Fortbildung bei der DGRA e.V.

DGRA-Workshop

Workshop on drug policy, new pharmaceutical procedures in EC

18. - 19. April 2007 in Sofia

Moderation

Rechtsanwalt Prof. Burkhard Sträter
Prof. Burkhard Sträter

Termine

Mittwoch, 18. April 2007 | 08.45 Uhr bis 17.30 Uhr
Donnerstag, 19. April 2007 | 09.00 Uhr bis 15.00 Uhr Termin in den eigenen Kalender übertragen

Veranstaltungsort

Medical University Sofia, Bulgarien
Blvd Acad. Ivan Geshov 15, 1431 Sofia
Tel.: (02) 9531 174
Routenplaner

  • Programmvorschau Änderungen vorbehalten
     

    Programm am 18. April 2007

       
    8.45 Opening
       
    9.00 New European pharmaceutical Legislation in 2005
      General Principles - Major changes in the pharmaceutical legislation in 2005:
     
    • The New Decentralised Procedure – global marketing authorization
    • Introduction of the Europe an reference drug product
    • Implementation of the decree “Sunset”
    • Procedures for transparency
    Dr. S. Keitel, BfArM
       
    9.45 Experience in the implementation of the new European pharmaceutical legislation - 
      in data exclusivity and transparency rules
    B. Sträter, Attorney at Law
       
    10.15 Advantages and challenges in the pharmaceutical legislation 2005 for generics
      Dr. T. Benisheva, Faculty of Public Health
       
    10.45 Coffee Break
       
    11.15 EU Marketing Authorisation (MRP+DP+CMD/h/)
      Industry regulatory perspectives - Challenges for generics in the new European environment
    Dr. Th. Faust, Hexal AG
       
    12.00 Presentation and discussion of the Guideline “Potential risk to public health” 
      concerning medicines
    Dr. B. Lehmann, BfArM
       
      Discussion
       
    13.00 Lunch
       
    14.00 CMD(h) Procedures and challenges – one year experience
      Dr. P. Bachmann, BfArM
       
    14.45 An industry perspective/Challenges for the implementation of the pharmaceutical Review 
      2005 in Bulgaria
    Dr. A. Mladenov, Bulgarian pharmaceutical industry
       
    15.10 Ten years European regulatory frame for changing the classification of the medical product 
      (OTC-Switch) for human use (analysis and Member State examples)
    Dr. I. Getov, Dr. G. Petrova, Faculty of Pharmacy
       
    15.30 Coffee Break
       
    16.00 Pharmacovigilance
      European Legislation - Changes in the Pharmacovigilance system in the Review 2005
       
    17.30 New Pharmacovigilance obligations in the authorisation procedures:
     
    • The Pharmacovigilance System
    • The Risk Management System (ICH E2E)
    Dr. A. Thiele, BfArM; Dr. B. Borissov, Prescriptia Ltd
       
       
     

    Programm am 19. April 2007

    9.00 Clinical Trials
     

    Paediatric Medicines – the European regulatory framework, objective for the Regulation, Committee for clinical trials

    • The new Pediatric Regulation - Establishment and Role of the Pediatric Committee

    Dr. D. Brasseur, Belgium

       
    10.30 Coffee Break
       
    11.00 Paediatric Medicines – the European regulatory frame, objective for the Regulation
     
    • System of Incentives for paediatric research
    • Extension of Supplementary Protection Certificate, Data exclusivity for Paediatrics Marketing Authorization – PUMA
    RA. B. Sträter, Attorney at Law
     
    • Consequences for drug development
    Dr. K. Rose, Roche, Basel
       
    12.00 Lunch Breack
       
    13.00 Directive for clinical trials - The EU Clinical Trial Directive – legal background
      Dr. B. Lehmann, BfArM
       
    13.30 The authorization procedure for clinical trials – implementation in Germany
      Dr. H. Krafft, PEI
       
    14.30 Panel Discussion
     
    • Changes in the EU Pharmaceutical Legislation – chances and challenges for the Pharmaceutical Industry in Bulgaria
       
    15.00 Closing Remarks

  • Kostenbeitrag und Stornierungen

    Cost contribution: € 60,-

  • Anreise und Unterkunft

    Hotel Rila
    (Preis EZ: 50 - 60 E)

    Tel: +359/2/93 79 130
    Fax: +359/2/980 48 13

    e-mail: rila@mbox.contact.bg
    http://www.online.bg/rila/index-en.htm


    Hotel Central (4 Sterne)
    (Preis EZ : 70 - 90 €)
    Sofia 1000
    52 Hristo Botev

    Tel: +359/2/981 23 64
    Fax: +359/2/986 45 61
    e-mail cental@central-hotel.com
    www.central-hotel.com


    Central Hotel Forum (4 Sterne)
    (Preis EZ : 70 - 90 €)
    Sofia 1612
    41 Tzar Boris III Blvd

    Tel: +359/2/954 44 44
    Fax: +359/2/954 33 33
    e-mail cental@central-hotel.com
    www.central-hotel.com


    Hotel Anel (5 Sterne)
    (Preis EZ: 90 - 110 €)
    14 Todor Alexandrov Blvd.

    Tel: +359/2/911 99 00
    Fax: +359/2/911 97 61
    hotelanel@hotelanel.com
    www.hotelanel.com

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