Training – Scendea

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

Agency Reviewer Training

CMC Course (Chemistry, Manufacturing & Controls)

Introduction to Regulatory Affairs Course

On-Demand Short Courses

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:

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:

On-Demand Short Courses

Flexible online training options delivered via recorded webinars, allowing learners to progress at their own pace.

Advance Regulatory

Regulatory Affairs Training

Comprehensive professional development programs designed to advance your regulatory expertise and career

Professional Regulatory Training Excellence

Expert Instructors

Practical Focus

Flexible Delivery

Our Training Services

Bespoke In-House Training

Key Features:

Target Audience:

Benefits:

Agency Reviewer Training

Key Features:

Target Audience:

Benefits:

CMC Course (Chemistry, Manufacturing & Controls)

Key Features:

Target Audience:

Benefits:

Introduction to Regulatory Affairs Course

Key Features:

Target Audience:

Benefits:

On-Demand Short Courses

Key Features:

Target Audience:

Benefits:

Available Courses:

Free Regulatory Affairs Course

Free

Advance Regulatory

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