Combination Products (Drug-Device) Course & Certification

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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.

Receive a personal certificate to show your subject knowledge on course completion.

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

You will stay up to date with the current combination-product frameworks and their fundamental divergence across jurisdictions: US 21 CFR Part 3 (the 3.2(e) definition, primary mode of action, Office of Combination Products assignment and the RFD/Pre-RFD process); 21 CFR Part 4 Subpart A (the streamlined single-QMS cGMP approach) and Subpart B (postmarketing safety reporting); the FDA QMSR final rule, under which 21 CFR 820 now incorporates ISO 13485:2016 by reference and Part 4 received conforming amendments with no new cGMP obligations, effective 2 February 2026; relevant FDA Office of Combination Products guidances; EU Directive 2001/83/EC and the marketing-authorisation framework; EU MDR (Regulation (EU) 2017/745), including Article 117 and the Notified Body Opinion on the device part's conformity with the Annex I GSPRs for new applications from 26 May 2021; MDCG guidance on drug-device combinations; and the device standards ISO 13485, ISO 14971, IEC 62366-1 and ISO 10993 — as our training courses are constantly monitored, reviewed and updated. Every statement is labelled with its jurisdiction (US or EU) and document type (law, guidance or standard); positions were verified in July 2026 and must be re-verified against the source, for the relevant jurisdiction, before use.

The course content is Whitehall Training editorial material, developed to reflect established combination-product regulatory practice across the device and pharmaceutical disciplines — how these products are actually classified, how a pathway is chosen and defended, and the failure modes that appear when the US and EU systems are merged or a jurisdiction is left unstated. It is built around a single fictional case study, Helix Vitalis and its Immunopen integral autoinjector and prefilled-syringe variant intended for both markets, so that every classification, PMOA, cGMP, postmarketing, EU-pathway, Article 117, human-factors and change-control decision is one the learner can reason through. Laws, regulations, guidance and standards are paraphrased and section-referenced; they are never reproduced, and nothing in the course is legal or regulatory advice or a regulator endorsement.