AGAH-Workshop “Introductory Course in Exploratory Medicines Development – Part I”

30.11.2016 – 2.12.2016 in Oberursel

Introduction and Learning Outcomes

This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of 3 days each provide a concise overview on Human Pharmacology / Translational Medicine spanning from non-clinical pharmacology and toxicology over first-in-man studies to proof-of-concept clinical trials.

Learning Outcomes

On successful completion of Part 1, students should be able to demonstrate an understanding / knowledge of the following:  

  • principal steps in drug development – from compound selection to marketing application and beyond
  • pertinent issues involved in the undertaking of early clinical research
  • specific aspects of how to set-up and conduct early phase clinical trials
  • regulation of medicines in Europe
  • development and review of compound-specific information to ensure adherence to scientific, medical, ethical, and legal provisions
  • integration of pertinent available scientific information into an IB and a clinical trial protocol
  • principles of trial design, protocol submission and clinical conduct
  • selection of appropriate trial population
  • most common early phase clinical trials and their specific requirements
  • assessment and evaluation of safety data from clinical trials
  • relevance of formulation properties and in vitro characteristics of the trial medication for design and planning of an early phase clinical trial
  • basics of pharmacokinetics
  • defining pharmacokinetic (PK) endpoints for early phase clinical trials
  • method validation according to good clinical (GCP) and good laboratory (GLP) practise
  • practical aspects of bioequivalence trials

Day 1: Wednesday, 30 November 2016

09:00 – 09:30

Introduction of faculty and participants  

09:30 - 10:30

Overview on the drug development process: Nonclinical studies, evaluation of toxicity, pharmacokinetics, pharmacodynamics, First-in-human, Phases I to III, exploratory vs. confirmatory trials, submission and marketing authorisation; Phase IV, non-interventional studies / post-marketing surveillance, epidemiological studies; go/no-go decision making, definition of proof-of-mechanism (PoM), proof-of-concept (PoC)
Prof. Dr. G, Wensing

10:30 – 10:45


10:45 – 12:15 Design elements of human pharmacology trials: Number of subjects in Phase I, randomisation procedures, controlled / uncontrolled, placebo / active control, staggered timing, cross-over / parallel-group, single-blind / double-blind,  single dose / multiple dose, dose-escalation, umbrella protocols, adaptive elements, microdosing studies
Dr. W. Timmer
12:15 – 13:00

Regulatory and ethical aspects of trial conduct I: risk-benefit evaluation, Declaration of Helsinki, EU-Directive and Regulation, ICH-Guidelines
Dr. K. Breithaupt-Grögler

13:00 – 14:00 Break
14:00 – 14:45

Regulatory and ethical aspects of trial conduct II: Trial authorisation: ethics committee favourable opinion and competent authority approval, submission and marketing authorisation
Dr. K. Breithaupt-Grögler

14:45 – 15:00 Break
15:00 – 17:00

Most common early phase clinical trials: FIH, safety, exploratory PK and PD, PoC trials, drug-drug-interaction, drug-food interaction, bioavailability, bioequivalence, QTc trials

Dr. W. Timmer

17:00 – 17:15 Break
17:15 – 18:00

Trial protocol and investigator's brochure: How to integrate information from scientific literature, nonclinical / clinical information and other sources; primary and secondary objectives vs. endpoints, differences between IB and IMPD

Dr. K. Breithaupt-Grögler

Day 2: Thursday, 01 December 2016

08:45 - 10:15

Selection of trial population and definition of inclusion / exclusion criteria in early drug development: Healthy subjects (special emphasis on „when is a subject healthy“?), symptomatic subjects, patients in early phase, children, elderly, gender, ethnicities, cultural differences
Dr. K. Erb-Zohar

10:15 – 10:45

Conduct of clinical trials: Site selection
Dr. K. Erb-Zohar

10:45 – 11:15 Break
11:15 – 11:45

Conduct of clinical trials: Practical aspects in planning of early phase trials
Dr. S. Baumann

11:45 – 12:30

Conduct of clinical trials: Subject / patient informed consent in early phase clinical trials 
Dr. K. Breithaupt-Grögler

12:30 – 13:30 Break
13:30 – 14:45

Conduct of clinical trials: Safety parameters and stopping criteria (AE, SAE, ADR, SUSAR), relationship to trial medication, severity of AE, liver / renal toxicity, general tolerability, local tolerance, monitoring of vital signs
Dr. A. Blank

14:45 – 15:30 Conduct of clinical trials: Monitoring
C. Hinze
15:30 – 15:45


15:45 – 16:15 Conduct of clinical trials: Independent data monitoring committee
Dr. K. Erb-Zohar
16:15 – 17:45

Trial medication: drug substance / product, labelling, stability, drug accountability, code breaking envelopes / emergency unblinding, specific aspects of preparation / administration / storage in Phase I, route of administration, formulations, fasted or fed conditions, blinding, double-dummy, test / reference therapy, challenging substances, IMPD information, non-IMPD medication, release process according to ANNEX 1

Dr. B. Schug

Day 3: Friday, 02 December 2016

08:45 – 10:45

Pharmacokinetics I: ADME, drug-drug interaction, drug-food interaction, bioequivalence / bioavailability, steady state, accumulation factors
Dr. A. Kovar

10:45 – 11:00 Break
11:00 – 13:00

Pharmacokinetics II: pharmacogenetics / polymorphisms, pharmacometrics, PK/PD relationship
Dr. A. Kovar

13:00 – 13:45


13:45 – 14:45

GCP / GLP – focus on method validation: Bioanalytics, sample collection, sample preparation, quality assurance procedures
Dr. B. Schug
14:45 – 15:00


15:00 – 16:00

Bioequivalence trials: Design development and realization – practical examples, specific aspects besides the classical standard design

Dr. B. Schug

16:00 – 16:45 

Mandatory Test on Part I
50% of questions must be correctly answered to pass test and receive a certificate)

16:45 – 17:00 Feed back & End of Part I

Attendance Fees

1.100 €
1.450 €
Members of the AGAH, BAPU, Club Phase I, AHPPI, DGPharMed, DGKliPha
1.900 €

2.500 €

Part I plus II  
for Members of the AGAH, BAPU, Club Phase I, AHPPI, DGPharMed, DGKliPha

Part I plus II for Non-Members

Special fees for students are available on request

This course will be accredited by the Landesärztekammer, participants will be awarded ”Fortbildungspunkte”.
More information will be given in due time


SocraTec R&D GmbH
Im Setzling 35
61440 Oberursel

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 )

This workshop is supported by PreClinical Safety (PCS) Consultants Ltd.


CSi Hamburg GmbH
Conferences | Symposia | Incentives
Goernestraße 30
20249 Hamburg

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

May we please ask you to use the registration form.