Roadmap to Marketing Authorization in Europe: Taking all the right turns
Approval of your Marketing Authorization 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 maximize the value of your program at all phases of development.
Webinar 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
- Utilizing 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
Speakers:
Diana Radovan, Ph.D, Associate Director Regulatory Affairs, CATO SMS
Gregory A. Hileman, Ph.D, Vice President Regulatory Affairs, CATO SMS
