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ICH Endorsed Pharmacovigilance

Nov 28 2013 8:00AM - Nov 29 2013 3:45PM | HALMED (Agency for Medicinal Products and Medical Devices) Ulica Roberta Frangeša Mihanovica 9 (Sky Office) Zagreb, 100 00 Croatia (Hrvatska)

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This training course cannot be booked online. Please fill in the registration form or contact Vladimir Mitic at vladimir.mitic@croatiaairlines.hr

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.

Continuing Education

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

Learning Objectives 

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

Hotel & Travel 

A limited number of rooms has been blocked at the following hotel:
Hotel Antunovic
Zagrebacka Avenija 100 A
100 90 Zagreb

Tel.: +385 1 2041 121
Fax: +385 1 2041 762
Website: http://www.hotelantunovic.com/en/

at the rate of:
single room: EUR 95.00 per person per day incl. breakfast
double room: EUR 60.00 per person per day incl. breakfast
exclusive of city tax of EUR 1.00 per person per day

The hotel is situated approximately 15 min. walking distance from HALMED.

Important: The room rate is available until 30 October 2013 or until the group block is sold-out, whichever comes first.

Contact Information 

Teslina 5
100 00 Zagreb

Tel.: +385 1 6160 242
Fax: +385 1 6160 240
Email: vladimir.mitic@croatiaairlines.hr


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Registration Fees 

Other Fees

Government (Full Time)
Register Online
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