharmaceutics Expert Pharmacokinetics
Federal Institute for Drugs and Medical Devices (BfArM) Germany

Dr Krishna Prasad

Associate Director
Global Regulatory Affairs
Abbott

Dr Darika Sowana

GMP Technical Lead
Regulatory Strengthening and Support Section
Indo-Pacific Regulatory Strengthening Regulatory Support & Safety Monitoring
Therapeutic Goods Administration (TGA), Australia

Ms Tan Mui Kiat

Principal Assistant Director
Prescription Unit
Centre for Product Evaluation and Cosmetic
National Pharmaceutical Regulatory Agency (NPRA), Malaysia

Dr Jan Welink

Senior Clinical Assessor
Dutch Medicines Evaluation Board (MEB), Netherlands