The webinar aims to provide an overview of the regulatory landscape for generic drug registration in Singapore. It will allow listeners to be able to have some basic understanding of the regulatory requirements for generic drug registration in Singapore so as to enable them to prepare for their regulatory filing better. In the session, there will be some helpful tips and references that attendees could take away successfully from this session.
Contents
- Overview of the regulatory landscape in Singapore
- Definition of generic drug in Singapore
- Type of patent
- Type of application and evaluation pathway
- Official timelines and fees to be collected
- Requirements for Module 1 document
- Requirements for Module 2 document
- Requirements for Module 3.2.S drug substance
- Requirements for Module 3.2.P drug product
- Requirements for Module 3.2.R product interchangeability
- Regulatory review process and what to expect
- Tips for successful submission
- Useful References
Schedule
| Date | Time (GMT +8) | World Clock | Language |
| 2023-04-06 | 21:00 ~ 22:00 | London: 14:00-15:00 New York: 9:00-10:00 |
English |
Speaker
Verlene Law
Regulatory Consultant and Director
Ms. Verlene Law is an experienced regulatory affairs expert versatile in managing regulatory submissions for both therapeutic products and medical devices across different therapeutic areas in ASEAN. Her working experiences in both MNCs and SMEs have equipped her with various skills such as negotiation, presentation, project management, and problem-solving skills to support companies in managing their product lifecycle management for both pre-submission and post-submission activities. She is a quick-witted person that is approachable, possesses excellent communication skills, and is easy to work with.