Introductory Course in Exploratory Medicines Development – Part I
AGAH Workshop, Oberursel
This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of 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.
This AGAH course meets the standards for high-quality postgraduate education and training in Medicines Development established by PharmaTrain and has been awarded a PharmaTrain Recognition. The course (Parts I plus II) was accredited 3 ECTS.
Introduction and Learning Outcomes
This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of 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
- method validation according to good clinical (GCP) and good laboratory (GLP) practise practical aspects of bioequivalence trials
This AGAH course meets the standards for high-quality postgraduate education and training in Medicines Development established by PharmaTrain and has been awarded a PharmaTrain Recognition. The course (in 2016/17) was accredited 3 ECTS (Parts I plus II).
Day 1: Wednesday, 13th February 2019
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)
Georg Wensing
10:30 – 10:45
Break
10:45 – 12:00
Design elements of human pharmacology trials: Controlled / uncontrolled, placebo / active control, cross-over / parallel-group, single-blind / double-blind, single dose / multiple dose, randomisation procedures, dose-escalation, staggered timing, combined protocols, adaptive elements, microdosing studies
Wolfgang Timmer
12:00 – 12:45
Regulatory and ethical aspects of trial conduct I: Risk-benefit evaluation, GCP, Declaration of Helsinki, EU-Directive and Regulation, ICH-Guidelines
Kerstin Breithaupt-Grögler
12:45 – 13:45
Break
13:45 – 14:30
Regulatory and ethical aspects of trial conduct II: Trial authorisation: ethics committee favourable opinion and competent authority approval
Kerstin Breithaupt-Grögler
14:45 – 15:00
Break
15:00 – 16:30
Most common early phase clinical trials: First-in-human, safety, exploratory PK and PD, drug-drug-interaction, drug-food interaction, bioavailability / bioequivalence, QTc trials, PoC trials
Wolfgang Timmer
16:30 – 17:00
First-in-human trials in patients: most common designs for dose escalation, relevant differences vs trials in healthy subjects
Antje Blank
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
Kerstin Breithaupt-Grögler
18:30 – 20:30
Get together: formation of break-out groups
Day 2: Thursday, 14th February 2019
08:45 – 10:30
Conduct of clinical trials (including case study): 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
Antje Blank
10:30 – 10:45
Break
10:45 – 12:00
Conduct of clinical trials (including case study): Practical aspects in planning of early phase trials
Sybille Baumann
12:00 – 13:00
Break
13:00 – 14:30
Selection of trial population and definition of inclusion / exclusion criteria in early drug development (including case study): Healthy subjects, symptomatic subjects, patients in early phase, children, elderly, gender, ethnicities, cultural differences
Katharina Erb-Zohar
14:30 – 15:00
Conduct of clinical trials: Site selection
Katharina Erb-Zohar
15:00 – 15:15
Break
15:15 – 15:45
Conduct of clinical trials: Independent data monitoring committee
Katharina Erb-Zohar
15:45 – 16:30
Conduct of clinical trials: Subject / patient informed consent in early phase clinical trials
Kerstin Breithaupt-Grögler
16:30 – 16:45
Break
16:45 – 18:15
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
André Warnke
Day 3: Friday, 15th February 2019
08:45 – 09:00
Discussion of homework: case studies: AE/SAE documentation, set-up of a FIH / a BE trial
Kerstin Breithaupt-Grögler
09:00 – 10:30
Pharmacokinetics I: ADME, drug-drug interaction, drug-food interaction, bioequivalence / bioavailability, steady state, accumulation factors
Andreas Kovar
10:30 – 10:45
Break
10:45 – 13:00
Pharmacokinetics II: pharmacogenetics / polymorphisms, pharmacometrics, PK/PD relationship
Andreas Kovar
13:00 – 13:45
Break
13:45 – 14:45
GCP / GLP – focus on method validation: Bioanalytics, sample collection, sample preparation, quality assurance procedures
André Warnke
14:00 – 14:15
Break
14:15 – 16:00
How to proceed from single ascending dose to multiple ascending dose? Assessment and evaluation of SAD safety and PK data, integrated protocols versus consecutive trials
Karin Göhler
14:45 – 15.00
Break
15:00 – 16:00
Bioequivalence trials: How to do it right – planning a successful BE trial
André Warnke
16:00 – 16.45
Mandatory Test on Part I (50% of questions must be correctly answered to pass test and receive a certificate)
Kerstin Breithaupt-Grögler
16:45 – 17:00
Feed back and end of Part I
Attendance Fees
| 1.100 € 1.450 € |
Members of the AGAH, AHPPI, BAPU, Club Phase I, EUFEMED Non-Members |
|---|---|
| 1.900 €
2.500 € |
Part I plus II for Members of the AGAH, AHPPI, BAPU, Club Phase I, EUFEMED Part I plus II for Non-Members |
Special fees for students are available on request
Venue
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 40 30772097
e-Mail: info ( a t ) agah.eu
Web: www.agah.eu
13. Februar 2019 - 15. Februar 2019
Introductory Course in Exploratory Medicines Development – Part I
AGAH Workshop
Oberursel
Deutschland