Loading Events

Introductory Course in Exploratory Medicines Development – Part I

13. February 2019 - 15. February 2019
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. February 2019 - 15. February 2019

Introductory Course in Exploratory Medicines Development – Part I

AGAH Workshop


Oberursel
Deutschland