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Orphan, Paediatric and Biologic Medicines Course & Certification
Intermediate
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4.4
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95% Recommended
3 hours
159 active users
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Orphan, Paediatric and Biologic Medicines
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About
Orphan, Paediatric and Biologic Medicines training provides practical, advanced-level knowledge of the regulatory requirements governing orphan, paediatric and biological medicinal products. The course covers orphan designation and incentives, market exclusivity, paediatric investigation plans, waivers and compliance, biological medicines, biosimilars, immunogenicity, advanced therapies and pharmacovigilance.
This Orphan, Paediatric and Biologic Medicines Training Course provides practical understanding of relevant EU and UK regulatory frameworks, guidance and Agency procedures. The course supports professionals in assessing eligibility, selecting appropriate regulatory pathways, understanding development and authorisation requirements, and managing key regulatory obligations throughout the product lifecycle.
Who Should Enrol?
- Regulatory Affairs Professionals
- Regulatory Intelligence Professionals
- Quality Assurance and Quality Control Professionals
- Pharmacovigilance Professionals
- Clinical and Medical Affairs Professionals
- Pharmaceutical Development and Manufacturing Teams
- Market Authorisation and Lifecycle Management Specialists
- Anyone involved in the development, authorisation or regulatory management of orphan, paediatric and biological medicinal products
What you will learn
Understand the fundamentals of orphan, paediatric and biological medicinal products, including orphan designation, eligibility criteria, incentives, market exclusivity and key regulatory principles.
Learn the regulatory requirements for paediatric investigation plans, waivers, modifications and compliance, including submission timelines and the roles of the relevant EU and UK authorities.
Gain practical knowledge of biological medicines and biosimilars, including similarity assessment, analytical and clinical requirements, immunogenicity, tailored clinical development and pharmacovigilance.
Understand EU and UK regulatory pathways for orphan, paediatric and biological medicines, including advanced therapies, centralised authorisation, additional monitoring, market protection and key lifecycle considerations.
Course Syllabus
- The law in force, and the package that is not
- Article 3: two alternatives and one that always applies
- Article 5, the evidence behind it, and the committee
- Designation is not market exclusivity
- Article 8, and the definitions that decide disputes
- Protocol assistance, waivers and the other incentives
- The agreed package, labelled as what it is
- When the obligation bites
- The date the plan is actually due
- Waivers, class waivers and deferrals
- The PDCO and the procedure
- The compliance check
- The two rewards
- PUMA, the stepwise plan and current practice
- The guideline set you actually file into
- The tailored clinical approach
- Extrapolation of indications
- ICH Q5E against a biosimilar application
- Interchangeability, switching and substitution
- One programme, two filings
- The route is not a choice
- The dossier: the process is the product
- Immunogenicity is a programme
- Naming and the batch number
- Additional monitoring is not declinable
- Where an advanced therapy forks
- What to write down, and where this stops
- There is no designation step
- The outcome, without the early signal
- The United Kingdom does have a paediatric plan
- The Windsor Framework, from 1 January 2025
- The International Recognition Procedure
- ILAP, and the gate that closes early
- Day 90, and the route that does not exist
- Restated at the close: what is law, and what is only agreed
- The dated positions this course rests on, and how each is graded
- A dossier that promised an exclusivity designation cannot give
- A plan scheduled for the application, and due at Phase I
- The right permission read as the wrong one, twice over
- A route that does not exist, and obligations treated as options
- A United Kingdom plan built on six assumptions, and six are wrong
- The six items most likely to have moved since verification
- Five Things to Take From This Course
- 📘 Bonus:Orphan, Paediatric and Biologic Medicines eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase — a practical companion guide covering post-approval variations, regulatory classification, submission pathways and lifecycle maintenance, yours to keep forever
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with developments in EU and UK requirements for orphan, paediatric and biological medicines, including changes to legislation, regulatory guidance and Agency procedures, as our training content is continuously monitored, reviewed and updated.
Practical and Risk-Based
The course reflects current EU and UK regulatory practice for orphan, paediatric and biological medicines, enabling learners to apply practical, risk-based regulatory approaches within their own organisation.
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