AGAH Annual Meeting 2018

(25) 26 to 27 April 2018, Munich

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.

Conference Title

Target organs in early medicines development – predictability and prevention of adverse reactions

Venue

Munich, Kardinal-Wendel-Haus

Date

Wednesday, 25th April 2018 (Pre-Workshop & General Assembly)
Thursday, 26th April 2018
Friday, 27th April 2018

Fees

Workshop “Pharmacovigilance in early phase drug development –
basic terms and key conceptsBasic principles of immunology” 25 April 2018
Member*170 EUR
Non-Member200 EUR
AGAH Annual Meeting 2018 „Target organs in early medicines developm ent -
predicta bility and prevention of adverse reactions“, 26-27 April 2018 (early bird until January 31, 2018)
early birdregular
Member* 320 EUR370 EUR
Non-Member400 EUR470 EUR
Junior Scientists (under age 30)170 EUR270 EUR
Day Ticket270 EUR
Conference-Networking-Dinner 60 EUR
*of the AGAH, AHPPI, BAPU, Club Phase I, EUFEMED

Language

Englisch

Program committee

K. Breithaupt-Grögler, C. Coch, F. Donath, K. Erb-Zohar, C. Hinze, M. Iovino, J. Rengelshausen, B. Schug, G. Wensing

Pre-Workshop: Wednesday, 25th April 2018

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

13:00 – 13:45

Assessment / compilation of safety data – key concepts (AE, SAE, SUSAR, ADR, SADR, expected/listed, side effect, dechallenge, rechallenge, placebo, nocebo)

(AE, SAE, SUSAR, ADR, SADR, expected/listed, side effect, dechallenge, rechallenge, placebo, nocebo)

A. Blank, Heidelberg (Germany)

13:45 – 14:30

Identification of important risks – Key documents on safety information
(Good pharmacovigilance practice, risk management plan, investigators’ brochure, company core data sheet / SmPC, development safety update report (DSUR), periodic safety update report (PSUR)

M. Weber, Schwalbach (Germany)

14:30 – 14:45Break
14:45 – 15:15

Useful tools for the evaluation of adverse events (CTC-AE, designated AEs, EMA list of important medical events)
(CTC-AE, designated AEs, EMA list of important medical events)

K. Erb-Zohar, Hanau (Germany)

15:15 – 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 – 16:30Break

Stop dose escalation or continue dosing? – Case study developed 
in break-out groups
K. Erb-Zohar, Hanau (Germany)
17:45 – 18:00Wrap up and end of meeting
18:15Get together
19:00 AGAH General Assembly

Day 1: Thursday, 26th April 2018

08:45

Welcome and Introduction
Barbara 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. Böttcher, Wuppertal (Germany); J. Rengelshausen, Aachen (Germany)

09:45 – 10:15

Relevant new renal function biomarkers?
P. Murray, Dublin (Ireland)

10:15 – 10:45Renal function in early phase trials
M. Böttcher, Wuppertal (Germany)
10:45 – 11:15

Break

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

11:15 – 11:45

Safety assessment of hepatic findings in non-clinical studies
S. Plassmann, München (Germany)

11:45 – 12:15Findings 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)

13:00 – 14:00 Break

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

14:00 – 14:30Preclinical Screening for CNS effects of potential drug substances
M. Traebert, Basel (Switzerland)
14:30 – 15:00Physico-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)

15:45 – 16:15 Break

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

16:15 – 16:45

Influence of contractility of cardiomyocytes – pathophysiology of cardiac muscle toxicity
U. Ravens, Dresden (Germany)

16:45 – 17:15QTc 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)

19:30Conference Networking-Dinner 

Day 2: Friday, 27th April 2018

Session 5: Local tolerance in drugs intended for alternate routes of administration
Chairs: E. Röhrdanz, 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 – 10:30Guideline on non-clinical local tolerance testing of medicinal products: regulatory perspectives
E. Röhrdanz, Bonn (Germany)
10:30 – 10:45Room for discussion
10:45 – 11:15Break

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 – 12:45

tba
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12:30 – 13:00 Open forum discussion
13:00Concluding remarks
Georg Wensing, Wuppertal (Germany)
13:15Farewell lunch

Contact and further information

Association for Applied Human Pharmacology (AGAH) e.V.
office: Goernestraße 30
20249 Hamburg

phone: +49 170 7844438
e-Mail: info ( a t ) agah.eu
Web: www.agah.eu

Registration

CSi Hamburg GmbH
Conferences | Symposia | Incentives
PCO Professional Conference Organizer
Goernestraße 30
20249 Hamburg
Germany

phone: +49 40 30770300
fax: +49 40 30770301
e-Mail: agah-veranstaltungen ( a t ) csihamburg.de

Online Registration

www.csioffice.de/agah2018