Name: Introductory Course on Human Pharmacology / Translational Medicine – Part II
Start: 2014-02-13T00:00:00+01:00
End: 2014-02-15T23:59:59+01:00
Location: AGAH Workshop

13. Februar 2014 - 15. Februar 2014
AGAH Workshop, Heidelberg

Information

Introduction and Learning Outcomes

This course provides a basic training in Human Pharmacology and is addressed to postgraduates in life sciences interested in early clinical development of medicinal products.

Learning Outcomes

On successful completion of Part 2 of this course, students should be able to demonstrate an understanding / knowledge of the following:

integration of pertinent available scientific information into an IB and a clinical trial protocol
specific aspects of how to set-up and conduct early phase clinical trials
defining endpoints for early phase clinical trials
differentiating between primary and secondary endpoints
assessment and evaluation of safety data from clinical trials
GCP / GLP method validation
principles of medical statistics
principles of data management and information flow
molecular basis of drug action
development of biologicals and biosimilars

Day 1: Thursday, 13 February 2014

08:45 – 09:00	Introduction of faculty and participants All
09:00 – 09:15	Overview on Part II training course All
09:15 – 10:45	Pharmacokinetics III: allometric scaling, 14C-studies, absorption half-life, flip-flop kinetics, protein binding, PK linearity / non-linearity, dose proportionality assessments, biopharmaceutics classification system Andreas Kovar
10:45 – 11:15	Break
11:15 – 12:15	Determination of safe starting dose for FIM – case studies Stephanie Plassmann
12:15 – 13:00	Nonclinical toxicology II: reprotoxicology Stephanie Plassmann
13:00 – 14:00	Lunch Break
14:00 – 14:45	Trial protocol and investigator’s brochure – how to integrate information from scientific literature, nonclinical / clinical information and other sources, primary and secondary endpoints Kerstin Breithaupt
14:45 – 16:15	Conduct of clinical trials – SITE SELECTION: contracts, recruitment, auditing – Practical aspects of Phase I studies in patients – Quality management in clinical trials Antje Blank / Katharina Erb-Zohar / Christian Hinze
16:15 – 16:30	Break
16:30 – 18:00	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) Antje Blank / Georg Wensing

Day 2: Friday, 14 February 2014

08:45 – 09:30	Subject informed consent: How to inform healthy subjects and patients about an early phase clinical trial? Kerstin Breithaupt / Antje Blank
09:30 – 10:30	GCP / GLP – focus on method validation: bioanalytics, sample collection, sample preparation, quality assurance procedures Barbara Schug
10:30 – 10:45	Break
10:45 – 11:30	PK/PD trials in drug-device combinations: inhaled glucocorticoids as example for complex early clinical development plans Barbara Schug
11:30 – 13:00	Specific aspects of first-in man trials: FDA and EMA Guidances on FIM; trial medication; examples for typical dose escalation schemes / designs, safety and PK / PD endpoints; when should dose escalation be stopped? Maria Burian / Sybille Baumann
13:00 – 14:00	Lunch Break
14:00 – 15:15	Case study: stop dose escalation or continue dosing? Katharina Erb-Zohar / Maria Burian
15:15 – 16:00	Data management and cleaning, flow of information, reporting Kerstin Breithaupt / Manfred Wargenau
16:00 – 16:15	Break
16:15 – 18:00	Principles of medical statistics: definition of analyses populations (safety, ITT, FAS, PP), principles of statistical testing, statistical significance and power, confidence intervals, ANOVA, ANCOVA, repeated measures, multiple tests, parametric vs. non-parametric analysis, Chi-square, Fisher’s exact) Manfred Wargenau
19:00	Dinner Meeting

Day 3: Saturday, 15 February 2014

08:30 – 10:00	Molecular basis of drug action (receptor pharmacology, agonists, antagonists, second messengers, enzymes, regulatory proteins, transcription factors, cellular sites of drug actions) Martin Coenen / Christoph Coch
10:00 – 10:15	Break
10:15 – 11:15	Introduction to biologicals and biosimilars Hildegard Sourgens
11:15 – 11:30	Break
11:30 – 12:15	Test on Part II contents of Human Pharmacology Training; Please respect regarding travelling arrangements: participation in test is mandatory to receive the certificate of attendance! All
12:15 – 12:30	Feed back All
12:30	End of Part II and Farewell Lunch