
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.
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).
09:00 – 09:30 | Introduction of faculty and participants | |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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18:30 – 20:30 | Get together: formation of break-out groups |
08:45 – 10:15 | 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 |
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10:15 – 10:30 | Break |
10:30 – 11:00 | Conduct of clinical trials: Site selection
Katharina Erb-Zohar |
11.00 – 12:15 | Conduct of clinical trials (including case study): Practical aspects in planning of early phase trials
Sybille Baumann |
12:15 – 13:00 | Conduct of clinical trials: Subject / patient informed consent in early phase clinical trials Kerstin Breithaupt-Grögler |
13:00 – 14:00 | Break |
14:00 – 15:45 | 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 |
15:45 – 16:00 | Break |
16:00 – 16:30 | Conduct of clinical trials: Independent data monitoring committee Katharina Erb-Zohar |
16:30 – 18:00 | 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 Barbara Schug |
Evening | Please prepare homework for Day 3 |
08:45 – 09:00 | Discussion of homework: case studies: AE/SAE documentation, set-up of a FIH / a BE trial
Kerstin Breithaupt-Grögler |
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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
Barbara Schug |
14:45 – 15.00 | Break |
15:00 – 16:00 | Bioequivalence trials: How to do it right – planning a successful BE trial
Barbara Schug |
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 |
1.100 € 1.450 € |
Members of the AGAH, BAPU, Club Phase I, AHPPI, DGPharMed, DGKliPha Non-Members |
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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
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
This workshop is supported by PreClinical Safety (PCS) Consultants Ltd.
CSi Hamburg GmbH
Conferences | Symposia | Incentives
Goernestraße 30
20249 Hamburg
Germany
phone: +49 40 30770300
fax: +49 40 30770301
e-Mail: agah-veranstaltungen ( a t ) csihamburg.de
May we please ask you to use the registration form.
29. November 2017 - 1. Dezember 2017
Introductory Course in Exploratory Medicines Development – Part I
AGAH Workshop
Oberursel
Deutschland