Consolidate your knowledge of the EU pharmaceutical regulatory framework and streamline dossier compilation for easier submissions

Course Overview

This introductory course will provide you with a grounding knowledge of regulatory affairs in Europe. Upon completion of this course you will have a clear understanding of the EU regulatory structure, including chemical and biological processes. You will also gain a solid grasp of the submission process and the standards required by the regulators.

Through interactive exercises, you will gain a practical insight into the European legal and regulatory environment, the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical approach that will enable you to apply what you have learned to your daily work.

See the full agenda

What will you learn?

Efficiency in Marketing Authorisation Applications (MAA)

Speed-up the MAA through effective selection of your drug registration procedure

CTD requirements

Integrate CTD requirements from the start of your submissions

Handling regulators

Gain faster responses from the regulators through better negotiations and reduce early, or late-stage, setbacks in the registration procedure by anticipating their questions

Post-approval procedures

Maintain your license by performing post-approval obligations on time

Data management

Improve your dossier compilation process through a systematic data collection strategy

Patents

Take into consideration the patent situation when working on abridged applications

Live Online Training

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Students will learn through:

Live interactive sessions
Direct interaction with the trainer during live sessions
Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions two days prior to the course start date. If you have any questions please contact Filippo.Scovasso@informa.com.

Who is this course for?

Those new to Regulatory Affairs or wishing to update their knowledge on European regulatory affairs
Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing, and others)
Regulatory Affairs, Registration, and Documentation Assistants/Officers/Managers
Those in other areas of the pharmaceutical industry such as development or manufacturing
Project Management who would find the knowledge of the regulatory environment useful.

Senior Academic

Alliances Counsel

AstraZeneca

This course provided a very detailed overview of the subject matter. I enjoyed the way the course was delivered, the knowledge and the enthusiasm of the trainer. She was a fantastic teacher and a knowledge sharer.

94%

would attend another live online academy

97%

found the course beneficial to their day to day role

97%

would recommend the course to others