In collaboration with Accestra Consulting. we invite you to join us for a series of four complimentary webinars in the first 2 weeks of April 2022.
Introduction to Generic Drug Registration in Malaysia, Singapore, Vietnam and China
The generic drug registration webinars will cover these topics for each country:
- Regulatory Framework and Pathways
- Registration process and their timelines
- Registration dossier format and document language needed
- Bioequivalence and/or Clinical Study: Exemption & Requirements
- Key Takeaways & Tips
Registration of Drug Master File (DMF) in China for APIs, Excipients & Packaging Materials
The China DMF registration webinar will cover these topics:
- China DMF Regulatory Framework
- China DMF Pathways
- Comparison between China DMF, US DMF, EU CEP and ASMF
- China DMF requirements and timelines
- Tips & Pitfalls
Introduction to
Generic Drug Registration
in Malaysia
Date:
5 April 2022, Tuesday
Time:
16:00 – 17:00 Malaysia/China
18:00 – 19:00 Sydney
04:00 – 05:00 EST
10:00 – 11:00 CET
Introduction to
Generic Drug Registration
in Vietnam & Singapore
Date:
6 April 2022, Wednesday
Time:
16:00 – 17:00 Singapore/China
18:00 – 19:00 Sydney
04:00 – 05:00 EST
10:00 – 11:00 CET
Please register separately for each webinar that you would like to attend
Introduction to
Generic Drug (ANDA)
Registration in China
Date:
7 April 2022, Thursday
Time:
16:00 – 17:00 China
18:00 – 19:00 Sydney
04:00 – 05:00 EST
10:00 – 11:00 CET
Registration of DMF for APIs,
Excipients & Packaging
Materials in China
Date:
13 April 2022, Wednesday
Time:
17:00 – 18:00 China
19:00 – 20:00 Sydney
05:00 – 06:00 EST
11:00 – 12:00 CET
Please register separately for each webinar that you would like to attend
See you there!
– Accestra Events Team
