Name: 27th AGAH Annual Meeting 2018
Start: 2018-04-25T00:00:00+02:00
End: 2018-04-27T23:59:59+02:00
Location: Annual Meeting 2018

25. April 2018 - 27. April 2018
Annual Meeting 2018, München

We are most happy to invite you to the AGAH Annual Meeting in April 2018 in Munich.

The conference will focus on how to predict as well as on how to prevent adverse drug reactions in early phase drug development. The major target organ systems will be addressed: liver, kidney, CNS, cardiac function. Further sessions will be dedicated to local tolerance and immunotoxicity.

We will look into how animal models and in vitro data may help to estimate risk regarding human administration. How can kidney and liver function best be monitored in the settings of early phase trials? What do we need to know to assess potential CNS adverse drug reactions early on? What are the pathophysiological mechanisms leading to potential cardiac toxicity? What are the guidelines on non-clinical local tolerance testing? How to monitor immunotoxicity in novel immunological therapies? There will be ample opportunity to discuss these and additional questions with expert speakers, regulators and ethic committees members as well as colleagues from pharmaceutical industry, CRO and academia.

The meeting starts with a one-day pre-conference workshop about basic terms and key concepts of pharmacovigilance with a strong focus on early phase drug development. This workshop offers an excellent preparation for the annual meeting for those who are not yet experts in the field.

Fees

Workshop “Pharmacovigilance in early phase drug development – basic terms and key concepts
Basic principles of immunology” 25 April 2018

Member*	170 EUR
Non-Member	200 EUR

AGAH Annual Meeting 2018 „Target organs in early medicines development - predictability and prevention of adverse reactions“, 26-27 April 2018 (early bird until 31 January, 2018 extended: 07 February 2018)

	early bird	regular
Member*	320 EUR	370 EUR
Non-Member	400 EUR	470 EUR
Junior Scientists (under age 30)	170 EUR	270 EUR
Day Ticket		270 EUR
Conference-Networking-Dinner		60 EUR

*of the AGAH, AHPPI, BAPU, Club Phase I, EUFEMED

Pre-Workshop: Wednesday, 25th April 2018

Pharmacovigilance in early phase drug development – basic terms and key concepts
Chairs: K. Breithaupt-Groegler, Frankfurt (Germany); K. Erb-Zohar, Hanau (Germany)

13:00 – 13:45

Identification, assessment, and communication of adverse events in (early phase) clinical trials
A. Blank, Heidelberg (Germany)

13:45 – 14:30

Identification of risks – Key documents on safety information
(Investigator’s brochure, company core data sheet, company core safety information, summary of product characteristics, risk management plan, development safety update report, periodic safety update report/ periodic risk-benefit evaluation report)

M. Weber, Ingelheim am Rhein (Germany)

14:30 – 14:45 Break

14:45 – 15:05

Useful tools for the evaluation of adverse events (CTCAE, designated medical events, EMA List of important medical events)

K. Erb-Zohar, Hanau (Germany)

15:05 – 15:45

Management of safety signals in early phase drug development

U. Vogel, Ingelheim (Germany)

15:45 – 16:15

»Safety Review Committee« in early phase trials

J. Graff, Frankfurt (Germany)

16:15 – 16:30 Break

Stop dose escalation or continue dosing? – Case study developed in break-out groups

K. Erb-Zohar, Hanau (Germany)

17:45 – 18:00 Wrap up and end of meeting

18:15 Get together

19:00 AGAH General Assembly

Day 1: Thursday, 26th April 2018

08:45

Welcome and Introduction
B. Schug, Oberursel (Germany)

09:00

Hypersensitivity reactions and adverse drug reactions
Sir Munir Pirmohamed, Liverpool (United Kingdom)

Session 1: Drug-induced renal function impairment
Chairs: M. Boettcher, Wuppertal (Germany); J. Rengelshausen, Aachen (Germany)

09:45 – 10:15

Relevant new renal function biomarkers?

P. Murray, Dublin (Ireland)

10:15 – 10:45

Renal function in early phase trials

M. Boettcher, Wuppertal (Germany)

10:45 – 11:15 Break

Session 2: Drug-induced liver injury
Chairs: S. Plassmann, Munich (Germany); G. Wensing, Wuppertal (Germany)

11:15 – 11:45

Safety assessment of hepatic findings in non-clinical studies

S. Plassmann, Munich (Germany)

11:45 – 12:15

Findings on hepatic function parameters in early phase trials with healthy subjects

D. Jung, Wuppertal (Germany)

12:15 – 12:45

Clinical interpretation of hepatic safety biomarkers

M. Merz, Zurich (Switzerland)

12:45 – 13:00 Discussion

15:45 – 16:15 Break

Session 3: Drug-induced CNS adverse reactions
Chairs: F. Donath, Erfurt (Germany); J. Stingl, Bonn (Germany)

14:00 – 14:30

Preclinical Screening for CNS effects of potential drug substances

M. Traebert, Basel (Switzerland)

14:30 – 15:00

Physico-chemical drug properties and human CNS system characteristics: determinants of CNS pharmacokinetics at different locations in human brain

E. de Lange, Leiden (The Netherlands)

15:00 – 15:30

Prediction and detection of off-target drug effects on mental health: from neuronal cell models to neuroimaging

J. Stingl, Bonn (Germany)

15:30-15:45 Discussion

15:45 – 16:15 Break

Session 4: Drug-induced adverse reactions on the cardiac system
Chairs: M. Iovino, Biberach; J. Taubel, London

