In-company pharma courses, for every role in the building
Your people lose European deals in the one minute they cannot answer a buyer's question. Close that minute.
Hundreds of courses for sales, quality, regulatory, production, supply chain, finance and new hires. One-hour audio modules with a companion workbook, a full transcript, a source for every fact, a certificate per learner and the auditable training record your inspector asks for.
Hundreds of titles. Priced per module for the whole company, not per seat. Delivered within 72 hours of payment or your money back.
Produced by a professorQuantitative finance, Carnegie Mellon University
Owned by an EU wholesalerUAB Clusi Pharma, licensed in Lithuania. We sell into Europe ourselves.
Every fact sourcedEach statement links to its guideline, regulation or paper
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How medicines reach a European patient: the whole chain from API to pharmacy All staff, new hires The European Union for pharma people: EMA, national agencies, EDQM, the Commission, who decides what All staff Centralised, decentralised, mutual recognition and national procedures explained RA, BD, management The marketing authorisation holder: what the MAH must do every year RA, QA, management Good Manufacturing Practice from zero: EudraLex Volume 4 read chapter by chapter All technical staff Good Distribution Practice from zero: the 2013 EU guideline read article by article Traders, logistics, QA The Qualified Person: why one signature controls every batch sold in Europe Management, QA, BD The Responsible Person for distribution: duties, liability, how to work with one Traders, wholesalers EU inspections: how an EMA or national GMP inspection runs, day by day QA, production, management Falsified Medicines Directive and serialisation: what every box must carry Packaging, supply chain, IT Pharmacovigilance for non-specialists: what a QPPV does and why your company needs one Management, BD, PV Medical devices and combination products: when a product falls under MDR instead RA, BD European pharmaceutical pricing and reimbursement: how a price is set in each big market BD, finance, management Hospital tenders in Europe: how public procurement of medicines works BD, finance Named-patient and unlicensed supply: the legal routes to sell without an authorisation BD, RA, traders The European generic market by country: Germany, France, Italy, Spain, Poland, Nordics, Baltics, Balkans BD, management European contract law for supply, quality and distribution agreements BD, legal, management The Quality Agreement and the Technical Agreement: every clause explained QA, BD, CDMO staff Data integrity: ALCOA+, audit trails and what inspectors look for QC, QA, IT, production Annex 1 sterile manufacturing 2022: what changed and what inspectors now ask Production, QA, engineering Nitrosamines: risk assessment, testing and reporting in the EU QC, RA, API staff Environmental and social reporting for pharma suppliers: CSRD, EcoVadis, PSCI audits Management, QA, sales The EU AI Act and computerised systems: Annex 11 and GAMP 5 for pharma IT, QA, validation Pharma English: writing deviations, CAPAs, emails and reports a European reader trusts All staff Business English for pharma sales: calls, meetings, trade-show conversations, negotiations BD, sales, marketing European Union: CTD and eCTD for the EU: building a dossier that passes validation RA, QA, BD European Union: Active Substance Master File and Certificate of Suitability (CEP): the two roads into Europe for an API RA, QA, BD European Union: Variations, renewals and lifecycle management in the EU RA, QA, BD European Union: GMP certificates, written confirmations and the Article 46b rules for third-country API RA, QA, BD European Union: Importation into the EU: the importer licence, QP release and batch testing on arrival RA, QA, BD European Union: Biosimilars in the EU: comparability, extrapolation and the EMA pathway RA, QA, BD European Union: Paediatric, orphan and hybrid applications: when they apply to a generic company RA, QA, BD European Union: The EU pharmaceutical legislation reform: what changes for exporters RA, QA, BD European Union: EU excipient rules: novel excipients, risk assessment under the 2015 guideline RA, QA, BD European Union: Clinical trials in the EU: CTIS and Regulation 536/2014 for CRO and sponsor staff RA, QA, BD European Union: UK after Brexit: MHRA licensing, Windsor Framework, UK Responsible Person RA, QA, BD European Union: Switzerland: Swissmedic and how it differs from the EU RA, QA, BD United States: ANDA from A to Z: filing a generic with the FDA RA, QA, BD United States: Type II Drug Master