European Regulatory Affairs
Training Overview
Improve Your Ability to:
- Enter European markets expeditiously by surpassing drug registration hurdles
- Navigate European drug approval processed smoothly and efficiently to avoid costly delays
- Adhere to EU legistlation governing drug products (directives, regulations and guidelines) and ensure compliance with EMEA regulatory requirements
- Determine when and how to use the Centralized, Mutual Recognition and Decentralized procedures to help submit successfully in the EU
- Conduct clinical trials in accordance with the clinical trial directive requirements to help protect patient safety and ensure a successful launch of your clinical site in the EU
- Interact more effectively with the EMEA to help optimize time to market
- Identify criteria for orphan drug and other unique types of applications to effectively prepare for every product type
- Determine the effects of the additional of 10+ member states and be prepared for the regulatory repercussions of EU enlargement
PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-04-092-L04, Initial release: 04/2004.
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.