This training course focuses on ICH international standards related to pharmacovigilance (ICH E2 series). It covers both pre- and post-authorisation pharmacovigilance standards and practical implementation of the ICH guidelines in the international environment. The course includes case studies and examples of challenges and practical solutions. The course is prepared and taught by experienced pharmacovigilance experts. Participants will gain solid knowledge and a clear understanding of international approaches to drug safety pharmacovigilance, as well as the best practices for successful local and global regulatory applications.
The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom has accredited this training course with 12 CPD credits.
The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 12 credits.
What You Will Learn
- ICH E2A Pre-marketing safety
- ICH E2D Definitions and standards for expedited reporting (post–approval)
- ICH E2B (both pre-and post-authorisation) Data elements for electronic submission
- ICH E2F Development Safety Update Report
- ICH E2C(R2) Periodic Benefit Risk Evaluation Report (PBRER) Guideline
- ICH E2E Pharmacovigilance planning
Who Should Attend
Professionals with background in the following areas:
- Clinical Research
- Clinical Safety/Pharmacovigilance
- Information Technology/Document Management
- Public Policy/Law/Compliance
- Regulatory Affairs
- Research & Development
- Risk Management
At the conclusion of this course, participants should be able to:
- Understand the international history, the principles and regulatory framework for pre- and post- approval clinical safety/pharmacovigilance
- Recognise the need for international safety surveillance and understand the regulatory requirements
- Understand the basic definitions of terms, scope of work, and purpose of pharmacovigilance used in day-to-day work
- Demonstrate an awareness of risk management and optimal risk minimisation methods
If you register for both The 10th Middle East Regulatory Conference (MERC) 2013 and The ICH Endorsed Pharmacovigilance Training Course, you will receive 50% off the ICH Endorsed Pharmacovigilance Training Course fee - this offer is only available by emailing firstname.lastname@example.org.
Hotel & Travel
The DIA has blocked a limited number of rooms at the following hotel:
Barr Al Jissah Hotel
P.O. Box 644
Sultanate of Oman
Tel.: 00968 2477 6666
Fax: 00968 2477 6677
at the rate of:
OMR 70.00 Al Bandar Deluxe Room single occupancy and OMR 80.00 double occupancy inclusive of breakfast buffet, exclusive of service charge and taxes of 17%.
To make your reservation, please use this booking form
Important: The room rate is available until 21 August 2013 or until the group block is sold-out, whichever comes first.
Cancellation: No show charges to apply without a notification from the hotel. Bookings cancelled after 22 July 2013 will be charged 100% cancellation fee.