Jahr 2004

DGRA-Jahreskongress

16. - 17. Juni 2004 in Bonn

Moderation

Prof. Burkhard Sträter

Termine

Mittwoch, 16. Juni 2004 | 10.00 Uhr bis 19.00 Uhr
Donnerstag, 17. Juni 2004 | 09.00 Uhr bis 14.00 Uhr Termin in den eigenen Kalender übertragen

Veranstaltungsort

Wasserwerk Bonn
Hermann-Ehlers-Straße Eingang V, 53113 Bonn
Tel.: +49 (0)228 / 92 67 - 0
Routenplaner

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Programm | DOC, 82 KB

Programmvorschau Änderungen vorbehalten

	Programm am 21. Juni 2004

10.00	Welcome address by Professor K.-W. Glombitza - President of the DGRA
	A. Implementation of the review 2004 in the enlarged European Union Regulatory Challenges from EU-Commission view point Dr. Birka Lehmann, EU Commission, Pharmaceutical Unit, Brussels

11.15	Coffee Break

11.45	B. The networking medicines agencies in Europe
	Dr. Jytte Lyngvig, Lægemiddelstyrelsen, Kopenhagen EMEA Management Board, Vice-chairman

13.00	Lunch Break

14.30	C. Innovations in the decentralized procedure and in mutual recognition
	Dr. P. Bachmann, BfArM, Bonn
	D. Regulatory strategies in the new European system Dr. Ulrich Granzer, Granzer Regulatory Consulting & Services, München

15.45	Coffee Break

16.15	E. Analysis of safety data for gene therapy clinical studies
	PD Dr. Steven Hirschfeld, FDA, Rockville
	F. Regulatory aspects of gene transfer medicinal products Dr. Ch. Buchholz, PEI, Langen
	G. FDA – EMEA Interaction ImplicationsRepercussions for the pharmaceutical industry Dr. Isabelle Stöckert, BayerHealthcare AG, Wuppertal (Ends at around 18.00)

19.00	Evening program at Hotel Königshof, Bonn
	Award of the Walter Cyran Medal 2004 Eulogy: Professor H. G. Schweim Award of the certificates to the Master of Drug Regulatory Affairs (M.D.R.A.) by Professor K.-W. Glombitza, Bonn University Followed by reception with buffet at Hotel Königshof (open-ended)


	Programm am 17. Juni 2004

9.00	Opening by the moderator B. Sträter (Attorney-at-Law)
	H. Clinical Trials Directive (2001/20/EC) – implementation in the member states

	1. Introduction to the topic Prof. Dr. Barbara Sickmüller, BPI, Member of EFPIA STR- Policy Committee
	2a. Status of the procedure from the point of view of the member states Dr. Brian Davis, Medicines and Healthcare, Products Regulatory Authority (MHRA), London Dr. Kerstin Westermark, Läkemedelsverket, Uppsala

10.30	Coffee Break

11.00	2b. Status of the procedure from the point of view of the member states
	Prof. Dr. János Borvendég, National Institute of Pharmacy, Budapest Dr. Hartmut Krafft, PEI, Germany MinRat. PD Dr. Walter Schwerdtfeger, BMGS, Germany

	Panel discussion with the above speakers

13.00	End of annual conferenc

14.00	DGRA members’ meeting
	Moderator: Prof. Dr. H. G. Schweim

Kostenbeitrag und Stornierungen
For DGRA members: € 400,-
For nonmembers: € 550,-

For DRA students and institution representatives who are also DGRA members: € 200,-
- Up to two weeks before beginning of conference: € 50,-
- Up to one week before beginning of conference: 50% of fee
- Late cancellations: full conference fee if a substitute participant cannot be put forward
In the case of cancellation by the organizer, any fees already paid will be fully reimbursed.
Anreise und Unterkunft

Hotel (Günnewig) Bristol
Prinz-Albert-Strasse 2
53113 Bonn

Tel.: +49 (0) 228/26 98-0
Fax: +49 (0) 228/26 98-2 22

Hotel (Günnewig) Residence
Kaiserplatz 11
53113 Bonn

Tel.: +49 (0) 228/2697-0
Fax: +49 (0) 228/2697-777

Hotel Königshof
Adenauerallee 9
53111 Bonn

Tel.: +49 (0) 228/260 10
Fax: +49 (0) 228/260 15 29

Hotel Maritim
Godesberger Allee
53175 Bonn

Tel.: +49 (0) 228/81 08 845
Fax: +49 (0) 228/81 08 765

There are a limited number of rooms for participants at the aforementioned hotel.

Please mention this conference when making your reservation.
(The Hotel Königshof is situated about five minutes on foot from Hotel Bristol and Residence.)
Walter-Cyran-Medaille
Walter-Cyran-Medaille
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DGRA-Jahreskongress 2004
16. und 17. Juni 2004 in Bonn

Vorträge am 16. Juni 2004

Implementation of the review 2004 in the enlarged European Union
Dr. Birka Lehmann, EU Commission, Pharmaceutical Unit, Brussels

The Networking Medicines Agencies in Europe
Dr. Jytte Lyngvig, Lægemiddelstyrelsen, Kopenhagen, EMEA Management Board

Innovations in the Decentralized Procedure and Mutual Recognition
Dr. Susanne Keitel, BfArM, Bonn

Innovations in the Decentralised Procedure and in Mutual Recognition
Dr. Peter Bachmann, BfArM, Bonn

Regulatory Strategies in the New European System
Dr. Ulrich Granzer, Granzer Regulatory Consulting & Services, München

FDA CBER Gene Therapy Data Base: Preliminary Analysis of a Work in Progress
Dr. Steven Hirschfeld, FDA, Rockville, USA

Regulatory Aspects of Gene Transfer Medicinal Products
PD Dr. Christian J. Buchholz, Paul-Ehrlich-Institut (PEI), Langen

FDA - EMEA Interaction Implications for the Pharmaceutical Industry - Part 1
FDA - EMEA Interaction Implications for the Pharmaceutical Industry - Part 2
Dr. Isabelle Stöckert, Bayer HealthCare AG, Wuppertal

Vorträge am 17. Juni 2004

Clinical Trials Directive (2001/20/EC) Implementation in the EU - Member States
Prof. Dr. Barbara Sickmüller, Bundesverband der Pharmazeutischen Industrie (BPI), Berlin

Clinical Trials Directive (2001/20/EC) - Implementation in the UK
Dr. Brian Davis, MHRA, London

Implementing the Directive - from the Swedish Perspective
Dr. Kerstin Westermark, Läkemedelsverket, Uppsala

Impact of the Directive 2001/20/EC on the clinical trial regulation in Hungary
Prof. Dr. János Borvendég, National Institute of Pharmacy, Budapest

Clinical Trials Directive (2001/20/EC) Implementation in the member states
Hartmut Krafft, Paul-Ehrlich-Institut (PEI), Langen

Umsetzung der GCP-Richtlinie in Deutschland
Ministerialrat Priv.-Doz. Dr. Walter Schwerdtfeger, Bundesministerium für Gesundheit und Soziale Sicherung, Bonn

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