CRED SMPC 2024

Speaker Biographies

Petrina Pearce Petrina Pearce is a Senior Manager Regulatory Affairs New Products at Advanz Pharma, where she assumes overall responsibility for the registration and successful delivery of new product pipeline products from product identification up to commercial launch. Petrina has over 30 years’ experience in the pharmaceutical industry, from analytical testing through to the licencing of Medicinal Products and Medical Devices. Prior to joining Advanz, Petrina was employed as Regulatory Affairs Manager at Diamond BioPharm where she predominantly provided support to clients for licensing and post licensing activities for National, MRP/DCP and Centralised Procedures. Prior to that, she worked in Regulatory Affairs for Forest Laboratories, where she gained broad experience in regulatory strategy, regulatory CMC and regulatory compliance and built a solid knowledge base of regulatory procedures and guidelines. Before moving into Regulatory Affairs, Petrina spent many years in Quality Assurance at GSK. During this time she was responsible for a variety of activities, such as the release of batches of active pharmaceutical ingredients, inspection readiness, GMP compliance and regulatory conformance, implementation/maintenance of the validation lifecycle for nominated processes and also the investigation of problems (including the implementation of corrective and preventative actions). Petrina possesses an honours degree in Chemistry and is a member of the Organisation for Professionals in Regulatory Affairs (TOPRA). Gabriela Fok Gabriela "Gaby" Fok (mTOPRA) has been in the pharma industry for over 10 years with global and local regulatory affairs experience in a broad range of countries and regions. Gabriela holds a BSc in Biochemistry and an MSc in Forensic Science. Since 2010, Gaby has been working in regulatory affairs, with a significant portion of her career dedicated to life-cycle management of Prescription Only Medicines (POM), Pharmacy Medicines (P), Over-the-Counter (OTC) products, and General Sales List (GSL) items, with a particular emphasis on safety and product labelling in medicinal products. Gaby has experience in consultancy as well, and in recent years, her focus has shifted towards new active substances. Since 2023, Gabriela has been recognised as a Chartered Scientist through TOPRA since December 2023. Gaby currently leads a team in Ipsen as a senior Regulatory Affairs Manager, providing life-cycle management as well as strategic regulatory input, for the UK and Ireland business, focusing on oncology and rare diseases. She is also an advocate for workplace well-being and is a trained first-aider for the office. Gaby has previously also implemented document management systems for regulatory affairs, and collaborated on process optimization projects, as well as interacting with several European health authorities. Gaby is fluent in English, Cantonese and Mandarin, currently learning Japanese and is currently completing her Chartered Scientist Application.