European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop: Integrating pharmacogenomics early into drug development: pharmacokinetics as a working example

• Date:
  Samedi, 20 décembre 2008, Journée Entière
• Lieu:
  European Medicines Agency, Amsterdam, the Netherlands

Documents

Agenda - European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop: Integrating pharmacogenomics early into drug development: Pharmacokinetics as a working example

Presentation - European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop: Integrating pharmacogenomics early into drug development: Pharmacokinetics as a working example

Presentation - Applications of pharmacogenomics in pharmacokinetics at the European Medicines Agency: Experience and expectations

Presentation - Pharmacogenomics in early drug development: Industry's view

Presentation - Applications of pharmacogenomics in pharmacokinetics at the Pharmaceuticals and Medical Devices Agency: Experience and expectations

Presentation - Application of pharmacogenomics in pharmacokinetics at the Food and Drug Administration: Experience and expectations

Presentation - Gaining consensus on emerging science: The Absorption, Distribution, Metabolism and Excretion Panel as an exemplar

Presentation - Pharmacokinetics and pharmacogenomics: Building blocks for the cases in session 3

Presentation - Case 1: Pharmacogenomic design in phase I based on in-vitro data

Presentation - Case 3: Integrating pharmacogenomics early into drug development: Pharmacokinetics as a working example

Presentation - Case 4: Integrating pharmacogenomics early into drug development: Pharmacokinetics as a working example

Presentation - Core data set: CYP2D6 metabolism

Presentation - Phase 2a trial design is being planned: How does pharmacokinetic variation observed in phase I affect trial design?

Presentation - Pharmacogenomic data submission to biomarker scientific advice: Task: What does the team do next?

Presentation - Case 4: Goal: What does team plan for phase 2b trial?

Application of PGx in PK in medical practise: How does PGx inform decisions? - Munir Pirmohamed

Report on the EMEA/EFPIA Pharmacogenetics Workshop on Integrating Pharmacogenetics Early into Drug Development: PK as a working example

Reference Number: EMEA/151623/2009