CMC Analytical Comparability: Methods & Strategies for Biologics

TRAINING CMC Analytical Comparability: Methods & Strategies for Biologics 21- 22 October 2020 Vienna, Austria Day Hour Minute Second Analytical Comparability of Biologics, Biosimilars & Biobetters Comparability in Biologics Development The analytical strategies of protein characterization of Biologics & Biosimilars Online Live Training Features Virtual breakout rooms for workshop tasks & exercises Live discussions Chat … Continued

Data Science & AI in Pharma & Healthcare

This 3-day online live course is intended to expose participants to data science and AI best practices in the Pharmaceutical & Healthcare industry and introduce the big data ecosystem and how it can benefit from AI.

EU Pharmacovigilance & PRAC Procedures

This interactive course is recommended for those who have some experience in pharmacovigilance and wish to develop their skills to enhance the safe & effective use of medicines.

Monoclonal Antibodies

This unique 3-days course is designed for advanced persons & specialists in the field of protein therapeutics or participants who have emphasis to jump into this new business field.

Medical Devices Post-Market Surveillance

The new Medical Devices Regulation has provided a radical shake up of requirements for medical devices. It is arguable that the Post-Market Surveillance elements have not changed much, but the prescriptive nature of those elements in the Regulation leaves the current approach of most manufacturers falling short of the law. The new requirements tie Post-Market Surveillance to Risk analysis, Clinical Evaluation and Vigilance. This means that nothing short of a joined-up approach will be acceptable in the future.

Clinical Project Management

The pharmaceutical industry is aware that the International Council for Harmonisation is planning to merge the guidelines for Good Clinical Practice (E6) and General Considerations for Clinical Trials (E8). To prepare for this change in 2022 it behoves all clinical trial professions to ensure they are working to the latest expectations when managing their clinical programmes.

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.