Bioassays & Bioanalytical Methods
This practical Bioassays and Bioanalytical Methods online live training is focused on complex therapeutics, such as Biopharmaceuticals, Biologics and Biosimilars.
Effective Project Management for Clinical Trials
This course will focus on honing the skills for excellent Clinical Project Management.
Pharma & Biotech R&D Portfolio Management in the 21st Century
This course is designed for those who already have some experience in R&D project & portfolio management, decision analysis and prioritization, and wish to develop their skills and knowledge in the evolving portfolio management tools, techniques and strategies to maximize value and drive innovation.
Computerized Systems Validation & Data Integrity in Pharma & Biotech
This course is a compilation of topics representing recent challenges related to CSV, and how CSV relates to data integrity assurance.
BA/BE & Biowaivers
This practical course provides an in-depth understanding of BABE design including all practical aspects related to bioavailability & bioequivalence.
New ICH & EMA Quality Guidelines
In summary, this course will help the delegates to identify important new GMP and Regulatory aspects which should be considered throughout the entire life cycle of their specific products and avoid waste of time and money, thereby.
Signal Management in Pharmacovigilance
This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication.
Immunogenicity of Biologics, Biopharmaceuticals & ATMPs
This 2-day course brings practical & in-depth understanding of immunogenicity in pre-clinical and clinical development, and brings clarifications on regulation, requirements, and quality concerns.
Toxicology, ADME & Early Drug Development Plan
Building an Integrated Safety Testing Strategy based on ADME and Toxicology. The purpose of this Toxicology, ADME & Early Drug Development Plan is to understand the concept of a combined ADME-Toxicology approach.
HTA & Evidence Requirements for Pharma & Biotech
A practical & in-depth understanding of HTA decision-making across EU markets with a focus on the evidence generation underpinning a convincing value proposition to different HTAs.
