Approval of your Marketing Authorisation Application (MAA) is the final hurdle to pharmaceutical product launch in Europe. Adequate and timely navigation of this roadmap is essential to achieve a successful review by the EMA. Navigation of the drug development pathways towards MAA approval starts much earlier than you may know till date and is essential in order to reach your goal. You need to begin strategizing, planning, and preparing early enough in the drug development process not to lose valuable time to market.
A panel of CATO SMS’ regulatory experts will take you through the process and discuss the key milestones, potential gaps to consider, and opportunities for drug development in Europe. They will provide expert tips and point out the most important aspects you need to be aware of in order to build a successful MAA strategy for your product.
We will examine the regulatory process, starting from CMC, Non-Clinical and Clinical and up to the final stage of understanding the reimbursement systems and policies and demonstrate it with various case studies. You will learn how to ensure not only compliance but discover effective ways to avoid late surprises and maximize the value of your development program at all phases of development. Opportunities for accelerated assessment as well as specifics of orphan drug designation and paediatric development will also be discussed and exemplified throughout the webinar.
Webinar Key Points Will Include:
- Identification and creation of targeted strategic opportunities for your European MAA
- Avoidance of early gaps, late critical path issues, and pre-submission validation issues
- Preparation for pre-submission meetings, and understanding the right timing to ask key specific questions
- Reimbursement policies in Europe and their implications
- Utilising the synergies and understanding the differences between filing requirements and pathways in Europe versus the US
- Opportunities for accelerated assessment, specifics of orphan drug designation, and paediatric development
Diana Radovan, Ph.D., ELS
Associate Director Regulatory Affairs CATO SMS
Dr. Radovan has 10 years’ professional experience in regulatory strategy, consulting, and writing, with a clinical focus. In her current position as Associate Director Regulatory Affairs at CATO SMS, she is responsible for advising clients on global regulatory and clinical development strategies, developing the business in the EU, and defining EU-specific processes. Prior to this role, Dr. Radovan served as a regulatory consultant and medical writer in different pharma and consulting companies, namely Biopharma Excellence, Trilogy, Sandoz/Novartis, and Boehringer Ingelheim. She is experienced with global submissions and a broad range of documents and regulatory requirements. Dr. Radovan serves on the EMWA PV SIG Committee and is an EMWA Workshop Leader on advanced professional techniques related to the efficient development of fit-for-purpose regulatory documents. She is also an experienced workshop leader on fundamentals of clinical development and biostatistics, as well as on effective data presentation strategies. She holds a PhD degree in Biophysical Chemistry from IMPRS-CMB Dortmund/TU Dortmund, an ELS degree from BELS, and certificates in medical writing from EMWA.
Gregory A. Hileman, Ph.D.
Vice President Regulatory Affairs CATO SMS
Dr. Hileman has more than 35 years’ research and industrial experience, including 25 years in strategic regulatory affairs. He has led drug development meetings with most FDA divisions and contributed to submission of multiple fast track designation requests, breakthrough therapy designation requests, FDA meeting packages, INDs, NDAs, and BLAs. Dr. Hileman currently leads CATO SMS’s regulatory strategy group and serves as primary FDA contact for multiple sponsors. Dr. Hileman has clinical and product development experience in neurology, psychiatry, oncology, gastroenterology, cardiology, and women’s health.