What does EU and global regulatory training cover?

EU and global regulatory training covers the regulations, guidelines, authorities and compliance expectations that professionals encounter when working with products across European and international markets. Topics can include EU regulatory requirements, EMA, MHRA, EU MDR, ICH guidelines, regulatory submissions and global regulatory strategy.

Which EU regulations should pharmaceutical professionals understand?

Pharmaceutical professionals working in the EU may need to understand European regulatory frameworks, EMA processes, applicable EU legislation, ICH guidelines, GMP requirements and expectations surrounding regulatory submissions and compliance.

What is the difference between EMA and national European regulatory authorities?

EMA coordinates scientific evaluation and regulatory activities at EU level for applicable medicines, while national competent authorities have responsibilities within individual European countries. The applicable regulatory route determines how EMA and national authorities are involved.

What should I know about EU MDR if I work in medical devices?

Medical device professionals may need to understand EU MDR requirements covering device classification, conformity assessment, technical documentation, clinical evaluation, quality management systems and post-market surveillance. In vitro diagnostic devices are regulated separately under IVDR.

Why are ICH guidelines important for global regulatory work?

ICH guidelines help harmonize technical and regulatory expectations across major pharmaceutical markets. They cover areas including quality, safety, efficacy and multidisciplinary regulatory requirements and support more consistent approaches to development and submissions.

What regulatory training is useful for professionals working on global submissions?

Training in regulatory strategy, CTD and eCTD structure, ICH guidelines and regional differences between major markets can help professionals understand global submissions and distinguish common requirements from region-specific requirements.

Is EU regulatory training useful if I work outside Europe?

Yes. Companies developing or selling products for the EU market need to understand applicable EU requirements regardless of where their teams are located. EU requirements can also influence broader international regulatory strategies.

Who should take EU regulatory training?

Regulatory Affairs, Quality Assurance, Regulatory Compliance, Clinical and GxP professionals in pharmaceutical, biotechnology and medical device organizations can benefit from EU regulatory training, as can consultants and professionals supporting European regulatory activities.

What is the difference between EU MDR and IVDR?

EU MDR governs medical devices, while IVDR governs in vitro diagnostic medical devices. Both establish requirements for areas such as classification, technical documentation, conformity assessment and post-market surveillance, but they apply to different types of devices.

What is included with a TalkFDA recorded course?

TalkFDA recorded courses provide access to the course content and learning materials included with the individual program. Course-specific details, including the topics covered and available resources, are provided on each course page.

Are TalkFDA courses live or recorded?

TalkFDA offers recorded courses that professionals can access and complete at their own pace. Course availability and format are specified on the individual course page.

Can I take a recorded course after the live program has ended?

Yes, when a live program is made available as a recorded course, professionals can access the recorded learning content after the live program has ended, subject to the availability and access terms shown on the course page.

EU & Global Regulatory Training Courses

Q: How do I choose the right EU regulatory training course?

Choose a course based on your role, product type and the markets you work in. Regulatory Affairs professionals may need submission and lifecycle management training, Quality professionals may need GMP and quality-system content, and medical device professionals may need EU MDR or IVDR training.

Build practical knowledge of European and international regulatory requirements with TalkFDA courses covering EU regulations, global regulatory strategy, ICH guidelines, pharmaceutical and medical device requirements, and regulatory compliance.

Regulatory requirements vary across regions, but many pharmaceutical, biotechnology, medical device and life sciences organizations operate across multiple markets. Understanding how European, UK and international regulatory frameworks work together is essential for professionals involved in regulatory affairs, quality, compliance, submissions and product development.

TalkFDA's EU & Global Regulatory Training covers key regulatory concepts, authorities, guidelines and compliance expectations across major international markets. Learn about EU regulatory requirements, EMA and MHRA expectations, EU MDR, ICH guidelines, global submissions and other topics that support effective regulatory decision-making.

Explore courses designed to help professionals understand regulatory requirements and apply them to their day-to-day responsibilities.

EU Regulatory Affairs & Strategy
EMA & Pharmaceutical Regulation
EU MDR & Medical Devices
ICH Guidelines & Harmonization
UK & MHRA Requirements
Global Regulatory Compliance

Regulatory Affairs professionals managing European or international requirements
Quality Assurance and Regulatory Compliance professionals
Pharmaceutical and biotechnology professionals
Medical device professionals working with EU MDR and international requirements
Professionals involved in regulatory submissions and product registration
Clinical and GxP professionals working with international requirements
Consultants, auditors and compliance professionals
Managers responsible for regulatory or quality activities

Understand European regulatory frameworks, regulatory pathways, submissions and strategic considerations for pharmaceutical, biotechnology and life sciences products.

Explore European pharmaceutical regulatory requirements, EMA processes, regulatory expectations and key considerations for product development and compliance.

Learn about EU MDR requirements, medical device compliance, technical documentation, regulatory pathways and related quality and regulatory responsibilities.

Understand how ICH guidelines support harmonized approaches to pharmaceutical development, quality, safety, efficacy and regulatory submissions.

Build an understanding of UK regulatory requirements and MHRA expectations relevant to pharmaceutical, medical device and life sciences professionals.

Explore regulatory requirements across international markets and develop a broader understanding of global submissions, compliance and regulatory strategy.

