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Selling into Europe as a pharma software and AI vendor from the United States
Secure your European market entry and avoid costly compliance missteps.
The moment it goes wrong
Your sales team just lost a major European deal because they couldn't answer questions about GDPR compliance. This oversight delayed your market entry by months, costing millions in potential revenue. A single data privacy violation fine could reach up to 4% of your annual global turnover.
What changes after this course
After this course, your team will confidently discuss EU regulations and data protection with European clients. They will understand the necessary documentation for market entry and local sales. You will have a verifiable training record for your staff, demonstrating their readiness for the European market.
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 diverse European pharmaceutical market structure.
- Recognize the key differences between the European Medicines Agency and national competent authorities.
- Identify the major pharmaceutical hubs and their regulatory nuances across Europe.
- Comprehend the market access challenges unique to different European countries.
2Grasp core EU regulations impacting pharma software and AI.
- Explain the scope and impact of the Medical Device Regulation (MDR) on health software.
- Summarize the General Data Protection Regulation (GDPR) requirements for patient data processing.
- Differentiate between software as a medical device (SaMD) and general IT software classifications.
3Implement strong data privacy practices compliant with GDPR.
- Identify the seven key principles of GDPR and their application to software solutions.
- Outline the requirements for Data Protection Impact Assessments (DPIAs) in Europe.
- Understand the legal basis for processing sensitive health data under Article 9 of GDPR.
4Classify and ensure compliance for Software as a Medical Device.
- Determine if your software qualifies as a medical device under the EU MDR.
- Explain the classification rules for SaMD according to Annex VIII of the MDR.
- Recognize the critical role of a Quality Management System (QMS) for SaMD compliance.
5Achieve CE Marking for your pharmaceutical software products.
- Describe the steps involved in the CE marking process for medical device software.
- Identify the role of Notified Bodies in conformity assessment for higher-risk devices.
- Understand the essential requirements checklist found in Annex I of the MDR.
6Build a QMS that meets EU regulatory expectations for software.
- Explain how ISO 13485 standards align with EU MDR requirements for medical devices.
- Identify the necessary documentation for a compliant Quality Management System, including design controls.
- Prevent common QMS audit findings that delay market entry and product launch.
7Address cybersecurity requirements for EU pharmaceutical software.
- Understand the cybersecurity expectations outlined in the EU MDR for medical devices.
- Identify common vulnerabilities in software and AI systems that require mitigation.
- Recognize the importance of a post-market surveillance plan for cybersecurity threats.
8Develop effective market entry strategies for European countries.
- Decide on the appropriate legal entity structure for selling in different EU member states.
- Understand the implications of appointing an EU Authorized Representative for your products.
- Identify the critical legal and tax considerations for establishing a presence in Europe.
9Structure sales agreements and contracts for European clients.
- Recognize key differences in European contract law compared to United States law.
- Understand the importance of data processing agreements (DPAs) with clients.
- Identify common pitfalls in service level agreements (SLAs) with European pharma companies.
10Manage post-market surveillance and vigilance for EU software sales.
- Explain the requirements for post-market surveillance (PMS) under the EU MDR.
- Understand the reporting obligations for serious incidents and field safety corrective actions.
- Identify the European database for medical devices, EUDAMED, and its role in vigilance.
11Prepare for and succeed in European regulatory audits and inspections.
- Identify the common focus areas of Notified Body audits for medical device software.
- Understand the typical audit process and required documentation for an inspection.
- Prevent major non-conformities that can lead to product recalls or market withdrawal.
12Build a compliant sales and support team for European operations.
- Develop training programs for your European sales team on regulatory compliance.
- Understand the need for local language support and cultural sensitivity in sales.
- Identify the resources required for ongoing regulatory intelligence and updates.
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: Pharma software and AI vendor,
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