Introductory Course in Early Medicines Development – Part I
AGAH Workshop, Frankfurt
This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. Two training parts of 2.5 days each 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.
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 | Break |
| 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 – 09:45 |
Pharmacokinetics I: ADME, drug-drug interaction, drug-food interaction, bioequivalence / bioavailability, steady state, accumulation factors
Andreas Kovar |
|---|---|
| 09:45 – 10:00 |
Break |
| 10:00 – 11:15 |
Pharmacokinetics II: pharmacogenetics / polymorphisms, pharmacometrics, PK/PD relationship
Andreas Kovar |
| 11:15 – 12:15 |
Conduct of clinical trials – monitoring
Christian Hinze |
| 12:15 – 12:30 |
Break |
| 12:30 – 13:15 |
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 – 13:45 |
Feed back Part I
Kerstin Breithaupt, Christian Hinze |
| 13:45 – 14:30 |
Farewell Lunch and end of Part I |
Attendance Fees
| 1.100 € 1.450 € |
Members of the AGAH, BAPU, Club Phase I, AHPPI, DGPharMed, DGKliPha Non-Members |
|---|---|
| 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
Contact
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 ) csihamburg.de
Venue
DAS SPENERHAUS
Hotel und Tagungszentrum am Dominikanerkloster
Dominikanergasse 5
60311 Frankfurt am Main
17. February 2015 - 19. February 2015
Introductory Course in Early Medicines Development – Part I
AGAH Workshop
Frankfurt
Deutschland