Introductory Course in Early Medicines Development – Part I

17.02.2015 – 19.02.2015 in Frankfurt am Main

Introduction and Learning Outcomes

This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts several days 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

Day 1: Tuesday, 17 February 2015

08:45 – 09:15

Introduction of faculty and participants

Wolfgang Timmer, Kerstin Breithaupt

09:15 – 09:30

Overview on Part I training course

Wolfgang Timmer, Kerstin Breithaupt
09:30 – 10:30

Overview on the process of clinical drug development (nonclinical studies, evaluation of toxicity, pharmacokinetics, pharmacodynamics, first-in-man, Phase 0, Phases I to III, exploratory vs. confirmatory trials, Phase IV, non-interventional studies / post-marketing surveillance, epidemiological studies)

Kerstin Breithaupt

10:30 – 11:00 Break
11:00 – 12:00 Design elements of human pharmacology trials (populations, number of patients in Phase I, randomisation procedures, controlled, placebo, staggered timing, cross-over, parallel-group, single-blind, double-blind, dose-escalation, single dose, multiple dose, etc.)
Wolfgang Timmer
12:00 – 12:45

Regulatory and ethical aspects of trial conduct I (risk-benefit evaluation, Declaration of Helsinki, EU-Directives, ICH-Guidelines)

Kerstin Breithaupt
12:45 – 13:45 Break
13:45 – 14:45

Regulatory and ethical aspects of trial conduct II (trial authorisation: ethics committee favourable opinion and competent authority approval, submission and marketing authorisation)

Kerstin Breithaupt
14:45 – 15:30

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

Kerstin Breithaupt

15:30 – 16:00 Break
16:00 – 18:00

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 [proof of concept], children, elderly, gender, ethnicities, cultural differences)

Katharina Erb-Zohar, Jörg Täubel

Day 2: Wednesday, 18 February 2015

08:45 – 10:15

Most common clinical pharmacology trials: FIM, safety, exploratory PK and PD, PoC trials, drug-drug-interaction, drug-food interaction, bioavailability, bioequivalence, QTc trial, adaptive designs, basic concepts of clinical development planning 

Wolfgang Timmer 

10:15 – 10:45

Conduct of clinical trials – site selection

Katharina Erb-Zohar

10:45 – 11:15 Break
11:15 – 11:45

Conduct of clinical trials – practical aspects of Phase I studies

Katharina Erb-Zohar

11:45 – 12:30

Subject informed consent: How to inform healthy subjects or patients about an early phase clinical trial? 

Kerstin Breithaupt

12:30 – 13:30 Break
13:30 – 15:00

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) 

Georg Wensing

15:00 – 15:30


15:30 – 17:00

Trial medication (drug substance / product, route of administration, formulations / drug-food interaction, specific aspects of preparation / administration / storage in Phase I, drug accountability, test / reference therapy, blinding, double-dummy, challenging substances, labelling, stabilisation, IMPD information, Non-IMPD medication, code breaking envelopes / emergency unblinding, release process according to ANNEX 13)

Barbara Schug

17:00 – 18:00

Questions and answers

Kerstin Breithaupt, Barbara Schug, Georg Wensing, Wolfgang Timmer

19:30 Dinner Meeting

Day 3: Thursday, 19 February 2015

08:30 –

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

Andreas Kovar

09:45 –
10:00 –

Pharmacokinetics II: pharmacogenetics / polymorphisms, pharmacometrics, PK/PD relationship

Andreas Kovar

11:15 –

Conduct of clinical trials – monitoring

Christian Hinze

12:15 –
12:30 –

Test on Part I contents of Human Pharmacology Training;

participation in test is mandatory to receive the certificate of attendance!

Kerstin Breithaupt, Christian Hinze

13:15 –

Feed back Part I

Kerstin Breithaupt, Christian Hinze

13:45 –
Farewell Lunch and end of Part I

Attendance Fees

1.100 €
1.450 €
Members of the AGAH, BAPU, Club Phase I, AHPPI, DGPharMed, DGKliPha
1900 €

2500 €

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


Registration | Workshop Office:

CSi Hamburg GmbH
Jungfrauenthal 22
D-20149 Hamburg
Phone: +49 40 307720 97
Telefax: +49 40 846097 60
E-Mail: agah-veranstaltungen ( a t )


Hotel und Tagungszentrum am Dominikanerkloster
Dominikanergasse 5
60311 Frankfurt am Main


May we please ask you to use the registration form.