Pharmaceutical Regulatory Affairs for EU
This live-online masterclass explores key touchpoints across European regulatory systems.
Pharmaceutical Regulatory Affairs for EU
Gain expertise in Pharmaceutical Regulatory Affairs for the EU with our specialized training.
About the Course
In the heavily regulated, rapidly changing environment, staying informed with requirements and guidelines maintained by different authorities is crucial to pharma/biotech players. Complex and challenging, the success in clinical approvals, dossier submission, pharmacovigilance, product filing, among other operations, allow you to accelerate market access and achieve bottom line.
Who Will Benefit
Professionals in the pharmaceutical industry, including regulatory affairs professionals, quality assurance specialists, compliance officers, researchers, and drug developers, will benefit from this Pharmaceutical Regulatory Affairs training focused on the EU. Additionally, professionals from related fields such as clinical research, pharmacovigilance, and medical affairs will find this training valuable for enhancing their understanding of EU regulatory requirements and procedures.
Key Learning Objectives
- Overview of regulatory bodies & competent authorities; EU legislative systems
- Clinical Trial regulations (data requirements, IRB; CTR 2014, ICH GCP; differences within EU)
- Clinical Trial Approval Process
- Product Development regulations (Non-clinical studies vs Clinical studies)
- CTD and eCTD
Run this course in-house
Informa Connect Academy’s customised training solutions have helped organisations deliver tailored learning in different languages to suit every requirement.
Bespoke training designed for your organisation only, combining traditional classroom setting, blended and online learning models
Next Courses
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LEARN MORE ABOUT THIS TRAINING COURSE
Delivered by Dr. Salma Michor
Salma has advised numerous global clients across Pharmaceutical, Medical and Food industries, including J&J, Novartis, Pfizer and Shire and many more.
Run this course in-house
Informa Connect Academy’s customised training solutions have helped organisations deliver tailored learning in different languages to suit every requirement.