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. Taking the appropriate steps and implementing them into your development process may begin earlier than you expect and is essential.
Join this exclusive webinar where we define the process and discuss key milestones, potential gaps, and opportunities for a successful MAA. We will provide expert tips and identify the most important aspects you need to build a successful MAA strategy. You will learn how to ensure compliance, avoid late surprises, and maximise the value of your program at all phases of development.
Learning Objectives:
- 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 focused scientific advice, 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
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 Member 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.
Senior Director Global Regulatory Affairs
CATO SMS
Dr. van Hoorn has 25 years’ experience in the life science sector, of which 15 years in Regulatory Affairs. Having seen all aspects of drug development from early stage until late stage, including market access and life cycle management from Regulatory Affairs and overalls point overview. He has experience with HA interactions, such as pre-IND, IMPD, type B and C meetings, Scientific advice, Orphan Drug Designation (and oral hearings), break through designation, Prime, pre-submission meetings etc. He has been involved in authoring of M1-M5 and leading MAA, NDA, and BLA’s for biotech and pharma products. Dr. van Hoorn is a strong strategist, operational excellence, clear communicator, and has passion for his client and the patients/subjects.
Vice President Regulatory Affairs
CATO SMS
Dr. Hileman 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.