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Selling into Europe as a regulatory and QA consultancy from the United States
You need to close the European deal without regulatory surprises.
The moment it goes wrong
Your team overlooks a crucial EudraLex Annex requirement, leading to an unexpected audit failure. The resulting product recall and remediation efforts cost your client millions and damage your consultancy's reputation.
What changes after this course
Your team will confidently guide clients through European regulatory submissions and quality system requirements. You will have a verifiable training record, ensuring your staff are prepared for European market challenges.
How long it takes, by who is listening
Nobody spends a day in a classroom. Every module exists in three lengths; a person takes the length their role needs, and every length ends with the same recorded questionnaire, so the training record is complete either way.
| Who takes this course | Length | Total time |
|---|---|---|
| Owner, CEO and board | Briefing | 2 h |
| Business development and export sales | Briefing | 2 h |
| Regulatory affairs | Standard | 5 h |
| Quality assurance and Qualified Person | Standard | 5 h |
What is in the course, module by module
12 modules. Under each title are the three things the listener can do afterwards; the audio itself runs 10 to 50 minutes depending on the length chosen. Each module ends with a multiple-choice questionnaire whose result is recorded per person for your auditor. Your human-resources or quality manager decides what counts as passed and when a level is retaken.
1Understand the European Regulatory Framework
- The European Union regulatory system differs significantly from the United States Food and Drug Administration.
- Key European institutions include the European Medicines Agency and national Competent Authorities.
- Misinterpreting the scope of EudraLex Volume 4 can lead to costly non-compliance.
2Master CE Marking for Medical Devices
- The CE mark signifies compliance with EU health, safety, and environmental protection standards.
- Understand the requirements of the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
- Failing to secure a Notified Body assessment can delay market entry by over a year.
3Navigate Notified Body Selection and Interaction
- Notified Bodies are independent organizations designated to assess conformity against EU regulations.
- Select a Notified Body based on product scope, accreditation, and availability for your client.
- Choosing an inexperienced Notified Body can result in prolonged certification timelines.
4Implement Good Manufacturing Practice (GMP) for Europe
- European Union Good Manufacturing Practice is detailed in EudraLex Volume 4.
- Understand the specific requirements for Qualified Persons and batch release in the EU.
- A single deviation from Annex 1 requirements for sterile products can lead to a facility shutdown.
5Apply Good Distribution Practice (GDP) Across Europe
- European Good Distribution Practice guidelines ensure quality and integrity of medicines during distribution.
- Key documents include the EU GDP Guidelines 2013/C 343/01 for medicinal products.
- Inadequate temperature mapping of storage facilities risks product degradation and batch destruction.
6Comply with EU Pharmacovigilance Requirements
- The European Union has specific pharmacovigilance obligations to monitor drug safety.
- Understand the role of the Qualified Person for Pharmacovigilance (QPPV) and EudraVigilance.
- Late reporting of an adverse drug reaction can result in significant regulatory fines.
7Address EU Clinical Trial Regulations
- The Clinical Trials Regulation (EU) No 536/2014 harmonizes clinical trial procedures across the EU.
- Understand the Clinical Trials Information System (CTIS) for submitting and assessing trial applications.
- A poorly drafted patient information sheet can halt trial approval for months.
8Manage Post-Market Surveillance in the EU
- Post-market surveillance is mandatory for medical devices and in vitro diagnostics under MDR and IVDR.
- Develop a Post-Market Surveillance Plan (PMS Plan) and Periodic Safety Update Report (PSUR).
- Ignoring emerging safety signals can lead to product recalls and market withdrawal.
9Handle EU Regulatory Audits and Inspections
- Prepare for audits by national Competent Authorities and Notified Bodies.
- Understand common audit findings and how to respond to inspection observations.
- An unprepared team during an inspection can lead to critical findings and market access delays.
10Master EU Labeling and Packaging Requirements
- Specific labeling requirements for medicinal products are found in Directive 2001/83/EC and related guidance.
- Understand language requirements and the use of the EAN (European Article Number) for product identification.
- Incorrect labeling information can lead to batch rejections at customs and significant re-work costs.
11Understand Data Protection and Cybersecurity in the EU
- The General Data Protection Regulation (GDPR) governs personal data processing in the EU.
- Understand data transfer mechanisms and the role of Data Protection Officers in pharmaceutical operations.
- A data breach involving patient information can incur fines up to 4% of global annual turnover.
12Develop a European Market Entry Strategy
- Integrate regulatory and quality considerations into a comprehensive market entry plan.
- Map out timelines for regulatory submissions, Notified Body engagement, and local registrations.
- Underestimating the time for regulatory approval can cause significant budget overruns and missed revenue targets.
Price for this title
One licence, 12 modules in all three lengths, included in every purchase, every employee of the legal entity, 12 months. Pick your company size.
Cheaper as part of a track pack or company library. Delivered within 72 hours of payment or the course is free.
Custom course or custom pricing? A course built on your own procedures and products, a mixed bundle, several legal entities, or a budget that does not fit a table: tell us on WhatsApp and you have a written quote the same day.
Ask about custom courses and custom pricingWho this is for
Roles: Owner, CEO and board, Business development and export sales, Regulatory affairs, Quality assurance and Qualified Person,
Businesses: Regulatory and QA consultancy,
Countries: United States
What you receive
- Audio modules in all three lengths, included in every purchase. The briefing for the board and the sales floor, the standard run for regulatory and quality, the expanded walk-through for the bench. One price buys all three; each person takes the length their role needs. Listen on the commute, at the bench, in the car.
- Made to be listened to. A narrator with character, a story in every module and real examples from the buyer's side of the table. Not a read-out of the guideline that puts the room to sleep.
- Companion workbook. Exercises and checklists per module, ready to file.
- Full transcript. Searchable, printable, quotable in your procedures.
- Source for every fact. Each statement links to its guideline, regulation or paper, so an auditor can check it.
- Certificate per learner. Name, course, hours, guideline version, date.
- Auditable training record. Per-person export for your quality file, the document inspectors ask for under EU GMP Chapter 2.
English first. Other languages are available in test mode on request.
Request a free sample module