2023 GMS5116 Post-Market Activities for Pharmaceuticals

The assurance of safe and quality medicines in the market depends on a range of vital activities after the approval of a medicine by the authorities. This includes the continual monitoring offered by inspections and audits of facilities and testing of product quality. In this globalised environment, there is also an increasing need to leverage on networks to effectively detect lapses in product quality and services in a timely manner.

This course introduces the key activities and roles essential for effective post-market control, including management of failures of conformance and compliance. Topics covered will include collaborations and networks for optimising post-market communications, and handling of substandard and falsified pharmaceuticals.

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


Date and Time

25 Sep 2023 @ 08:30 - 29 Sep 2023 @ 17:30



James Leong

Asst Prof James Leong

Head, Health Products
and Regulatory Science
Centre of Regulatory Excellence (CoRE)
Duke-NUS Medical School

Teo Jing Yi

Ms Teo Jing Yi

CMC Regulations
MSD Singapore

Sachdeva Vimal

Mr Vimal Sachdeva

Technical Officer – Senior Inspector
Inspection Services Group,
Prequalification Team (PQT)
World Health Organization (WHO)


Dr Stephen Hsu

Regional Head
Quality Assurance
Alcon, Singapore


Mr Brett Marshall

Vice President – Quality & HSSE
Zuellig Pharma Holdings Pte Ltd

Cathleen E. Afable

Ms Cathleen E. Afable

Regional Director, International Markets
Cell Therapy Operations, Novartis

Cathleen E. Afable

Ms Yang Silin

Senior Regulatory Specialist
Vigilance and Compliance Branch (VCB)
Health Products Regulation Group (HPRG)
Health Sciences Authority (HSA)

Cathleen E. Afable

Mr Choong Chih Tzer

Senior Regulatory Specialist
HSA, Singapore

Ruth Lee

Ms Ruth Lee

Associate Director
Public Policy and Regulatory Affairs
Global External Affairs, APAC
United States Pharmacopeial
Convention (USP)

Ramesh Raj

Mr Ramesh Raj Kishore

Regional Director – Asia Pacific
Pharmaceutical Security Institute

Ramesh Raj

Associate Prof. Sunil Tiwari

ESSCA School of Management