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Talking to a Qualified Person, a Responsible Person and a pharmacovigilance lead: what each one owns
Understand who to speak with to prevent a rejected batch or a failed audit.
The moment it goes wrong
You call the Qualified Person (QP) about a product change, but they direct you to the Responsible Person. Weeks are lost identifying the correct contact, delaying critical decisions. This misstep can lead to manufacturing hold-ups, potential stock-outs, and significant revenue loss.
What changes after this course
Your team will confidently identify the correct specialist for any product, quality, or safety query. They will know precisely what information each person needs to make informed decisions quickly. You will receive a full training record and completion certificates for your team.
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 | 50 min |
| Regulatory affairs | Standard | 2 h 05 min |
What is in the course, module by module
5 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.
1Identify the core responsibilities of key pharmaceutical roles.
- Understand the overarching principles of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
- Learn how EudraLex Volume 4, Annex 16 defines the Qualified Person's (QP) release responsibilities.
- Recognize the legal basis for the Responsible Person (RP) role under Article 17 of Directive 2001/83/EC.
2Know when and how to engage with the Qualified Person.
- Explain the QP's critical role in batch release and certification for medicinal products.
- Identify the specific documentation, such as the batch record, the QP reviews before product release.
- Understand the costly implications of releasing a non-compliant batch and the QP's liability.
3Understand the Responsible Person's domain in product distribution.
- Describe the RP's duties in maintaining the quality system for wholesale distribution activities.
- Identify key documents like the quality agreement and self-inspection reports relevant to the RP.
- Recognize the serious consequences of a supply chain breach and the RP's responsibility for recall decisions.
4Communicate effectively with the pharmacovigilance lead on safety issues.
- Grasp the pharmacovigilance lead's mandate for monitoring the safety of medicinal products.
- Understand the importance of the Pharmacovigilance System Master File (PSMF) and its contents.
- Explain the significant regulatory penalties for failing to report adverse drug reactions promptly.
5Master communication strategies for product quality and safety concerns.
- Differentiate between issues requiring QP, RP, or pharmacovigilance lead input.
- Learn the correct internal escalation procedures for urgent quality or safety events.
- Understand how misdirected communication can delay critical decisions and impact patient safety.
Price for this title
One licence, 5 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: Business development and export sales, Regulatory affairs,
Businesses: every kind of pharma company
Countries: India China Türkiye Korea Japan Taiwan Egypt, Gulf and MENA Brazil and Latin America Pakistan, Bangladesh and Vietnam United States Europe
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