Clinical Outcome Assessments

This interactive course is recommended for those who have experience in clinical trials & patient engagement and wish to develop their skills on how PRO measurement is best implemented & sustained to advance patient care.

Data Integrity in Pharma & Biotech

This practical course provides an in-depth understanding of data integrity in a GxP context and brings clarifications on regulatory requirements as well as the examples of common data integrity issues reported by FDA and EU inspections.

Pharmaceutical Cocrystals, Salts & Molecular Modelling

This practical course provides an in-depth understanding of polymorphic and multi-component systems. The series of case studies will bring clarifications on characterization methods as well as on stability evaluation and regulatory requirements.

HTA & Evidence Requirements

This unique course provides a practical & in-depth understanding of HTA decision making across EU markets and will focus on the evidence generation underpinning a convincing value proposition to different HTAs.

Cell & Gene Therapy Products – CMC & Quality Requirements

This unique course provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance &
quality concerns. Join us in Munich and achieve CMC readiness for your cell & gene therapy medicinal products.

Challenges of marketing authorisation and change procedures for generics in 2020

Stability & Shelf Life of Biologics

This 2-day course will provide practical insights into guidance & regulation for stability of biologics with focus on biotech products. Join this course & understand how to apply accelerated and stress stability assessment to predict your product stability.

How To Build A Compliance Program That’s Rightsized For Your Organization

Advanced IVIVC Professional

This course will provide critical insights into various types of IVIVC and practical exercises focused on absorption determination, time scaling, prediction, determination of dissolution limits, case resolution problem from design of studies to utilization of IVIVC.

Digital Quality in Clinical Trials

This unique course provides a practical & indepth understanding of the electronic systems and technologies used in clinical trials, and brings clarifications on global regulation, requirements, compliance & quality concerns.