Janet has been with NDA since 2001 and has extensive experience of non-clinical development throughout the product lifecycle. She specialises in authoring/reviewing non-clinical documentation to meet expectations of regulatory agencies.
Key Areas Of Expertise
- Extensive experience of nonclinical development throughout the product lifecycle
- Nonclinical and regulatory advice at all levels of product development, from early development through MAA/NDA/BLA to post-approval
- Preparation and compilation of nonclinical documentation for MAA/NDA/BLA, including preparation of Nonclinical Overview (Module 2.4), Nonclinical Summaries (Module 2.6) and nonclinical sections of Risk Management Plan
- Strategic input and preparation of responses to agency non-clinical questions
- Preparation and review of a variety of nonclinical documentation during product development (IB, IMPD, IND, CTA, Scientific Advice, Briefing Documents, PIP, ATC applications)
- Preparation of nonclinical gap analysis for products prior to or post MAA submission
- Experience in the preparation of Phase I environmental risk assessments
Janet completed a post-doctoral fellowship in toxicology followed by positions in regulatory affairs at TIL Occam, Medeva Pharma and Celltech.
Janet has a BSc (Hons) Biological Sciences, MSc Toxicology, MSc Pharmaceutical Sciences, and a PhD in Toxicology.
Dr Janet Makowska