EU Marketing Authorisation (MRP+DCP+CMD/h) Challenges for Generics in the New European Environment   
Dr. T. Faust

European Legislation 
- Changes in the Pharmacovigilance   system in the Review 2005
Dr. Axel Thiele

EU & USA Paediatric Legislations And The Integration Of Paediatric Drug Development Into The General Drug Development Process   -
Klaus Rose, Head Pediatrics, Medical Science, Roche PharmaceuticalsDisclaimer

Ten years EU regulatory frame for  changing the classification of the medicines (OTC-Switch). Analysis and Member State examples.
Assoc. Prof. Guenka Petrova, Assoc. Prof. Ilko Getov, Faculty of Pharmacy, Medical University-Sofia

Regulation on medicinal products  for paediatric use 
Burkhard Sträter

Assessment of Bioequivalence Studies from regulatory perspective
Ivanka Atanasova, MD, PhD, Associate Professor, Bulgarain Drug Agency

Experience of the Paul Ehrlich Institute (PEI) with the approval of clinical trial applications after almost 3 years of the new German Drug Law  
Hartmut Krafft, PhD Head, Clinical Trials Unit Paul-Ehrlich Institute, Langen, Germany

Challenges for the implementation of the Pharmaceutical review 2005/06 in Bulgaria – an industry perspective
Andrey Mladenov, MD, MBA - Director medical and regulatory affairs SOPHARMA PHARMACEUTICALS

The New Paediatric Regulation - Establishment and Role of the Paediatric Committee (PDCO)
Daniel Brasseur - Chair of the PEG at the EMEA

Clinical Trials  
Directive for Clinical Trials. The EU Clinical Trials Directive – legal background.     
Birka Lehmann