EUFEMED and its member associations, including Healixia, are developing a modular training course in Human Pharmacology, leading to qualifications at the certificate and diploma levels. The training courses are intended for physicians, biopharmaceutical scientists and healthcare professionals working in early phase clinical research and would also suit investigators intending to fulfill the role of Principal Investigator for First in Human (FIH) trials.

Healixia/EUFEMED Certificate Course in Human Pharmacology - Module 4

This course addresses postgraduates in life sciences interested in early clinical development of medicinal products. The training provides an overview on pharmacokinetics (PK), pharmacodynamics (PD) and biomarkers in early clinical drug development spanning from non-clinical pharmacology over first-in-man studies to proof-of-concept clinical trials.

The course takes place in Belgium in 2 parts:

• Part 1: Principles of Pharmacokinetics (15-16-17 January 2025) in KU Leuven
• Part 2: Principles in Pharmacodynamics  (2-3 April 2025) in UGent

Learning Outcomes

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

• Principles of PK including qualitative (ADME) and quantitative aspects (e.g. half-life, volume of distribution, clearance);
• PK after single and multiple dosing including drug accumulation, dosing regimens and study design;
• Concepts of therapeutic drug monitoring;
• PK: small molecules versus biologicals and ATMPs;
• Bioavailability and bioequivalence (generic drugs versus biosimilars);
• Population pharmacokinetics;
• Principles of PD: receptor binding, concentration-effect relationship;
• How to present PK and PD data;
• Extrinsic and intrinsic factors affecting PK and PD;
• Drug interactions;
• Pharmacogenetics / pharmacogenomics;
• Pharmacokinetic / pharmacodynamic models;
• The choice of formulations depending upon the characteristics of the compound and the intended uses of the product;
• The principles of testing formulations for bioequivalence, including the concept of biosimilar formulations;
• Biomarkers for target engagement, efficacy and safety;
• Strategies how to derive the first human dose (concepts of MRSD and MABEL);
• Dose escalation scheme;
• Stopping rules;
• PK / PD input in Investigator's Brochure (IB);
• Concept of Pediatric investigational Plan (PIP);
• Scientific rationale for genomic and related analyses;
• Pharmacometrics: PB-PK, PK-PD, model informed drug development.

Exercises / applications:

As part of the course, assignments will be provided to be prepared at home. These assignments will subsequently be discussed in group sessions in order to learn from them as much as possible. The assignments comprise of: interpretation of preclinical PK data, calculation of the MRSD and dose escalation scheme, calculation of PK parameters based on raw PK data from a FIH trial.

Based on these practical exercises the participants will develop a thorough understanding of how to interpret and calculate PK data; he/she will be able to apply the theoretical knowledge acquired by attending the course.

Faculty members

• Karel Allegaert, KU Leuven
• Pieter Annaert, KU Leuven
• Pieter De Cock, Ugent
• Jan de Hoon, KU Leuven
• Erwin Dreesen, KU Leuven
• Stephan Glund, Boehringer Ingelheim
• Erik Mannaert, Johnson & Johnson
• Sylvie Rottey, Ugent
• Isabel Spriet, KU Leuven
• An Vermeulen, UGent - Johnson & Johnson

Pre-training documentation

• ICH Guideline M3(R2):
  • Guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals (December 2009).
• EMA guideline:
  • EMEA/CHMP/28367/07 Rev.1: Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicine products (2017).
• FDA guidance for industry:
  • Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers (July 2005).

Tickets

Member tickets are available for members of: Association of Human Pharmacology in the Pharmaceutical Industry (AHPPI - UK), Healixia (Belgium), Association Française de Pharmacologie Translationnelle (AFPT – France), Association for Applied Human Pharmacology (AGAH - Germany), Associatie van Contract Research Organisaties in Nederland (ACRON - Netherlands), and Polish Federation for Early Medicines Development (Polfemed - Poland)