The purpose of the webinar is 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 on 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 useful tips and references that attendees could take away successfully from this session.
Background
Contents
Overview of 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
Speakers
Ms Verlene Law is an experienced regulatory affairs expert versatile in managing regulatory submission for both therapeutic products and medical devices across a different therapeutic areas in ASEAN. Her working experiences in both MNCs and SMEs has 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, possess excellent communication skills and easy to work with.
Contact
If you have any question about this webinar, please contact us:
+86 (0)571 8710 3829
contact@chemlinked.com
