Being a regulatory affairs professional in a pharmaceutical or biotech company is both challenging and rewarding. As a senior professional you must ensure compliance for all new and existing products at the same time as managing budgets and keeping to business-critical deadlines. Regulatory affairs leaders must think strategically, aligning their regulatory knowledge to the wider organisational goals and objectives.
This course will examine the current European legislation and help you to understand the consequences for Regulatory Affairs Managers. You will take a strategic approach to regulatory affairs on a variety of topics such as clinical regulations, pharmacovigilance, submissions, labelling, manufacturing, and lifecycle management. Crucially you will assess the role of management as a regulatory professional. You will also compare the regulatory requirements in Europe with the rest of the world.
Once completed delegates will be fully up-to-date with the latest legislation and be equipped with the knowledge and confidence to instigate the optimisation of in-house regulatory procedures.
There will also be additional time for delegates to discuss the implications of Brexit on this subject matter.
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 8 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 firstname.lastname@example.org.
What will you learn?
Overview of current European regulation and recent developments
The role of regulatory affairs management
Procedure review of CTD and eCTD
Familiarise yourself with pharmacovigilance regulations and challenges
Understand labelling compliance in Europe and globally
Control and management for manufacturing and quality control overview
Advanced product lifecycle management
Who is this course for?
This course is designed for regulatory affairs professionals at management or higher level with over two years’ experience, or lawyers specialising in European regulatory affairs. Ideally, the delegates would have previously (minimum of two years) completed the Introduction to European Regulatory Affairs Course by PTI and or the Regulatory Affairs Strategies course also by PTI.
This course aims to provide the delegate with the tools to optimise and maintain their current in-house procedures. It also aims to provide the knowledge needed to keep up to date with new legislations.
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.