Combination Products Regulations and Requirements Course

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The distinction between pharmaceuticals and medical devices has become increasingly blurred, giving rise to Combination Products that merge aspects of both. This one-day training programme is designed for professionals with responsibilities in developing, producing or registering Combination Products and it provides a clear overview of the regulatory landscape and agency expectations in both the US and Europe. Delivered by expert tutors, the course ensures learners gain a practical skills and excellent understanding of the specific regulatory requirements they must address in their roles.

We can tailor the training to meet your specific training needs and incorporate examples from your processes and procedures into the training programme as required.

This programme offers a comparative and practical exploration of EU and US requirements for Combination Products. Learners gain clear insights into the regulatory pathways and the quality system obligations of each sector.

Key topics include:

Introduction to Combination Products regulation
Applicable regulations and guidance documents
CE marking and medical device classification
Registering a medical device in the US
Registering a pharmaceutical product in the EU
Registering a pharmaceutical product in the US
Differences between medical device and pharmaceutical quality systems
Medical device design controls
Pharmaceutical and medical device vigilance
Roles and responsibilities of involved parties
Practical exercises and discussions

The training involves practical exercises covering all relevant topics, with learners encouraged to work on examples from their own workplace as part of these practical exercises. If required, content may be tailored to reflect your organisation’s specific processes, risk profile and regulatory setting.

This training programme is designed for professionals in both pharmaceutical and medical device sectors who are engaged in the development, production, validation or registration of Combination Products.

The training is particularly beneficial for:

R&D Product Development Engineers and Managers
Quality Assurance personnel
Regulatory Affairs professionals
Supply Chain Specialists
Sales staff supporting regulated products

A good standard of written and spoken English is important to engage effectively with this programme.

On successful completion of this course, learners will be able to:

Define Combination Products under EU and US regulations
Identify and interpret key regulations, harmonised standards and guidance documents
Explain the process for CE marking in Europe
Describe US medical device registration requirements
Outline EU pharmaceutical registration processes
Outline US pharmaceutical registration processes
Compare medical device and pharmaceutical quality system requirements (FDA 21 CFR Part 820, ISO 13485, Part 210/211, EU GMP Vol 4)
Summarise requirements for design controls and 21 CFR Part 4
Explain vigilance and post-market surveillance obligations
Clarify responsibilities of involved parties in different product scenarios
Apply practical knowledge to manage outsourced Combination Product responsibilities

These outcomes ensure that learners return with the practical skills and knowledge necessary to navigate regulatory pathways and support compliance for Combination Products.

This course is delivered by leading specialists in life sciences regulation. Each tutor brings a wealth of industry experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support.

Our tutors provide continuous guidance throughout the training, ensuring that learners gain both technical understanding and practical application.

Gerry Burke

Gerry is a self-motivated medical industry professional with kn...

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John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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Our training approach is practical, highly interactive and discussion-based, with flexibility to meet organisational needs

Pre-training consultation for in-company courses to tailor content to organisational needs
Emphasis on industry specific application through practical exercises, case studies and group activities that reinforce key concepts and encourage active participation.
Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance.
Live training is available virtually or delivered onsite to suit the needs of the team
Real-time support from expert tutors

Class sizes are generally limited to 12-15 participants to support personalised learning and individual support.

Learners who complete this course often continue to deepen their skills in:

Pharmaceutical Quality Risk Management and ICH Q9
Software Validation
21 CFR Part 11 Electronic Records and Electronic Signatures and Data Integrity
ISO 13485:2016 & The Medical Devices Regulation (CE Marking Process)
Technical Writing Skills

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Snapshot

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Course Code

LS042

Duration

1 training day

Delivery Mode

This programme is delivered by or In-Company training

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