Headshot

Noraisyah Mohd Sani

Senior Principal Assistant Director National Pharmaceutical Regulatory Agency

Noraisyah Mohd Sani, Ph.D., completed her doctoral studies in Pharmaceutical Policy and Practice at the Universiti Malaya, Malaysia. Prior to this, she received her Master’s degree in Pharmaceutical Analysis from the Universiti Kebangsaan Malaysia, following her undergraduate studies in Pharmacy at the Universiti Sains Malaysia in 2001.

Since 2002, Noraisyah has served as a pharmacist at the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health, Malaysia. Throughout her tenure, she has held various positions and undertaken diverse responsibilities within the NPRA, including leadership roles such as head of the pharmacovigilance section and head of the biologics section. Her regulatory expertise encompasses the evaluation of medicinal products for marketing approval and the oversight of post-marketing activities.

Actively engaged in both international and local regulatory dialogues, Noraisyah has contributed significantly to discussions on regulatory matters. She also played a pivotal role in developing NPRA guidelines for the Facilitated Registration Pathway, utilising a reliance approach.

Currently, Noraisyah’s focus lies on enhancing efficiency without compromising the quality, safety, and efficacy of medicinal products. She remains committed to staying updated on the latest developments and advancements in regulatory science.

See Noraisyah Mohd Sani at this event

  • Day 2 Wednesday 4 December

Reliance case studies and lessons learned

07:30 - 09:00 CET / 17:30 - 19:00 AEDT