EU and global regulatory training teaches the laws, guidelines and procedures that govern how medicines and medical devices are developed, approved and monitored in Europe and worldwide. Typical topics include EU marketing authorisation routes, the roles of EMA and national authorities, EU MDR and IVDR, ICH guidelines, CTD/eCTD submissions, GMP and global regulatory strategy.

Pharmaceutical professionals working in the EU should understand Directive 2001/83/EC, Regulation (EC) No 726/2004, the Clinical Trials Regulation (EU) No 536/2014, the variations framework and EU GMP (EudraLex Volume 4). Regulatory Affairs teams focus mainly on marketing authorizations and variations, while Quality teams focus on GMP and inspections.

EMA coordinates the scientific evaluation of medicines at EU level, while national competent authorities regulate medicines within their own countries. Under the centralised procedure, EMA's CHMP issues an opinion and the European Commission grants one EU-wide authorisation. Under the decentralised and mutual recognition procedures, national authorities lead the assessment. National authorities also handle inspections and national-only products.

EU MDR (Regulation (EU) 2017/745) requires manufacturers to classify their devices, complete conformity assessment (usually with a notified body), maintain technical documentation, perform clinical evaluation, operate a quality management system and carry out post-market surveillance. In vitro diagnostics are covered separately by IVDR (Regulation (EU) 2017/746).

ICH guidelines harmonise technical requirements across major markets, so companies can generate one body of data accepted by multiple regulators. They are grouped into Quality (Q), Safety (S), Efficacy (E) and Multidisciplinary (M) series. Examples include Q9 (quality risk management), Q10 (pharmaceutical quality system), E6 (Good Clinical Practice) and M4 (the Common Technical Document).

Training in regulatory strategy, CTD/eCTD structure, ICH guidelines and regional differences between the EU, US, Japan and other markets is most useful for global submissions. The CTD format lets teams build one core dossier and adapt it regionally, mainly through Module 1, so understanding what is common and what is region-specific is the key skill.

Yes. Any company that sells or develops products for the EU market must meet EU requirements, wherever its teams are based. For example, marketing authorization holders for medicines must be established in the EEA, and non-EU medical device manufacturers must appoint an EU authorized representative under MDR. EU rules also shape many global regulatory strategies.

Regulatory Affairs, Quality Assurance, Regulatory Compliance, Clinical and GxP professionals in pharmaceutical, biotechnology and medical device companies benefit most, as do consultants and CRO staff supporting EU filings. Newer team members use it to build foundations, while experienced professionals use it to keep pace with changing requirements.

Choose a course based on your role, your product type and the markets you work in. Regulatory Affairs professionals typically need submission and lifecycle management training, Quality professionals need GMP and quality-system content, and medical device professionals need EU MDR/IVDR courses. If you are new to the field, start with a foundations course here, using our search function.

EU MDR (Regulation (EU) 2017/745) governs medical devices, while IVDR (Regulation (EU) 2017/746) governs in vitro diagnostic devices such as tests and reagents. MDR uses Classes I, IIa, IIb and III, while IVDR uses Classes A to D. Both require notified body involvement for most devices, technical documentation and post-market surveillance. Transition deadlines for legacy devices have been extended to 2027-2029, depending on device class.

MDR (Regulation (EU) 2023/607): 31 December 2027 for Class III and implantable Class IIb devices, and 31 December 2028 for other legacy devices (including Class IIa and other Class IIb).
IVDR (Regulation (EU) 2024/1860): 31 December 2027 for Class D, 31 December 2028 for Class C, and 31 December 2029 for Class B and sterile Class A.

The main difference is structure. In the US, the FDA is a single agency that approves medicines (via NDA/BLA) and many devices (via 510(k), De Novo or PMA). In the EU, medicines are authorised through EMA and the European Commission or through national authorities, and devices receive CE marking via notified bodies. Dossier formats, timelines and post-market obligations also differ.

An MAA is the dossier submitted to obtain permission to market a medicine in the EU, prepared in CTD/eCTD format. It can go through the centralised, decentralised, mutual recognition or national route. In the centralised procedure, EMA's standard assessment takes 210 active days (excluding clock stops), followed by a European Commission decision.

The Clinical Trials Regulation (EU) No 536/2014 replaced the Clinical Trials Directive with a harmonised submission process through the Clinical Trials Information System (CTIS). Since 31 January 2025, all clinical trials in the EU, including those that started under the old Directive, must operate under the Regulation and be managed in CTIS.

Most courses include the webinar recording, presentation PDF, and an assessment. Depending on the program, additional handouts, templates, tools, or other resources may also be provided. For Live trainings, access details and content provided is mentioned on the Live course page.

TalkFDA offers both scheduled live programs and recorded courses. Live programs are delivered on specific dates and have their own registration details, while recorded courses can be accessed according to the availability and access terms shown on the individual course page.

Yes, where a recorded version is available. TalkFDA makes selected live programs available as recorded courses after the live session. The individual course page will indicate the available learning format and what is included with access.

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TalkFDA is a professional learning platform delivering webinars, courses, enterprise onsite training labs, conferences, and community learning for life sciences organizations across pharmaceuticals, medical devices, and clinical research across the globe.

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Featured EU & Global Regulatory Training Courses