We are delighted to see your interest in Freyr’s Webinar Series (FWS). The webinar on, “The Regulatory Pathway for Expedited Access to Malaysian Pharma Industry,” is scheduled on June 23, 2021, for AMR, EUA & ROW regions.
What Is It All About?
Malaysia is one of the top pharma markets in the Southeast Asia region. With the increasing population and awareness, the demand for pharmaceuticals is scaling on a bigger level. The efforts being made by the Malaysian government are captivating foreign investors. Efforts like tax exemptions for pharma stakeholders make Malaysia a potential market for medicinal products. The National Pharmaceutical Regulatory Agency (NPRA) acts as the secretariat to the Authority. NPRA follows strict mandates and competent Regulatory knowledge that assure significant benefits.
To give you a clear-cut insight about the Malaysian pharma market, Freyr brings you an exclusive webinar on:
The Regulatory Pathway for Expedited Access to
Malaysian Pharma Industry
June 23, 2021
Duration - 45 Minutes
Join the Webinar at your Convenient Time
Malaysian Regulatory Expert
Associate Director RA – Malaysia
Zulkhurnain Utar is a Regulatory Subject Matter Expert with more than 15 years of expertise in regional Regulatory affairs and solutions for regulated industries including medical devices/pharmaceuticals/consumer products. He has extensive experience in R&D particularly in safety and preclinical toxicology. Zulk is competent and knowledgeable in cGMP, FDA’s Quality Systems Regulations, EU Medical Device Regulations (MDR 2017/745 & IVDR 2017/746, MDD 93/42/EEC), QMS ISO 13485, ISO 14971 Medical Devices Risk Management, Conformity Assessment & CE Marking, Biocompatibility Testing ISO 10993, HACCP, and Codex Alimentarius for food, Good Clinical Practice (GCP) and GHS for chemicals.
Program Manager, Client Services
Hiteshri Choksi, Program Manager at Freyr, has been in the life sciences industry for around five (5) years and has worked in multiple capacities within the Regulatory Affairs space as a project and program manager, client-vendor relationship, and account manager, and an authorized US-FDA liaison. Prior to joining Freyr, Hiteshri worked with a medical device consulting company, where she actively contributed to expanding the company’s client portfolio. Hiteshri’s experience also involves scientific research in the biochemistry and molecular biology space, and she was a core team member of a cancer stem cell marker expression project that was awarded an NIH grant. She is currently managing global Regulatory registrations of a biotechnology company’s COVID-19 vaccine at Freyr.
In this webinar, our Malaysian Regulatory experts - Zulkhurnain Utar and Hiteshri Choksi will elaborate on:
- Overview of the Malaysian Medicine Market
- Act & Regulations
- Product Categories and its Regulatory Pathways
- Regulatory Challenges in the Malaysian Medicinal Market
- Success Story
- Freyr’s Solutions & Services for MPR
Given the keynotes and with due respect to your busy schedule, we really look forward to seeing you in the webinar. Register now! Stay informed. Stay compliant.