16:15 – 16:45

Influence of contractility of cardiomyocytes – pathophysiology of cardiac muscle toxicity

U. Ravens, Freiburg i. Breisgau (Germany)

16:45 – 17:15

QTc assessment strategies in early phase development

B. Darpo, Stockholm (Sweden)

17:15 – 17:45

Waivers on TQT trials – a critical appraisal

Expert panel discussion with S. Baumann, Berlin (Germany); N. Beetz, Biberach (Germany); B. Darpo, Stockholm (Sweden); D. Kubitza, Wuppertal (Germany); J. Taubel, London (United Kingdom)

19:30 Conference Networking-Dinner

Day 2: Friday, 27th April 2018

Session 5: Local tolerance in drugs intended for alternate routes of administration
Chairs: E. Roehrdanz, Bonn (Germany); B. Schug, Oberursel (Germany)

09:00 – 09:30

Non-animal research models: imitation of three-dimensional cavities for risk assessment in respiratory tract

S. Constant, Geneva (Switzerland)

09:30 – 10:00

Risk assessment for dermal application: how to estimate skin irritation and sensitisation from animal and in-vitro data

D. Basketter, Sharnbrook (United Kingdom)

10:00 – 10:30

Guideline on non-clinical local tolerance testing of medicinal products: regulatory perspectives

E. Roehrdanz, Bonn (Germany)

10:30 – 10:45 Discussion

10:45 – 11:15 Break

Session 6: Immunotoxicity
Chairs: C. Coch, Bonn (Germany); J. Descotes, Lyon (France)

11:15 – 11:45

Immunological safety issues in early clinical trials: a translational approach

J. Descotes, Lyon (France)

11:45 – 12:15

Challenges and approaches for predicting immunogenicity

P. Mayer, Bonn (Germany)

12:15 – 12:55

Safety and immunogenecity for Gene Therapy Medicinal Products and Therapeutic Vaccines

M. Goldammer; N. Kirsch-Stefan, Langen (Germany)

12:55 – 13:10 Discussion

13:10

Concluding remarks

G. Wensing, Wuppertal (Germany)

13:20

Farewell lunch

subject to modifications, status February 2018

Speaker / Chairs

Basketter Daniel, Dr.
DABMEB Consultancy Ltd · Sharnbrook/United Kingdom
Baumann Sybille, Dr.
CRS Clinical Research Services Berlin GmbH · Berlin/Germany
Beetz Nadine, Dr.
Boehringer Ingelheim International GmbH · Biberach/Germany
Blank Antje, Dr.
Heidelberg University Hospital · Heidelberg/Germany
Boettcher Michael
Bayer Pharma AG · Wuppertal/Germany
Breithaupt-Groegler Kerstin, Dr.
-kbr- clinical pharmacology services Frankfurt/M./Germany
Coch Christoph, Dr.
University Hospital Bonn · Bonn/Germany
Constant Samuel
Geneva/Switzerland
Darpo Borje, Prof.
iCardiac Technologies · Lidingo/Sweden
de Lange Elisabeth, Dr. E.C.M.
Leiden University · Leiden/The Netherlands
Descotes Jacques, Prof.
Claude Bernard University · Lyon/France
Donath Frank, Dr.
SocraTec R&D GmbH · Erfurt/Germany
Erb-Zohar Katharina, Dr.
clinphase · Hanau/Germany
Goldammer, Mark
Paul-Ehrlich-Institut · Langen/Germany
Graff Jochen, Dr.
Frauenhofer IME · Frankfurt /Germany
Iovino Mario, Dr.
Boehringer Ingelheim International GmbH · Biberach/Germany
Jung David, Dr.
Bayer Pharma AG · Leverkusen/Germany
Kubitza Dagmar, Dr.
Bayer AG · Wuppertal/Germany
Kirsch-Stefan, Nadine
Paul-Ehrlich-Institut · Langen/Germany
Mayer Peter, PD Dr.
Bundesinstitut für Arzneimittel und Medizinprodukte Bonn/Germany
Merz Michael, Dr.
UniversityHospital Zurich · Zurich/Switzerland
Murray Patrick, Prof.
University College Dublin · Dublin/Ireland
Sir Munir Pirmohamed, Prof. Dr.
University of Liverpool · Liverpool/United Kingdom
Plassmann Stephanie, Dr.
PreClinical Safety (PCS) Consultants Ltd. · Munich/Germany
Ravens Ursula, Prof. Dr.
University Heart Center Freiburg Freiburg im Breisgau/Germany
Rengelshausen Jens, Dr.
Grünenthal GmbH · Aachen/Germany
Roehrdanz Elke, Dr.
Bundesinstitut für Arzneimittel und Medizinprodukte Bonn/Germany
Schug Barbara, Dr.
SocraTec R&D GmbH · Oberursel/Germany
Stingl Julia, Prof. Dr.
Bundesinstitut für Arzneimittel und Medizinprodukte Bonn/Germany
Taubel Jorg, Dr.
Richmond Pharmacology Ltd. · London/United Kingdom
Traebert Martin, Dr.
Novartis Pharma AG · Basel /Schweiz
Vogel Ulrich, Dr.
Boehringer Ingelheim International GmbH Ingelheim am Rhein/Germany
Weber Maria, Dr.
Boehringer Ingelheim International GmbH · Ingelheim am Rhein/Germany
Wensing Georg, Prof. Dr.
Bayer Pharma AG · Wuppertal/Germany