Name: Introductory Course in Exploratory Medicines Development – Part I
Start: 2017-11-29T00:00:00+01:00
End: 2017-12-01T23:59:59+01:00
Location: AGAH Workshop

29. November 2017 - 1. Dezember 2017
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

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, 29 November 2017

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, 30 November 2017

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
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

Day 3: Friday, 01 December 2017

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 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

Attendance Fees

1.100 €
1.450 €

Members of the AGAH, BAPU, Club Phase I, AHPPI, DGPharMed, DGKliPha
Non-Members

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

29. November 2017 - 1. Dezember 2017

Introductory Course in Exploratory Medicines Development – Part I

AGAH Workshop

Oberursel
Deutschland

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Introductory Course in Exploratory Medicines Development – Part I

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

Introductory Course in Exploratory Medicines Development – Part I