
Introductory Course on Human Pharmacology / Translational Medicine – Part II
AGAH Workshop, Heidelberg
This course provides a basic training in Human Pharmacology / Translational Medicine and is addressed to postgraduates in life sciences interested in early clinical development of medicinal products.
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 |
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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 |
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 |
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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 |
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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 |
Attendance Fees
1.250 € | Non-Members |
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1.000 € | Member of the AGAH, DGPharMed, DGKliPha, BAPU, Club Phase I, AHPPI |
750 € | Students |
This meeting is accredited by the Landesärztekammer, participants will be awarded ”Fortbildungspunkte”.
Contact
Registration | Workshop Office:
CSi Hamburg GmbH
Falkenried 88
D-20251 Hamburg
Phone: +49 40 307720 97
Telefax: +49 40 846097 60
E-Mail: agah-veranstaltungen ( a t ) csihamburg.de
Venue
Seminarzentrum und Gästehaus der SRH Business Academy GmbH Bonhoefferstraße 12 69123 Heidelberg
Registration
May we please ask you to use the registration form.
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13. February 2014 - 15. February 2014
Introductory Course on Human Pharmacology / Translational Medicine – Part II
AGAH Workshop
Heidelberg
Deutschland