Академический Документы
Профессиональный Документы
Культура Документы
PROGRAMME
Objectives of the conference
2015 marked the 50th anniversary of the European
Union Pharmaceutical Legislation. Without any
doubt, this legislation has considerably improved
the safety, quality and efficacy of all kinds of medicines in the European Union and beyond. However, questions have been raised as to whether the
whole legislative and regulatory system for pharmaceuticals has not become too complex, hence
hindering access to important medicines - either
as a prescription or as a non-prescription medicine. More proportionality has therefore become
an important issue in the debate on the future
regulation of medicines. This concerns the marketing authorisation system in general including the
procedures for variations but in more specific
terms also the implications of the legislative provisions on pharmacovigilance and falsified medicines.
Immediate changes in the pharmaceutical legislation are unlikely to happen. The conference will
therefore focus on adjustements in the implementation of existing rules and consequently on improvements which can be made in a shorter time
frame. Specific attention will be paid to key issues
for the manufacturers of non-prescription medicines such as approval times, consistency in regulatory decisions, switching from prescription to
non-prescription status and umbrella branding.
The programme has been developed in close
cooperation with the Dutch Medicines Evaluation
Board, which will host the first meeting of the
Heads of EU Medicines Agencies during the Dutch
EU Presidency back to back to the conference.
Welcome coffee
09.00
Session 1
10.30
Break
PROGRAMME
11.00
Session 2
12.30
Lunch
13.30
Session 3
Committee (PRAC)
Peter Bachmann, Chair, Co-ordination group for
Mutual recognition and Decentralised procedureshuman (CMDh)
Paul Carter, Global Head Consumer Health Care,
Development, Medicine and Regulatory Affairs,
Boehringer Ingelheim
Elmar Kroth, Director, German Medicines
Manufacturers Association (BAH)
15.30
Break
16.00
Session 4
17.45
Conclusions
18.00