Files and the GDUFA fee system RA, QA, BD United States: FDA inspections of foreign sites: Form 483, warning letters, import alerts RA, QA, BD United States: 21 CFR 210 and 211 versus EU GMP: the differences that catch exporters RA, QA, BD United States: 505(b)(2) and NDA basics for differentiated generics RA, QA, BD United States: US supply-chain security act (DSCSA) for exporters and distributors RA, QA, BD United States: US pricing, group purchasing organisations and the generic distribution channel RA, QA, BD Latin America: Brazil ANVISA: registration, GMP certification of foreign sites and the inspection queue RA, QA, BD Latin America: Mexico COFEPRIS: registration, third-party pre-review and the health licence RA, QA, BD Latin America: Colombia INVIMA, Peru DIGEMID, Chile ISP, Argentina ANMAT: a working comparison RA, QA, BD Latin America: Selling to Latin American hospital tenders and public health buyers RA, QA, BD Middle East and Africa: Saudi SFDA and the Gulf registration route RA, QA, BD Middle East and Africa: Egypt EDA, Algeria, Morocco: North African registration RA, QA, BD Middle East and Africa: South Africa SAHPRA and the African Medicines Agency RA, QA, BD Middle East and Africa: WHO prequalification: what it unlocks and how to get it RA, QA, BD Asia Pacific: China NMPA for foreign companies: registration, DMF and the 2019 reform RA, QA, BD Asia Pacific: Japan PMDA and the accreditation of foreign manufacturers RA, QA, BD Asia Pacific: ASEAN and Australia TGA: harmonised CTD and GMP clearance RA, QA, BD Asia Pacific: Korea MFDS registration and GMP for foreign sites RA, QA, BD Pharmaceutical Quality System (ICH Q10) built from scratch for a small or mid-sized company QA, management Deviations, CAPA and root cause analysis that satisfy a European inspector QA, production Change control and risk management (ICH Q9) in daily practice QA, production Supplier qualification and auditing: how Europeans will audit you and how you audit others QA, purchasing Process validation, cleaning validation and continued process verification Production, QA, engineering Analytical method validation and transfer (ICH Q2 R2 and Q14) QC Stability studies for the EU and ICH zones: design, storage, reporting QC, RA Out-of-specification and out-of-trend results: the investigation an inspector expects QC, QA Computerised system validation and the move to cloud systems IT, QA Pharmaceutical microbiology and environmental monitoring QC, production Elemental impurities (ICH Q3D) and residual solvents for API and finished dose QC, RA Good documentation practice and batch record review All technical staff Qualification of equipment, utilities and facilities (URS to PQ) Engineering, QA Handling a European customer audit: the two days, the report, the response QA, management, sales Handling an EU or FDA inspection remotely and on site: roles, back room, answers QA, management Writing SOPs that people follow and inspectors accept QA, all technical staff Temperature-controlled storage and transport: mapping, excursions, qualification Logistics, QA Returns, recalls, complaints and falsified product handling QA, logistics, sales Contamination control strategy under the new Annex 1 Production, QA Continuous manufacturing and ICH Q13 for companies planning the step Engineering, management GMP for excipients and the IPEC and EXCiPACT schemes Excipient suppliers GMP for API: ICH Q7 chapter by chapter API staff GMP for biologics: Part II Annex 2 and the differences from small molecules Biologics staff GMP for investigational products and clinical supply CRO, CDMO How a European buyer chooses a supplier: the real scorecard, from audit to price BD, management Finding, qualifying and approaching European customers without an agent BD Trade-show selling: before the show, at the stand, and the follow-up BD, marketing Pricing for Europe: landed cost, Incoterms, currency, margin stacking through the chain BD, finance Winning European hospital tenders: reading a call, bidding, supply guarantees, penalties BD, finance Dossier licensing and out-licensing: selling a registered dossier to a European MAH BD, RA Contract manufacturing sales: how a CDMO wins and keeps a European client CDMO BD Distribution agreements, exclusivity, territory and termination in Europe BD, legal Key account management for a long-term European customer BD, sales Export documents, customs, VAT, duty and the EU importer of record Logistics, finance, sales Payment terms, letters of credit, credit insurance and getting paid by Europeans Finance, sales Building a European subsidiary or branch: when, where, cost and licences Management Partnering with a European wholesaler or