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Selling into Europe as a contract manufacturer (CDMO / CMO) from the United States
Ensure your European sales team closes deals without compliance surprises.
The moment it goes wrong
A promising European client suddenly goes silent after asking about an EU Good Manufacturing Practice (GMP) audit. Your sales team didn't know the specific requirements for an EU Qualified Person release. A signed contract might be delayed or lost, costing hundreds of thousands in potential revenue and market entry.
What changes after this course
After this course, your team will confidently discuss EU regulatory expectations with prospective clients. They will understand the Qualified Person's role and the nuances of EU GMP inspections. You will hold a training record for your sales force, demonstrating your commitment to European market readiness.
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 Landscape
- Grasp the primary regulatory bodies like the European Medicines Agency (EMA) and national competent authorities.
- Identify key EU pharmaceutical legislation, including Directive 2001/83/EC and Regulation (EU) 2017/745.
- Learn how the centralized, decentralized, and mutual recognition procedures impact market access.
2Differentiate US FDA from EU GMP Requirements
- Compare the fundamental principles of US Current Good Manufacturing Practices (cGMP) with EU GMP Annexes.
- Understand the specific differences in quality system documentation and change control expectations.
- Recognize the cost implications of non-compliance with EU GMP during an inspection.
3Prepare for EU Good Manufacturing Practice Inspections
- Learn the typical scope and duration of an EU GMP inspection by a European competent authority.
- Identify common audit findings for US manufacturers and how to proactively address them.
- Understand the process for responding to audit observations and potential follow-up actions.
4Explain the Qualified Person's Role and Release
- Define the legal responsibilities of a Qualified Person (QP) in the European Union.
- Describe the batch release process by a QP for medicinal products manufactured outside the EU.
- Understand the necessary documentation and data required for a QP to certify a batch.
5Master European Contractual Agreements
- Identify critical clauses in a Technical Agreement (Quality Agreement) for EU clients.
- Understand the liabilities and responsibilities outlined in a typical CDMO contract for Europe.
- Learn how to negotiate terms related to intellectual property and data exclusivity in Europe.
6Address Data Integrity and Electronic Records
- Explain EU expectations for data integrity, aligning with Annex 11 and relevant guidelines.
- Understand the requirements for electronic batch records and audit trails in EU GMP.
- Recognize the potential costs of data integrity failures during an EU inspection.
7Manage Quality Systems for European Clients
- Adapt your Quality Management System (QMS) to meet specific EU regulatory nuances.
- Implement effective supplier qualification procedures for European material providers.
- Understand the process for handling deviations and Out-of-Specification (OOS) results for EU batches.
8Understand Importation and Distribution into Europe
- Identify the role of the Marketing Authorization Holder (MAH) and importer of record in Europe.
- Explain the specific requirements for importing medicinal products into the European Union.
- Understand the cold chain logistics and temperature monitoring expectations for European distribution.
9Handle Post-Market Surveillance and Pharmacovigilance
- Outline the pharmacovigilance responsibilities of a CDMO supporting European products.
- Understand the reporting requirements for adverse events and product quality complaints in Europe.
- Learn about the importance of a well-defined pharmacovigilance system master file.
10Price Your Services Competitively in Europe
- Understand the cost drivers specific to European regulatory compliance and quality assurance.
- Develop pricing strategies that account for currency fluctuations and local market conditions.
- Identify how to communicate the value of your compliance efforts to potential European clients.
11Build Effective Sales and Marketing Strategies for Europe
- Tailor your sales pitch to highlight your EU GMP readiness and Qualified Person support.
- Identify key industry events and platforms for connecting with European pharmaceutical companies.
- Understand cultural nuances in business negotiations across different European countries.
12Grow Your European CDMO Business
- Develop a strategic roadmap for expanding your CDMO services within the European market.
- Identify potential partnerships or acquisitions that could accelerate your European presence.
- Measure key performance indicators (KPIs) to track your success in the European market.
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: Contract manufacturer (CDMO / CMO),
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