EU Regulatory Network - Challenges and Opportunities for Croatia

• Date:
  Fredag, 14 november 2008, Hele dagen
• Placering:
  European Medicines Agency, Amsterdam, the Netherlands

This conference, organised for the 5th anniversary of the Croatian Agency for Medicinal Products and Medical Devices (ALMP), was of great importance to Croatia's application for EU membership. It targeted scientific audiences and included specific activities with a view to informing the full cross-section of stakeholders in Croatia.

Documents

EU Regulatory Network - Challenges and Opportunities for Croatia - Announcement

Agenda - EU Regulatory Network - Challenges and Opportunities for Croatia

Successful Rijeka conference strengthens EU-Croatian cooperation on medicines regulation

Reference Number: EMEA/605819/2008

EU Regulatory Network - List of Participants

Welcome speech - Sylvie Benefice, EMEA

Reference Number: EMEA/589654/2008

Welcome speech - Sinisa Tomic, ALMP, Croatia

Reference Number: EMEA/662143/2008

Initiative of the EU Commission: Follow up to the Public consultation on the future of the pharmaceutical sector - Martin Terberger

WHO - Pharmaceutical Policies - Milan Smid

European Directorate for the Quality of Medicines & HealthCare: Structure, Aims and Role in Providing Safety and Quality of Medicines in Europe - Susanne Keitel

EMEA/CHMP-Think Tank Group on Innovation, Research and Drug Development - Xavier Luria

The post-accession experience - Rodica Badescu

How can non-conributing agencies be encouraged to participate - Kristin Raudsepp

Transatlantic simplification of administrative procedures - Arielle North

Priorities of the Regulatory Authorities - Aginus A.W. Kalis

Development of an efficient regulatory system in Europe - Point of view of the NCA - Jean Marimbert

Advances in Croatia's rapproachment to the EU - Sinisa Tomic

The role of the PDCO - Gà©rard Pons

Implementation of Advanced therapies - Anthony Humphreys

Revised Guidelines on Bioequivalence - Monica Edholm

Overview of Review Process Interactions - Anthony Humphreys

Impact on new variation system on NCAs - Susanne Winterscheid

E-Submission: From 2005 to 2008, A great step forward - Andrà© Lhoir

Session Report: Pharmacovigilance

Reference Number: EMEA/640479/2008

European Commission's proposal for Pharmacovigilence - Martin Terberger

EudraVigilance to support EU Pharmacovigilance Activities - Thomas Goedecke

Risk Management Plans - Stella Blackburn

GCP Inspection - Gabrielle Schwarz

Fighting the Parmaceutical Crime and Counterfeit Medicines - Roy Vancauwenberghe

Overview of GMP Inspections conducted by Irish Medicines Board - Lorraine Nolan

Pharmacovigilance Inspections - Johanna Piper

Closing speech - Sylvie Benefice, EMA

Reference Number: EMEA/616285/2008