Scendea Presents: Key Regulatory Considerations for Biotech & Pharma Startups
Webinar Description: Join Scendea’s Regulatory experts for an insightful and in-depth webinar presentation covering the regulatory considerations for:
Non-clinical development guidelines in North American and European regions
Efficient and practical use of predicates towards preparing a robust regulatory pathway
Timelines for engagement; initial completion of the ideal therapeutic data package, impacts around pursuing a lead indication and opportunities for acceleration
Re-purposing drugs, obtaining “fast track” or other such designations
Planning a clinical trial program – leveraging academic resources and global geographies to cost effectively execute clinical studies in-line with regulatory jurisdictions (such as the US FDA & Health Canada)
About Scendea
Scendea is a leading product development and regulatory consulting group serving the pharmaceutical and biotechnology industry. Our international team offers strategic and operational support in the fields of quality/CMC, non-clinical/ toxicology, clinical/medical and regulatory, which guide products efficiently from early development to marketing approval. Scendea’s scientific excellence, industry experience, commercial awareness and a collaborative approach allow our expert team to solve complex issues associated with medicinal product development.
Meet the Speakers
Karen is a Principal Consultant at Scendea, responsible for providing nonclinical technical advice and product development strategies to our clients. Karen was formerly a Senior Nonclinical Assessor and Head of Nonclinical Assessment for Clinical Trials at the MHRA.
Karen has over 20 years’ experience in toxicology, having also previously worked for the NHS and Food Standards Agency. Karen holds a BSc (Hons) in Pharmacology and an MSc in Applied Toxicology.
Dr Caroline Keane is a Senior Consultant at Scendea with 20 years of experience working on both early and late-stage clinical programmes. Caroline has worked across a broad range of therapeutic areas including allergy and respiratory, Immunology, women’s health and oncology and haematology.
Caroline started her pharmaceutical career at Pfizer, working as a clinical development manager and was most recently a senior clinical scientist in oncology at Roche. Caroline holds a PhD in Immunology from University College Dublin.
