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Informa
Starting TBC in 2021

LIVE Online Academy - 5 Sessions

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.

Delegates of our live online academies said...

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