Courses › Nationality and niche combinations
Selling into Europe as an API and intermediates maker from the United States
Avoid a stalled shipment and protect your European market entry with this training.
The moment it goes wrong
Your first API shipment to Europe is detained at customs due to incorrect documentation. This leads to costly delays, storage fees, and potential penalties. Your European customer's production schedule is disrupted, damaging your new business relationship.
What changes after this course
Your sales and regulatory teams will confidently prepare for European API market entry. They will understand the specific quality and import requirements for each country. You will receive a training record and certificates for all participants, ready for audit.
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 EU Regulatory Structure for API Imports
- Identify the roles of the European Medicines Agency and national competent authorities.
- Learn how the European Union's pharmaceutical legislation applies to active pharmaceutical ingredients.
- Recognize the cost of non-compliance, including potential market exclusion.
2Comply with EU Good Manufacturing Practice for APIs
- Grasp the core principles of EU GMP Part II for active pharmaceutical ingredients.
- Understand how EudraLex Volume 4, Part II, dictates manufacturing and quality control.
- Avoid common GMP deficiencies that lead to audit failures and product rejection.
3Prepare Your Site for EU GMP Inspections
- Identify key documents and records required for an EU GMP inspection.
- Learn how to present your Quality Management System to European inspectors.
- Understand the cost of a failed inspection, including potential import bans.
4Master the API Import Authorization Process
- Understand the requirement for written confirmation for imported active pharmaceutical ingredients.
- Learn the process for obtaining a written confirmation from a national competent authority.
- Recognize the specific data points needed for a complete import authorization application.
5Develop Your Qualified Person Declaration Strategy
- Understand the critical role of the Qualified Person in the European supply chain.
- Learn what information a Qualified Person needs to declare imported active pharmaceutical ingredients.
- Identify potential errors in Qualified Person declarations that cause shipment delays.
6Manage Your Supply Chain for EU Compliance
- Establish clear responsibilities across your supply chain partners for EU compliance.
- Understand the importance of supplier qualification specific to European regulations.
- Recognize the cost of an unqualified supplier, including product recalls.
7Understand EU Customs and Import Procedures
- Identify the necessary customs declarations and documents for API shipments into the EU.
- Learn about Incoterms and their impact on responsibilities and costs for international trade.
- Avoid common customs clearance mistakes that lead to costly border delays.
8Address Quality Defects and Recalls in Europe
- Understand your responsibilities for reporting quality defects to European authorities.
- Learn the procedures for initiating and managing an API recall within the European Union.
- Recognize the financial and reputational cost of mishandling a quality defect incident.
9Comply with REACH and Other Chemical Regulations
- Understand if your API or intermediate requires registration under the REACH regulation.
- Learn how to determine your obligations under the European Chemicals Agency framework.
- Identify the penalties for non-compliance with chemical registration requirements.
10Prepare for Post-Market Surveillance and Vigilance
- Understand your ongoing obligations for monitoring API quality once in the EU market.
- Learn how to respond to adverse event reports or quality complaints from European customers.
- Recognize the importance of timely reporting to maintain market authorization.
11Implement a European Pharmacovigilance System
- Understand the basic requirements for pharmacovigilance as an API supplier.
- Learn how to interface with your European customers' pharmacovigilance systems.
- Identify the specific reporting timelines for serious adverse events involving your API.
12Develop Your European Market Entry Strategy
- Consolidate all regulatory requirements into a comprehensive market entry checklist.
- Learn to identify and prioritize target European countries based on regulatory ease.
- Understand the importance of a phased approach to European market expansion.
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: API and intermediates maker,
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