licence holder: the named-patient and early-access model BD, management Digital demand generation for pharma B2B: search, LinkedIn, email, trade directories Marketing, BD Writing a company profile, product list and capability deck Europeans take seriously Marketing, BD Reputation, shortages and the opportunity for new suppliers in Europe Management, BD Selling to Europeans when you are from India: culture, expectations and the mistakes that lose deals India companies How Europeans see suppliers from India: reputation, prejudice and how to turn it around India companies India regulatory system versus the EU: a side-by-side for RA and QA staff India companies From India GMP to EU GMP: the gap list and how to close it India companies Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from India India companies Email, calls and meetings in English for India teams: tone, directness, follow-up India companies Case studies: India companies that succeeded in Europe and what they did differently India companies First 90 days of a India export manager assigned to Europe India companies Selling to Europeans when you are from China: culture, expectations and the mistakes that lose deals China companies How Europeans see suppliers from China: reputation, prejudice and how to turn it around China companies China regulatory system versus the EU: a side-by-side for RA and QA staff China companies From China GMP to EU GMP: the gap list and how to close it China companies Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from China China companies Email, calls and meetings in English for China teams: tone, directness, follow-up China companies Case studies: China companies that succeeded in Europe and what they did differently China companies First 90 days of a China export manager assigned to Europe China companies Selling to Europeans when you are from Türkiye: culture, expectations and the mistakes that lose deals Türkiye companies How Europeans see suppliers from Türkiye: reputation, prejudice and how to turn it around Türkiye companies Türkiye regulatory system versus the EU: a side-by-side for RA and QA staff Türkiye companies From Türkiye GMP to EU GMP: the gap list and how to close it Türkiye companies Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Türkiye Türkiye companies Email, calls and meetings in English for Türkiye teams: tone, directness, follow-up Türkiye companies Case studies: Türkiye companies that succeeded in Europe and what they did differently Türkiye companies First 90 days of a Türkiye export manager assigned to Europe Türkiye companies Selling to Europeans when you are from Korea: culture, expectations and the mistakes that lose deals Korea companies How Europeans see suppliers from Korea: reputation, prejudice and how to turn it around Korea companies Korea regulatory system versus the EU: a side-by-side for RA and QA staff Korea companies From Korea GMP to EU GMP: the gap list and how to close it Korea companies Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Korea Korea companies Email, calls and meetings in English for Korea teams: tone, directness, follow-up Korea companies Case studies: Korea companies that succeeded in Europe and what they did differently Korea companies First 90 days of a Korea export manager assigned to Europe Korea companies Selling to Europeans when you are from Japan: culture, expectations and the mistakes that lose deals Japan companies How Europeans see suppliers from Japan: reputation, prejudice and how to turn it around Japan companies Japan regulatory system versus the EU: a side-by-side for RA and QA staff Japan companies From Japan GMP to EU GMP: the gap list and how to close it Japan companies Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Japan Japan companies Email, calls and meetings in English for Japan teams: tone, directness, follow-up Japan companies Case studies: Japan companies that succeeded in Europe and what they did differently Japan companies First 90 days of a Japan export manager assigned to Europe Japan companies Selling to Europeans when you are from Taiwan: culture, expectations and the mistakes that lose deals Taiwan companies How Europeans see suppliers from Taiwan: reputation, prejudice and how to turn it around Taiwan companies Taiwan regulatory system versus the EU: a side-by-side for RA and QA staff Taiwan companies From Taiwan GMP to EU GMP: the gap list and how to close it Taiwan companies Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Taiwan Taiwan companies Email, calls and meetings in English for Taiwan teams: tone, directness, follow-up Taiwan companies Case studies: Taiwan companies that succeeded in Europe and what they