Fortbildung bei der DGRA e.V.


Advanced Therapy Medicinal Product Development and Regenerative Medicine

25. - 26. November 2008 in Langen


Dienstag, 25. November 2008 | 12.00 Uhr bis 19.00 Uhr
Mittwoch, 26. November 2008 | 09.00 Uhr bis 14.40 Uhr Termin in den eigenen Kalender übertragen


Paul-Ehrlich-Straße 51-59, 63225 Langen
Tel.: 06103 77 0

  • Programmvorschau Änderungen vorbehalten

    Programm am 25. November 2008

    12.00 Welcome
      K. Cichutek, Vice-President, PEI
    12.10 Advanced therapy medicinal products (ATMP) legislation, regulation, certification
      M. Terberger – tbc
    12.40 Session 1: Legislation, incentives and advice
      Chair: C. Schröder (PEI)
    12.45 Implementation of advanced therapy regulations at EMEA
      P. Celis
    13.10 Implementation of ATMP legislation in national law
      A. Dwenger
    13.35 Micro, small and medium-sized enterprises (SME)
      M. Carr
    14.00 Coffee Break
    15.00 Session 2: Regulatory requirements for marketing authorization, dossier requirements
      Chair: U. Granzer (Granzer Consulting), J. Scherer (PEI)
    15.05 Requirements Annex I as amended (2003/63/EC) – requirements for MAA
      M. Terberger – tbc
    15.30 Risk management plan and pharmacovigilance
      B. Keller-Stanislawski
    15.55 Enviromental Risk Assessment
      Chr. Buchholz
    16.20 Coffee Break
    17.00 Session 3: Impact on stakeholders (with panel discussion)
      Chair: W. Schwerdtfeger (German Federal Ministry of Health), K. Cichutek (PEI)
    17.05 Advanced Therapies Medicinal Products from the Governmental Point of View
      S. Brandt
    17.20 Comments of industry regarding the regulatory requirements
      H. Joseph
    17.35 Position of industry under the special consideration of SMEs
      B. Sickmüller
    17.50 Reimbursement
      P. T. Sawicki
    18.05 Panel Discussion
    19.00 Reception
    20.00 Dinner

    Programm am 26. November 2008

    9.00 Challenges with advanced therapies
      C. Schneider
    9.30 Session 4: Quality aspects of ATMPs
      Chair: G. Dallmann (NDA), R. Seitz (PEI)
    9.35 Quality requirements for cell-based medicinal products
      P. Salmikangas
    9.55 Quality requirements for gene therapy products
      S. Schüle
    10.20 International harmonisation for gene therapy medicinal products
      S. Longhurst
    10.45 Microbial safety
      T. Montag-Lessing
    11.10 Virus safety of advanced therapy medicinal products
      J. Blümel
    11.35 Break
    12.35 Session 5: (Non)-Clinical aspects of ATMPs
      Chair: A. Hilger (PEI), M. Schüssler-Lenz, (PEI)
      Non-clinical models for cell-based medicinal products
      E. Flory
    13.00 Clinical requirements for tissue engineered products. Challenges and possible solutions
      R. Mačiulaitis
    13.25 Design of pivotal clinical trials for gene therapy medicinal products
      G. Narayanan
    13.50 Clinical follow-up and traceability
      B. Klug
    14.15 Comments of industry regarding requirements for (non)-clinical trials under special
      consideration of ATMPs already legally on the market
    A. Emmendörfer
    14:40 Closing remarks
      K. Cichutek

  • Kostenbeitrag und Stornierungen

    Fees (Conference and Dinner):

    For DGRA members: € 250,-

    For non-members: € 350,-

    Es gelten die allgemeinen Veranstaltungshinweise / AGB's.

  • Anreise und Unterkunft

    A limited number of rooms are available for participants at special rates in the hotels listed below. Bookings under the special condition are requested until 25 October 2008.

    When making reservations please refer to this event.

    ACHAT Hotel
    Robert-Bosch-Str. 58
    D- 63225 Langen (Germany)

    Phone: + 49 (0) 6103 / 7560
    Fax: + 49 (0) 6103 / 756999

    Hotel Steigenberger MAXX Langen
    SRS Worldhotels
    Robert-Bosch-Str. 26
    D-63225 Langen (Germany)

    Phone: + 49 (0) 6103 / 9720
    Fax: + 49 (0) 6103 / 972555