Fortbildung bei der DGRA e.V.

The Program on May 7, 2015

9.30 am	Opening of the Annual Congress and introduction to sessions
	Dr. Ulrich Granzer
9.45 am	I. Clinical Trial Regulation - accompanying national rules
	Min Rat Dr. Lars-Christoph Nickel, BMG
	II. Clincial Trial Regulation – challenges for National Competent Authorities a) Perspective of PEI
	Dr. Hartmut Krafft, PEI
11.00 am	Coffee break
	II. b) Perspective of BfArM
	PD Dr. Thomas Sudhop, BfArM
11.30 am	III. Clincial Trial Regulation - a) Perspective of the Pharmaceutical Industry
	Prof. Dr. Barbara Sickmüller, DGRA
	b) Perspective of the CROs
	Dr. Dagmar Chase, BVMA Chair
12.15 pm	Panel Diskussion
12.45 pm	Lunch break
2.15 pm	IV. EU-Portal for CTAs and EUDRA CT Database Update
	Dr. Dagmar Dörmann; BMG
3.00 pm	V. EMA Transparency policy §42b
	Freedom of information act Legal assessment Clinical trials data
	Prof. Burkhard Sträter; Kanzlei Sträter Rechtsanwälte
3.30 pm	Panel Discussion with all Speakers
3.45 pm	Coffee break
4.15 pm	DGRA Members’ Meeting
	(ends at around 6.00 pm)
7.00 pm	Pre-dinner Speech
	Reception and buffet

 

The Program on May 8, 2015

9.30 am	“Walter-Cyran-Medaille” award
10.00 am	VI. Pharmacovigilance Referral
	Dr. June Munro Raine, MHRA, PRAC Chair EMA
11.00 am	Coffee break
11.30 am	VII. National Pharmacovigilance Update
	Educational material DHPC Anwendungsbeobachtungen Impact of selected new EU-Guidance documents
	Dr. Norbert Paeschke, Head of Pharmacovigilance BfArM
12.15 pm	VIII. Experiences with a referral procedure Art 31 on an OTC-product: A company perspective
	What was the trigger? Thoughts around a Response-Strategy Special challenges for an OTC-product Response and List of outstanding issues Oral explanation meeting Lessons learned
	Dr. Petra Kammann, Boehringer Ingelheim Pharma GmbH & Co KG
1.00 pm	Panel Discussion with all speakers
1.15 pm	Lunch / Snack

For DGRA members: € 460,-
For non-members: € 590,-

Student price: Students of DRA course (MDRA XVI) and delegates of bodies (Behörden) who are members of the DGRA: € 260,-

Sie möchten Mitglied in der DGRA e.V. werden?

Informationen zur Mitgliedschaft

Cancellation terms

Up to two weeks before the first day of the conference (23-April-2014): € 50;
up to one week before the first day of the conference (30-April-2014): 50% of fee;
late cancellations: full conference fee if a substitute participant (DGRA member) cannot be put forward.

In the event of cancellation by the organizer, any fees already paid will be fully reimbursed.

With the cooperation of DGRA e.V. and the Deutsche Bahn you travel relaxed and comfortably to your DGRA education and training events in 2015. The price for your ticket for a return trip to Bonn is 99 € (2nd class) and 159 € (1st class). Detailed information and booking options for this offer can be found here.

Für die Teilnehmer stehen in den u.g. Hotels begrenzte Zimmerkontingente zu Sonderkonditionen zur Verfügung.
Nehmen Sie die Reservierung bitte unter Hinweis auf die DGRA und diese Veranstaltung vor.

Galerie Design Hotel Bonn
Telefon: +49 (0) 228 1848-0
Fax: +49 (0) 228 1848-1825

Ameron Hotel Königshof
Tel.: + 49 (0) 228-26010
Fax: + 49 (0) 228-2601-529

Villa Godesberg
Tel.: + 49 (0) 228-830060
Fax: + 49 (0) 228-8300690

Hilton Hotel Bonn
Tel.: + 49 (0) 228-72690
Fax: + 49 (0) 228-7269-700

Günnewig Hotel Residence
Tel.: 0228-2697-0
Fax: 0228-2697-777

Kameha Grand Bonn
Tel: +49 (228) 43 34 50 00
Fax: +49 (228) 43 34 50 05

Weitere Hotelzimmer in der Bonner Innenstadt können Sie auch hier buchen.

Walter-Cyran-Medaille

Presentations on May 07, 2015

I. Die Verordnung (EU) 536/2014 und die nationale Umsetzung
Min Rat Dr. Lars-Christoph Nickel, Federal Ministry of Health (BMG), Bonn

II.a) The Clinical Trial Regulation: Challenges for National Competent Authorities - Perspective of the Paul-Ehrlich Institut
Dr. Hartmut Krafft, Paul-Ehrlich Institute (PEI), Langen

II.b) Clinical Trial Regulation: Challenges for National Competent Authorities - Perspective of BfArM
PD Dr. Thomas Sudhop, Federal Institute for Drugs and Medical Devices (BfArM), Bonn

III.a) Clinical Trial Regulation – Perspective of the Pharmaceutical Industry
Prof. Dr. Barbara Sickmüller, DGRA e.V., Bonn

III.b) Clinical Trials Regulation (EU) No 536/2014 - Perspective of the CROs
Dr. Dagmar Chase, BVMA e.V. - Federal Association of Contract Research Organisations, Munich

IV. European Legislation: The "New" Regulation on Clinical Trials on Medicinal Products for Human Use - EU Portal and Database
Dr. Dagmar Dörmann, Federal Ministry of Health (BMG), Bonn

V. EMA - Transparency Policy
Prof. Burkhard Sträter, Kanzlei Sträter Rechtsanwälte, Bonn 

Presentations on May 08, 2015

VI. Pharmacovigilance Referral
Dr. June Munro Raine, Medicines and Healthcare Products Regulatory Agency (MHRA), PRAC Chair EMA, London

VII. Pharmacovigilance Update - national
Dr. Norbert Paeschke, Federal Institute for Drugs and Medical Devices (BfArM), Bonn

VIII. Experiences with a referral procedure Art 31 on an OTC-product: A company perspective
Dr. Petra Kammann, Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim