November 06, 2018 - November 06, 2018
Date: 6 November 2018
Duration: 1 Day
Location: Amsterdam Area, The Netherlands
Language: Presentations will be in English
Cost: Regular € 875.-
Early Bird € 800.- (until 1 October 2018)
The new EU-MDR brings about many changes, including many definitions, reclassifications, new conformity assessment routes, new notified body designations and more. Stricter requirements on safety of ingredients, on clinical evidence and on consistency in regulatory compliance. Much more detailing in the essential principles, and above all: no grandfathering.
The training will discuss the options available for the transition from MDD to MDR, it will highlight timelines, resources, Notified Body approach, and the top 10 changes for technical documentation. This training focusses on practical guidance to implement the gaps assessments needed for dossiers, QMS and perhaps specific for clinical. It will provide details on product portfolio review, and on determining the impact of the regulation. High-level project planning will be included. The day will be filled with discussions and case studies.
- Highlights of transition from MDD to MDR
- Strategic options in the transition phase
- How to do a gap assessment of your technical documentation, use of templates and checklists
- How to do a gap assessment of your QMS, use of templates, checklists and management summaries.
- How to do a gap assessment of clinical evaluation, use of templates and checklists.
- Portfolio review
- Impact assessment
- High-level implementation planning
- Case studies
- Questions & Answers
- Evaluation of the Course and Closing
- Learn to perform various gap assessments at the start of MDR project
- Learn to reflect on the portfolio
- Learn to structure implementation project
- Understand how to build and use assessment lists, tools, and templates
Who should attend
RA manager, RA director, QA manager, QA director, Clinical Director, Marketing Manager, Sales Manager, international registration department