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2020 GMS5105 Generic Medicines (Conducted Remotely)

In view of the COVID-19 situation and the local measures to further contain the spread, GMS5105 Generic Medicines (13 to 17 July 2020) will be conducted remotely.

The workshop programmes has been re-arranged to accommodate the logistics involved. Students will require a laptop or computer with a video camera and internet access for the duration of the workshop.

We seek your kind understanding on the necessary changes to deliver the same quality of our programmes to you, and your continued support to CoRE and measures to counter COVID19. Should you have any queries, kindly contact us at CoRE_Education@duke-nus.edu.sg



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). 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.
 
 
 


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

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Date and Time


13 Jul 2020 @ 09:00 - 17 Jul 2020 @ 18:00

Registration


Registration is closed

Speaker


Henrike Potthast

Dr Henrike Potthast

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

Jan Welink

Dr Jan Welink

Chair
Pharmacokinetics Working Party
European Medicines Agency
Senior Clinical Assessor
Medicines Evaluation Board (MEB)

jinshun

Dr Jin Shun

Head
Regulatory Affairs
APMA
Sandoz

lakshmana Murthy

Dr Lakshmana Murthy

Director
Quality Assurance
United States Pharmacopeia (USP)
India

Leanne Cornell - photo

Ms Leanne Cornell

Senior Evaluator
Pharmaceutical Chemistry Section
Scientific Evaluation Branch
Therapeutic Goods Administration
Australia

Michael Harding

Mr Michael Harding

Principal Evaluator
Pharmaceutical Chemistry Section
Scientific Evaluation Branch
Therapeutic Goods Administration
Australia

sharad mankumare

Dr Sharad Mankumare

Director
RSL and Verification Programs
The United States Pharmacopeia (USP)
India

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Dr Stefanie Amend-Mall

Head
Global Project Management Office
PD (Product Development)
Sandoz

Wenji Ji


Ms Wenjie Ji

Departmental Officer
Pharmaceutical Chemistry Section
Scientific Evaluation Branch
Medicines Regulation Division