Regulatory Affairs Training
Comprehensive professional development programs designed to advance your regulatory expertise and career
Professional Regulatory Training Excellence
Through our partnership with Entry to Regulatory, we offer comprehensive training programs designed by industry experts with extensive regulatory experience. Our courses combine theoretical knowledge with practical, real-world applications to accelerate your regulatory career.
Expert Instructors
Learn from former agency reviewers and industry professionals with 10+ years experience
Practical Focus
Real-world case studies, hands-on exercises, and work experience components
Flexible Delivery
On-site, virtual, and on-demand options to fit your schedule and learning preferences
Our Training Services
Comprehensive range of regulatory affairs training programs tailored to different experience levels and learning needs
Bespoke In-House Training
Fully customized, on-site regulatory affairs training courses designed to meet the specific needs of your organization.
Key Features:
- Full customization of course content and duration
- Expert instructors with prior agency experience
- Flexible delivery - on-site or virtual
- Post-course mentoring and online resource access
- Tailored to your pipeline and therapeutic areas
Target Audience:
Organizations seeking to upskill regulatory teams at various professional levels
Benefits:
- Cost savings of up to 40% compared to external training providers
- Resource savings: Train entire teams simultaneously reducing individual training costs
- Time savings: 60% faster skill development through targeted, relevant content
- Real-world case studies and practical insights
- Customized to specific regulatory challenges
Agency Reviewer Training
Specialised training for Health Authority reviewers for the assessment of various types of regulatory submissions based on expert EU and UK assessment principles.
Key Features:
- Taught by a former MHRA assessor
- Product focused assessment training e.g. cell and gene therapy products
- Principles of assessment with practical examples
- Creating requests for information and executing scientific advice meetings effectively
- Real-world examples from MHRA, EMA and FDA practice
Target Audience:
Health Authority professionals
Benefits:
- Cost savings: Reduce assessment time by up to 30% through enhanced reviewer efficiency
- Resource savings: Optimize allocation of assessment resources across multiple submissions
- Time savings: Accelerate review timelines by 25% through improved assessment methodology
- Quality improvements: 40% reduction in post-assessment queries through enhanced evaluation skills
- Training cost savings: Up to 50% cost reduction compared to external training providers
- Comprehensive benefit-risk assessment understanding
CMC Course (Chemistry, Manufacturing & Controls)
Comprehensive CMC training integrated into regulatory affairs education, covering drug substance and drug product requirements.
Key Features:
- eCTD Module 3 content and structure
- Quality and CMC requirements for both drug substance and product
- MAA authoring including QP declaration
- EU variations classification including CMC variations
- Strategic and operational CMC guidance
Target Audience:
Regulatory professionals needing CMC knowledge as part of comprehensive regulatory training
Benefits:
- Complete understanding of quality requirements
- Practical CMC case studies
- From early development through post-approval
- Integration with overall regulatory strategy
Introduction to Regulatory Affairs Course
Flagship comprehensive course providing extensive regulatory knowledge, practical work experience, and job search support.
Key Features:
- 40+ CPD hours covering EU, UK & US regulations
- 4 weeks part-time with on-demand recordings
- 1 month part-time work experience/internship
- Job search mentoring until employment secured
- Expert CV review and mock interviews
- Industry-recognised certificate
Target Audience:
Professionals seeking to transition into regulatory affairs or gain knowledge and/or experience in EU, US or UK regulatory submissions
Benefits:
- Comprehensive training on EU, UK & US regulations
- Practical work experience component
- Job placement support and mentoring
- Multiple successful student placements at GSK and other companies
On-Demand Short Courses
Flexible online training options delivered via recorded webinars, allowing learners to progress at their own pace.
Key Features:
- Self-paced learning with flexible scheduling
- Certificate upon completion
- Recorded webinars can be revisited multiple times
- Large library of training topics
- Courses to fit all budgets
Target Audience:
Professionals seeking specific online regulatory knowledge in targeted areas
Benefits:
- Learn at your own pace and schedule
- Customise your regulatory learning
- Cost-effective compared to in-person training
- Lifetime access
- Industry recognised certification
Available Courses:
Ready to Advance Your Regulatory Career?
Join hundreds of professionals who have enhanced their regulatory expertise through our comprehensive training programs.
Why Choose Our Training Programs?
Industry-Recognized Certification
Receive CPD hours and certificates recognized across the pharmaceutical industry
Regulatory Affairs Work Experience
Gain practical regulatory affairs work experience through our comprehensive programs
Career Support
Job search mentoring, CV reviews, and interview preparation included
Training Partnerships
Entry to Regulatory
Official Training Partner
Our training programs are delivered through Entry to Regulatory
Visit Entry to Regulatory