Gain a strategic insight into the EU regulatory framework and learn how to improve your dossier compilation process
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 and have 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.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
During these sessions students will learn through:
- 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
- Revisiting recorded sessions with unlimited access for 30 days
- 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 within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.
What will you learn?
Efficiency in Marketing Authorisation Applications (MAA)
Efficiency in Marketing Authorisation Applications (MAA)
Speed-up the MAA through effective selection of your drug registration procedure
CTD requirements
CTD requirements
Integrate CTD requirements from the start of your submissions
Handling regulators
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
Post-approval procedures
Maintain your license by performing post-approval obligations on time
Data management
Data management
Improve your dossier compilation process through a systematic data collection strategy
Patents
Patents
Take into consideration the patent situation when working on abridged applications
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.
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
