Course description
Advanced European 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 3-day 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 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.
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Suitability - Who should attend?
This training programme is aimed at professionals specialising in Regulatory affairs within the pharma industry, including:
- Regulatory Affairs Manager
- Strategy Management
- Regulatory Affairs Officer
- Quality Manager
- Regulatory Affairs Specialist
- Regional Coordinator
- Regulatory Affairs Associate
- Development Pharmacist
- Pharmacovigilance Manager
- Regulatory Affairs Attorney
- Regulatory Affairs Executive
- Project Managers
Outcome / Qualification etc.
- Gain advanced tools necessary to optimise and maintain
your regulatory procedures - Latest changes in legislation
- Facilitate improvement in your review and maintenance
procedures - Improve your day-to-day management of regulatory affairs
- Identify common problems and solutions through open
discussions - Learn to traverse the minefield of European regulatory
affairs
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
Reviews
Expenses
The cost of this training course is £1995 + VAT per participant, which covers tuition and course materials.
In-house Training
PTI - Pharmaceutical Training International can also deliver this course as in-house training for your company. You can reduce costs, enhance accessibility to training resources and better address your company’s own business goals with a tailored PTI training package.
“It was a very thought provoking course.” Regulatory Affairs Manager, Mundipharma