Quality Digest

This webinar will discuss in brief all the new EU clinical directives, its Impact and how companies can effectively align their processes to effectively implement the requirements of the regulations.

Areas Covered in the seminar:

* EU Agency Regulatory Structure
* Registration Options
* Company Strategy- Linking Clinical Trials & Marketing Authorization Applications
* Balancing Strategy and Long Term Regulatory Cost & Maintenance
* Product Registration Options - National Procedure, Traditional Mutual Recognition & Decentralized Procedures, Centralized Procedures (EMEA)
* Abridged Applications ( Similar Products and Devices, Request for Extensions)
* Maintaining Your licenses- Variations
o New Variation Rules and Classifications Across the EU and When They’ll be in Force
o What Does This Mean for Your Regulatory Team
o Labeling and Packaging Leaflet Requirements ( Mutual Recognition Procedure, Centralized Procedure )
* Common Steps of the Licensing Review Procedures
o Validating the Submission
o How Can I Check Where My Application Stands
o Favorable Standing Committee Opinion
o Non-favorable Opinion
* Review of Regulatory Authorities
o International, Regional, and Local laws applicable for each European Union Nation
* Member State Analysis of Applicable Regulations at all levels with Practical Examples of How the Regulations are Applied
o National Legislation Tied to Directives
o Objectives of the Rules Governing Medicinal Procedures
o Regulatory Framework
o New Products, Requirements, & Procedures
* Political Implications of the Regulations / Directives
o Compare/Contrast EMA and the FDA procedures
* How and When to Influence the Regulatory Processn
o Effective Monitoring Activity
o Association vs.. Individual Company Involvement & Intervention
o The Regulatory Negotiation Process
o Effective Approaches
o The Do’s and Don’ts of Regulatory Involvement

More Info

Please contact Customer Care to avail 15% Christmas Offer on Regular Pricing (650-620-3937)