Fortbildung bei der DGRA e.V.

	The Program on May 8, 2014
9.30 am	Opening of the Annual Congress and introduction to sessions, Dr. Ulrich Granzer
9.45 am	I. Joint Scientific Advice (JSA) - BfArM G-BA
	Endpoints, Biomakers, Surrogat Endpoints, Comparative Therapy Procedures of BfArM - Routine or Exception? Prof. Dr. Karl Broich, Vice President BfArM
	II. JSA in Germany with BfArM/PEI and G-BA
	Joined Scientific Advice by G-BA with BfArM and PEI Right Time in Product Development Level of Commitment of the Early Benefit Assessment Participipation of the G-BA in Scientific Advice Pilots at European Level Thomas Müller, head of department “Medicinal products” Federal Joint Committee G-BA
11.00 am	Coffee break
11.30 am	III. National Review from the perspective of the pharmaceutical industry
	Experiences with early G-BA advice and involvement of BfArM/PEI Procedure of National Scientific Advice with G-BA Dr. Anja Langeneckert, Head of Regulatory Affairs, Roche Pharma
	IV. Parallel Scientific Advice by EMA with MAHs and HTAs
	EMA procedures - Experiences and Outlook Participation of HTA Bodies Assessment of HTA aspects in EPAR Dr. Tomas Salmonson, CHMP Chair EMA
12.15 pm	Panel Diskussion
12.45 pm	Lunch break
14.15 pm	V. European Review from the perspective of the pharmaceutical industry
	Experiences with EMA/HTA Bodies and EUnet/HTA What are the industrial expectations? What is realistic? What is desirable? Britta Paschen, Vice President Health Services Research, Merck KG aA
14.45 pm	Panel Discussion with all speakers
15.00 pm	“Walter-Cyran-Medaille” award
15.30 pm	Coffee break
16.00 pm	DGRA Members’ Meeting (ends at around 6.00 pm)
19.00 pm	Pre-dinner Speech Reception and buffet
	The Program on May 09, 2014
9.30 am	“DGRA-Förderpreis“ award
10.00 am	VI. Pharmacovigilance Update Europe EU Risk Management Plan (RMP)/Risk Minimisation Measures PASS (Post Authorisation Safety Studies) Medication Errors / Off Lable Use Paediatric Pharmacovigilance Dr. Dirk Mentzer, PEI, PDCO Chair
11.00 am	Coffee break
11.30 am	VII. National Pharmacovigilance Update
	Adverse Drug Reactions (ADRs) reporting (nue EMA Business rules in accordance with E2B (R3)) PSURs, PSUR repository Implementation of PRAC Decisions during the signal procedure AWB: Announcement and database News in the Development of MedDRA: Results of Blue Ribbon Panel of MSSO Dr. Norbert Paeschke, Head of Pharmacovigilance BfArM
12.15 pm	VIII. Review from the perspective of the pharmaceutical industry Dr. Ulrich Granzer, Munich
13.00 pm	Panel Discussion with all speakers
13.15 pm	Lunch / Snack

 

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

Student price: Students of DRA course (MDRA XI) 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 (24-April-2014): € 50;
up to one week before the first day of the conference (01-May-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 2014. 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.

 

A limited number of rooms are available for participants at special rates in the hotels listed
below. When making reservations please refer to this event.


Hotel (Günnewig) Bristol
Prinz-Albert-Strasse 2
D-53113 Bonn
Tel.: +49(0)228 / 26 98-0
Fax: +49(0)228 / 26 98-2 22


Sternhotel
Markt 8
D-53111 Bonn
Tel.: +49(0)228 / 72 67-0
Fax: +49(0)228 / 72 67-125


Hotel (Günnewig) Residence
Kaiserplatz 11
D-53113 Bonn
Tel: +49(0)228 / 26 97-0
Fax: +49(0)228 / 26 97-777


Hotel Hilton
Berliner Freiheit 2
53111 Bonn
Tel: +49(0)228 / 72 69-0
Fax: +49(0)228 / 72 69-700


Hotel Maritim
Godesberger Allee
53175 Bonn
Tel.: +49(0)228 / 81 08-0
Fax: +49(0)228 / 81 08-811


Villa Godesberg
Mirbachstrasse 2a
53173 Bonn - Bad Godesberg
Tel.: 0228 / 83 00 6-0
Fax: 0228 / 83 00 6-90

Walter-Cyran-Medaille

Presentations on May 08, 2014

Joint Scientific Advice - Interaction of BfArM and G-BA
Prof. Dr. Karl Broich, Federal Institute for Drugs and Medical Devices (BfArM), Bonn

JSA in Germany with BfArM/PEI and G-BA
Thomas Müller, Federal Joint Committee (G-BA), Berlin

Experiences with early G-BA advice and involvement of BfArM/PEI
Dr. Anja Langeneckert, Roche Pharma AG, Grenzach

Parallel Scientific Advice By EMA with MAHs & HTAs
Tomas Salmonson, European Medicine Agency (EMA), London

European Review from the Perspective of the Pharmaceutical Industry
Britta Paschen, Merck KGaA, Darmstadt

Presentations on May 09, 2014

"DGRA-Förderpreis" award
Project-, Drug-, and Business Development in a Biotech SME
Dr. Christian Hanke

Pharmacovigilance Update Europe
Dr. Dirk Mentzer, Paul-Ehrlich-Institut (PEI), Langen

National Pharmacovigilance update
Dr. Norbert Paeschke, Federal Institute for Drugs and Medical Devices (BfArM), Bonn

PRAC Experience
Dr. Ulrich Granzer, Granzer Consulting, München