Quality & Regulatory Requirements for Biosimilars in the EU
The training aims to create deeper understanding 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.
Advanced IVIVC Professional
Join Advanced IVIVC Professional training to understand the selection of the most appropriate data to establish IVIVC.
Annex 1
Attention is given by the regulators and inspectors in this field, which generally is considered as a technology of pharmaceutical manufacturing with immanent high risk.
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.
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.
Digital Health Market Access
The purpose of this Digital Health Market Access online live training is to understand pricing and market access for digital health technologies in the US, UK, and China.
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.
EU Pharmacovigilance & PRAC Procedures
This EU Pharmacovigilance and PRAC Procedures training course will provide a unique insight into the functioning of the EU Pharmacovigilance Risk assessment Committee (PRAC) and advice on how to best interact with this important committee.
Digital Ethics, Compliance & Data Privacy in the Pharmaceutical Industry
This practical course helps you to explore a bridge between the troubled waters of legal compliance and the use of rapidly evolving untested technology in the healthcare industry.
Advanced Good Distribution Practices Refresher Training
Gain an in-depth understanding of the pharmaceutical directives and
guidelines related to GDP for Medicinal Products within the Supply Chain.
3D Printing of Solid Dosage Forms & Medical Devices
Join our 3D Printing of Solid Dosage Forms & Medical Devices
training to learn about recent developments in printable solid dosage forms and medical devices.
Clinical Project Management to Advance your Clinical Programs
This Clinical Project Management to Advanced your Clinical Programs online live course will focus on honing the skills for excellent Clinical Project Management.
Data Integrity in Pharma & Biotech
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.
