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Regulatory affairs by region: 31 audio courses for your whole company
Regulatory affairs by region is one of the topics Pharma Lectures covers in depth: 31 audio courses, each sold as one licence that covers every employee of the legal entity for twelve months. Every course exists in three lengths, so a board member hears the briefing, a regulatory officer takes the standard run and the people at the bench get the expanded walk-through, and every length ends with the same recorded questionnaire. Each course below ships with a companion workbook, a full transcript, a source for every fact, a certificate per learner and the auditable training record an inspector asks for. Prices start at €1,950 for the whole company and a free sample module is available for every title.
The 31 courses, with the price for your company size
Prices are for the whole company, 12 months. Pick your company size once; the site remembers it.
- European Union: eCTD that passes validation first time, module by module15 modules · 2 h 30 min to 12 h 30 min · RA, QA, BD · free sample module €5,850€9,360€14,625
- European Union: ASMF or CEP, the two roads into Europe for an API, and how to pick yours12 modules · 2 h to 10 h · RA, QA, BD · free sample module €4,680€7,488€11,700
- European Union: Variations, renewals and lifecycle without drowning in Type IBs10 modules · 1 h 40 min to 8 h 20 min · RA, QA, BD · free sample module €3,900€6,240€9,750
- European Union: Article 46b, written confirmations and GMP certificates for third-country API8 modules · 1 h 20 min to 6 h 40 min · RA, QA, BD · free sample module €3,120€4,992€7,800
- European Union: Importer licence, QP release and the arrival testing nobody budgets for10 modules · 1 h 40 min to 8 h 20 min · RA, QA, BD · free sample module €3,900€6,240€9,750
- European Union: Biosimilars at the EMA, comparability, extrapolation and the pathway12 modules · 2 h to 10 h · RA, QA, BD · free sample module €4,680€7,488€11,700
- European Union: Paediatric, orphan and hybrid applications a generic company actually meets6 modules · 1 h to 5 h · RA, QA, BD · free sample module €2,340€3,744€5,850
- European Union: The pharma legislation reform and what actually changes for an exporter5 modules · 50 min to 4 h 10 min · RA, QA, BD · free sample module €1,950€3,120€4,875
- European Union: Novel excipients and the 2015 risk-assessment guideline, decoded6 modules · 1 h to 5 h · RA, QA, BD · free sample module €2,340€3,744€5,850
- European Union: Clinical trials under CTIS and Regulation 536/2014 for CRO and sponsor staff10 modules · 1 h 40 min to 8 h 20 min · RA, QA, BD · free sample module €3,900€6,240€9,750
- European Union: UK after Brexit, MHRA licensing, Windsor Framework, UK Responsible Person8 modules · 1 h 20 min to 6 h 40 min · RA, QA, BD · free sample module €3,120€4,992€7,800
- European Union: Swissmedic, and where Switzerland quietly differs from the EU5 modules · 50 min to 4 h 10 min · RA, QA, BD · free sample module €1,950€3,120€4,875
- United States: ANDA from A to Z, filing a generic without the refuse-to-receive letter15 modules · 2 h 30 min to 12 h 30 min · RA, QA, BD · free sample module €5,850€9,360€14,625
- United States: Type II Drug Master Files and GDUFA fees, what you file, pay and get10 modules · 1 h 40 min to 8 h 20 min · RA, QA, BD · free sample module €3,900€6,240€9,750
- United States: Form 483, warning letter, import alert, how the FDA inspects a foreign site10 modules · 1 h 40 min to 8 h 20 min · RA, QA, BD · free sample module €3,900€6,240€9,750
- United States: 21 CFR 210 and 211 versus EU GMP, the differences that catch exporters8 modules · 1 h 20 min to 6 h 40 min · RA, QA, BD · free sample module €3,120€4,992€7,800
- United States: 505(b)(2) and NDA basics for the generic that is not quite a generic8 modules · 1 h 20 min to 6 h 40 min · RA, QA, BD · free sample module €3,120€4,992€7,800
- United States: DSCSA supply-chain security for exporters and distributors6 modules · 1 h to 5 h · RA, QA, BD · free sample module €2,340€3,744€5,850
- United States: Who really buys generics in America, pricing, GPOs and the channel10 modules · 1 h 40 min to 8 h 20 min · RA, QA, BD · free sample module €3,900€6,240€9,750
- Latin America: Brazil ANVISA, registration, foreign-site GMP and surviving the inspection queue12 modules · 2 h to 10 h · RA, QA, BD · free sample module €4,680€7,488€11,700
- Latin America: Mexico COFEPRIS, registration, third-party pre-review and the health licence10 modules · 1 h 40 min to 8 h 20 min · RA, QA, BD · free sample module €3,900€6,240€9,750
- Latin America: INVIMA, DIGEMID, ISP and ANMAT on one page12 modules · 2 h to 10 h · RA, QA, BD · free sample module €4,680€7,488€11,700
- Latin America: Winning hospital tenders and public health buyers8 modules · 1 h 20 min to 6 h 40 min · RA, QA, BD · free sample module €3,120€4,992€7,800
- Middle East and Africa: Saudi SFDA and the Gulf route, one file, several ministries10 modules · 1 h 40 min to 8 h 20 min · RA, QA, BD · free sample module €3,900€6,240€9,750
- Middle East and Africa: Egypt EDA, Algeria and Morocco without the detours8 modules · 1 h 20 min to 6 h 40 min · RA, QA, BD · free sample module €3,120€4,992€7,800
- Middle East and Africa: South Africa SAHPRA and the African Medicines Agency, real and planned8 modules · 1 h 20 min to 6 h 40 min · RA, QA, BD · free sample module €3,120€4,992€7,800
- Middle East and Africa: WHO prequalification, the doors it opens and the work it takes10 modules · 1 h 40 min to 8 h 20 min · RA, QA, BD · free sample module €3,900€6,240€9,750
- Asia Pacific: China NMPA for foreign companies, registration, DMF and the 2019 reform12 modules · 2 h to 10 h · RA, QA, BD · free sample module €4,680€7,488€11,700
- Asia Pacific: Japan PMDA and foreign-manufacturer accreditation, the paperwork behind it10 modules · 1 h 40 min to 8 h 20 min · RA, QA, BD · free sample module €3,900€6,240€9,750
- Asia Pacific: ASEAN and Australia TGA, harmonised CTD and GMP clearance8 modules · 1 h 20 min to 6 h 40 min · RA, QA, BD · free sample module €3,120€4,992€7,800
- Asia Pacific: Korea MFDS registration and GMP for foreign sites8 modules · 1 h 20 min to 6 h 40 min · RA, QA, BD · free sample module €3,120€4,992€7,800
How a Pharma Lectures course works
Every title is one licence for the whole legal entity, twelve months, every employee. Each module exists in three lengths: 10, 25 or 50 minutes, by role. Each module ends with a recorded multiple-choice questionnaire, so the training record is complete for the auditor. Delivered within 72 hours of payment.
- 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.
Other topics
- Pharma industry foundations25
- GMP, GDP, quality and compliance24
- Pharma export and key account management16
- Pharma sales skills and selling across cultures159
- Pharma training by country80
- Pharma training by line of business60
- Pharma training by role48
- Country and business playbooks120
- Custom in-company pharma courses5
All topics, countries, lines of business and roles
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