did differently Taiwan companies First 90 days of a Taiwan export manager assigned to Europe Taiwan companies Selling to Europeans when you are from Egypt, Gulf and MENA: culture, expectations and the mistakes that lose deals Egypt, Gulf and MENA companies How Europeans see suppliers from Egypt, Gulf and MENA: reputation, prejudice and how to turn it around Egypt, Gulf and MENA companies Egypt, Gulf and MENA regulatory system versus the EU: a side-by-side for RA and QA staff Egypt, Gulf and MENA companies From Egypt, Gulf and MENA GMP to EU GMP: the gap list and how to close it Egypt, Gulf and MENA companies Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Egypt, Gulf and MENA Egypt, Gulf and MENA companies Email, calls and meetings in English for Egypt, Gulf and MENA teams: tone, directness, follow-up Egypt, Gulf and MENA companies Case studies: Egypt, Gulf and MENA companies that succeeded in Europe and what they did differently Egypt, Gulf and MENA companies First 90 days of a Egypt, Gulf and MENA export manager assigned to Europe Egypt, Gulf and MENA companies Selling to Europeans when you are from Brazil and Latin America: culture, expectations and the mistakes that lose deals Brazil and Latin America companies How Europeans see suppliers from Brazil and Latin America: reputation, prejudice and how to turn it around Brazil and Latin America companies Brazil and Latin America regulatory system versus the EU: a side-by-side for RA and QA staff Brazil and Latin America companies From Brazil and Latin America GMP to EU GMP: the gap list and how to close it Brazil and Latin America companies Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Brazil and Latin America Brazil and Latin America companies Email, calls and meetings in English for Brazil and Latin America teams: tone, directness, follow-up Brazil and Latin America companies Case studies: Brazil and Latin America companies that succeeded in Europe and what they did differently Brazil and Latin America companies First 90 days of a Brazil and Latin America export manager assigned to Europe Brazil and Latin America companies Selling to Europeans when you are from Pakistan, Bangladesh and Vietnam: culture, expectations and the mistakes that lose deals Pakistan, Bangladesh and Vietnam companies How Europeans see suppliers from Pakistan, Bangladesh and Vietnam: reputation, prejudice and how to turn it around Pakistan, Bangladesh and Vietnam companies Pakistan, Bangladesh and Vietnam regulatory system versus the EU: a side-by-side for RA and QA staff Pakistan, Bangladesh and Vietnam companies From Pakistan, Bangladesh and Vietnam GMP to EU GMP: the gap list and how to close it Pakistan, Bangladesh and Vietnam companies Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam companies Email, calls and meetings in English for Pakistan, Bangladesh and Vietnam teams: tone, directness, follow-up Pakistan, Bangladesh and Vietnam companies Case studies: Pakistan, Bangladesh and Vietnam companies that succeeded in Europe and what they did differently Pakistan, Bangladesh and Vietnam companies First 90 days of a Pakistan, Bangladesh and Vietnam export manager assigned to Europe Pakistan, Bangladesh and Vietnam companies Selling to Europeans when you are from United States: culture, expectations and the mistakes that lose deals United States companies How Europeans see suppliers from United States: reputation, prejudice and how to turn it around United States companies United States regulatory system versus the EU: a side-by-side for RA and QA staff United States companies From United States GMP to EU GMP: the gap list and how to close it United States companies Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from United States United States companies Email, calls and meetings in English for United States teams: tone, directness, follow-up United States companies Case studies: United States companies that succeeded in Europe and what they did differently United States companies First 90 days of a United States export manager assigned to Europe United States companies Europe playbook for the api and intermediates maker: licences, documents, customers, timeline, cost API and intermediates maker What European customers audit at the api and intermediates maker: the checklist API and intermediates maker The regulatory file a European buyer asks the api and intermediates maker for, and how to prepare it API and intermediates maker Pricing and contracts in Europe for the api and intermediates maker API and intermediates maker Onboarding a new hire at the api and intermediates maker: company, industry and Europe in one week API and intermediates maker Europe playbook for