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Applying Continuity to Your Submission Process: From Regulatory Strategy and Statistical Methodology to Market Access
About the Webinar
In this webinar, Luca Pani, MD, Vice President for Regulatory Strategy and Market Access Innovation of WCG VeraSci, and Janet Wittes, PhD, President Emerita and Founder of WCG Statistics Collaborative, will discuss how to apply continuity to your regulatory submission process.
Dr. Luca Pani and Janet Wittes, PhD, will address essential topics and questions, such as:
- Challenges and opportunities for emerging biopharma companies in the current landscape of the regulatory submission process today, and how these differ for mid-to-large pharma
- How critical outside statistical, scientific, and medical expertise is in preparing to face the market as an emerging biopharma company
- How to ensure your data support the efficacy and safety profile of your drug, especially in the study of rare and orphan diseases
- Recommendations for emerging biopharma companies who are preparing for the global development and submission readiness for CNS diseases as well as other conditions
Meet the Speakers
- Luca Pani, MD, Vice President for Regulatory Strategy and Market Access Innovation of WCG VeraSci. Dr. Pani is former Director General of the Italian Medicines Agency (AIFA), CHMP and SAWP Member of the European Medicine Agency (EMA) and a globally recognized expert in psychiatry, pharmacology, regulatory science, and market access negotiation model contracts. During his tenure as Director General of AIFA, he pioneered several new approaches to drug approval, pricing, and reimbursement strategies by using advanced informatics to follow and certify real-world data. As a European regulator, Dr. Pani has been a leading figure for approval and scientific advice for CNS products and served as Chair of both the European Union Board Telematics Committee and of the European Risk Management Strategy Facilitation Group.
- Janet Wittes, PhD, President Emerita and Founder of WCG Statistics Collaborative. Dr. Wittes is a member of many advisory committees, including a number of Data Monitoring Committees (DMCs) for randomized clinical trials sponsored by industry or government. She is a former member of the Food and Drug Administration (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (2014–2018) and a current member of the Circulatory System Devices Panel. She has held leadership positions in may large randomized trials in a number of therapeutic areas and has been actively involved in drug for orphan diseases. Her publications include many contributions to statistical methods for clinical trials.
- Melissa Bomben, MS, Senior Vice President, Clinical Solutions, WCG