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. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.
Over 5 sessions students will learn through:
- Live interactive bitesize 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
- 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.
