Course description
Advanced EU Regulatory Affairs
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 participants 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 participants to discuss the implications of Brexit on this subject matter.
Do you work at this organisation and want to update this page?
Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.
Suitability - Who should attend?
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 participants 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.
Outcome / Qualification etc.
- 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
Training Course Content
- Module 1 - An overview of Regulatory Affairs and European / US Legislation
- Module 2 - A review of strategy influences
- Module 3 - The Role of regulatory Affairs
- Module 4 - Understanding Procedure
- Module 5 - The Lifecycle of Products
- Module 6 - The Dossiers – Key Concerns / Examples
- Module 7 - A review of key areas
- Module 8 - Understanding Global Concerns
Course delivery details
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
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5