Virtual Training

Key Topics:

• Introduction

• General requirements for biostudies

• A dissolution chemists view on drug absorption

• Establishing biostudy statistical design

• Developing dissolution tests-QA and setting specifications

• Similarity, comparability and correlation

• The predictive power of dissolution and alternatives to full bioequivalence

• Requirements of GMP and GCP as applied to Bioequivalence

Who should attend?

• BA/BE managers

• Regulatory affairs professionals 

• Pharmacokineticists

• Dissolution testing specialists 

• IVIVC specialists

• Formulation managers

• Solid dosage formulators

Trainer:

Doctor in Pharmacy by the University of Navarra with a PhD in cardiovascular pharmacology. MSc in Clinical Research by the University of Cardiff. MBA by the Barcelona School of Managment (U Pompeu Fabra).

More than 10 years of experience in managing projects in an international setting, including subcontracted studies and leadership of a team of 5. Interaction with internal and external experts. Participated in scientific advice meetings with regulatory authorities and in official inspections.

Leadership of the definition and implementation of a GCP system in accordance with EU and FDA requirements, whilst maintaining deadlines and reducing costs. Created and implemented a procedure for cooperation between the pharmacokinetic, pharmaceutical and analytical groups.