Are You Reg. Ready? Getting Your Medical Affairs Team Primed to Manage New Regulatory Requirements
There’s been plenty of discussion on the submission scope of current EU MDR and pending EU IVDR regulatory requirements for medical device manufactures. But what of organizational change management readiness? How should a medical device organization’s different business functions collaborate and align their people, processes, and knowledge to meet these regulatory requirements effectively and efficiently?
This webinar provides you with a behind the scenes look at how one company is managing change within their organization. Dr. Imelda Omana-Zapata, BD Senior Manager Clinical Projects, provides an overview of how she is planning and coordinating change within her organization to meet upcoming EU IVDR regulatory requirements. Also joining Imelda is Laurie Mitchell, Founder and President of Criterion Edge, a medical device regulatory writing service provider, who discusses the critical technology and expertise required to meet more rigorous scientific validated submissions to notify bodies.
Listening to this webinar, you will learn:
- Key steps involved in helping medical affairs transition to a more rigorous regulatory environments.
- How to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
- Critical systematic literature review technology and experience required to ensure CER and PER submissions are audit-ready and compliant.