Quality & Regulatory Requirements for Biosimilars in the EU

Quality & Regulatory Requirements for Biosimilars in the EU Training Course | Fleming

The Quality & Regulatory Requirements for Biosimilars in the EU online live training aims to create a deeper understanding of why biotechnological products – and as a consequence biosimilars – are a unique product category and what aspects have to be considered in R&D and Drug Regulatory Affairs.

Signal Management in Pharmacovigilance

Signal Management in Pharmacovigilance Training Course | Fleming

This practical Signal Management in Pharmacovigilance online training provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.

Pharmacovigilance Inspections & Audits Updates

Pharmacovigilance Inspections & Audits Updates Training Course | Fleming

This course will provide a comprehensive, yet practical introductory guide to pharmacovigilance audits and inspections best practice to help navigate what is required to demonstrate compliance.

Data Integrity in Pharma & Biotech

Data Integrity in Pharma & Biotech Training Course | Fleming

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

Advanced IVIVC Professional

Advanced IVIVC Professional Training Course | Fleming

Join Advanced IVIVC Professional
online live training to understand the selection of most appropriate data to establish IVIVC.

Clinical Outcome Assessments

Clinical Outcome Assessments Training Course | Fleming

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 to advance patient care.