Beatriz joined the NDA Advisory Board in 2013. She is an expert in non-clinical safety strategies for chemical, biological & advanced therapies. Her strategic & scientific expertise is essential for the successful development of new medicinal products, emerging technologies and the regulatory expectations set by the Agencies.
Key Areas Of Expertise
- Extensive expertise in the inner workings of the EU regulatory systems
- Regulatory strategies for biological products and emerging technologies
- Pre-clinical drug development plans, scientific strategy, and design
- Including non-clinical pharmacology, pharmacokinetics, and toxicology for new medicinal products
- Biopharmaceuticals including gene and cellular therapies
- Mechanistic safety
- Professor of Pharmacology, Pharmacotoxicology and Regulatory Science at the Lisbon University, Faculty of PharmacyProfessional presentation skills and extensive teaching experience
Before Joining The NDA Advisory Board
Beatriz was an expert in non-clinical and regulatory science at the Portuguese agency, Infarmed and the EMA. She was a member of the Committee of Human Medicines (CHMP), Committee of Advanced Therapies (CAT) and Scientific Advice Working Party (SAWP). She was also the Chair of the Safety Working Party (SWP) and involved in ICH discussions on several non-clinical guidelines on behalf of the European Commission.
Beatriz holds a PharmD and PhD in Pharmacology, she is the Head of the Department of Pharmacological Sciences and has acted as Chair of the Scientific Committee of the Innovative Medicines Initiative (IMI) between 2014 and 2018.
Professor Beatriz Silva Lima