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