Courses › Sales skills, selling across cultures, and the objections per market
Objections Europeans raise against a supplier from Taiwan, and the answer to each one
Your European deals depend on convincing them your quality systems are sound.
The moment it goes wrong
A European client's Qualified Person might reject a batch due to unclear documentation, leading to significant delays and financial losses. An inspection finding could halt future imports, causing contract termination and damaging your company's reputation. This directly impacts your revenue targets and market share.
What changes after this course
Your sales team will confidently articulate your compliance with EU regulations and address specific quality concerns. They will know what documents to present and how to discuss your processes. You will receive a training record and certificates for each participant, demonstrating their enhanced understanding.
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 |
|---|---|---|
| Business development and export sales | Briefing | 1 h |
| Owner, CEO and board | Briefing | 1 h |
What is in the course, module by module
6 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.
1Explain the EU pharmaceutical regulatory framework to your customers.
- Describe the role of the European Medicines Agency and national competent authorities.
- Identify key EU Good Manufacturing Practice guidelines relevant to third-country suppliers.
- Outline the importance of EudraLex Volume 4 and its specific annexes for compliance.
2Justify your Quality Management System to European auditors.
- Detail how your Quality Management System aligns with ICH Q10 Pharmaceutical Quality System.
- Explain your change control procedures and their alignment with EU GMP expectations.
- Present your CAPA (Corrective and Preventive Actions) process as per EU regulatory requirements.
3Prepare for and confidently manage European regulatory inspections.
- Identify common audit findings for non-EU suppliers during European inspections.
- Explain the typical stages of an EU GMP inspection and how to prepare for each.
- Describe the process for responding to inspection observations and closing out deficiencies.
4Prove your data integrity and documentation meet European expectations.
- Explain the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) for data integrity.
- Discuss the specific documentation required for batch release by a Qualified Person in Europe.
- Detail the record-keeping standards for manufacturing and quality control data.
5Address European concerns about your supply chain and product distribution.
- Explain how your supply chain ensures product quality and prevents counterfeiting.
- Describe compliance with Good Distribution Practice (GDP) guidelines for product transit to Europe.
- Detail the process for managing product recalls and market withdrawals in the European Union.
6Build lasting trust and communication with your European partners.
- Describe effective communication strategies for addressing European customer concerns proactively.
- Explain the importance of cultural awareness in European business negotiations.
- Identify key performance indicators for maintaining successful long-term supplier relationships.
Price for this title
One licence, 6 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,
Businesses: every kind of pharma company
Countries: Taiwan
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