the contract manufacturer (cdmo / cmo): licences, documents, customers, timeline, cost Contract manufacturer (CDMO / CMO) What European customers audit at the contract manufacturer (cdmo / cmo): the checklist Contract manufacturer (CDMO / CMO) The regulatory file a European buyer asks the contract manufacturer (cdmo / cmo) for, and how to prepare it Contract manufacturer (CDMO / CMO) Pricing and contracts in Europe for the contract manufacturer (cdmo / cmo) Contract manufacturer (CDMO / CMO) Onboarding a new hire at the contract manufacturer (cdmo / cmo): company, industry and Europe in one week Contract manufacturer (CDMO / CMO) Europe playbook for the finished-dose generic company: licences, documents, customers, timeline, cost Finished-dose generic company What European customers audit at the finished-dose generic company: the checklist Finished-dose generic company The regulatory file a European buyer asks the finished-dose generic company for, and how to prepare it Finished-dose generic company Pricing and contracts in Europe for the finished-dose generic company Finished-dose generic company Onboarding a new hire at the finished-dose generic company: company, industry and Europe in one week Finished-dose generic company Europe playbook for the biologics and biosimilars: licences, documents, customers, timeline, cost Biologics and biosimilars What European customers audit at the biologics and biosimilars: the checklist Biologics and biosimilars The regulatory file a European buyer asks the biologics and biosimilars for, and how to prepare it Biologics and biosimilars Pricing and contracts in Europe for the biologics and biosimilars Biologics and biosimilars Onboarding a new hire at the biologics and biosimilars: company, industry and Europe in one week Biologics and biosimilars Europe playbook for the excipient supplier: licences, documents, customers, timeline, cost Excipient supplier What European customers audit at the excipient supplier: the checklist Excipient supplier The regulatory file a European buyer asks the excipient supplier for, and how to prepare it Excipient supplier Pricing and contracts in Europe for the excipient supplier Excipient supplier Onboarding a new hire at the excipient supplier: company, industry and Europe in one week Excipient supplier Europe playbook for the packaging and machinery supplier: licences, documents, customers, timeline, cost Packaging and machinery supplier What European customers audit at the packaging and machinery supplier: the checklist Packaging and machinery supplier The regulatory file a European buyer asks the packaging and machinery supplier for, and how to prepare it Packaging and machinery supplier Pricing and contracts in Europe for the packaging and machinery supplier Packaging and machinery supplier Onboarding a new hire at the packaging and machinery supplier: company, industry and Europe in one week Packaging and machinery supplier Europe playbook for the nutraceutical and natural products: licences, documents, customers, timeline, cost Nutraceutical and natural products What European customers audit at the nutraceutical and natural products: the checklist Nutraceutical and natural products The regulatory file a European buyer asks the nutraceutical and natural products for, and how to prepare it Nutraceutical and natural products Pricing and contracts in Europe for the nutraceutical and natural products Nutraceutical and natural products Onboarding a new hire at the nutraceutical and natural products: company, industry and Europe in one week Nutraceutical and natural products Europe playbook for the trader, distributor, wholesaler: licences, documents, customers, timeline, cost Trader, distributor, wholesaler What European customers audit at the trader, distributor, wholesaler: the checklist Trader, distributor, wholesaler The regulatory file a European buyer asks the trader, distributor, wholesaler for, and how to prepare it Trader, distributor, wholesaler Pricing and contracts in Europe for the trader, distributor, wholesaler Trader, distributor, wholesaler Onboarding a new hire at the trader, distributor, wholesaler: company, industry and Europe in one week Trader, distributor, wholesaler Europe playbook for the regulatory and qa consultancy: licences, documents, customers, timeline, cost Regulatory and QA consultancy What European customers audit at the regulatory and qa consultancy: the checklist Regulatory and QA consultancy The regulatory file a European buyer asks the regulatory and qa consultancy for, and how to prepare it Regulatory and QA consultancy Pricing and contracts in Europe for the regulatory and qa consultancy Regulatory and QA consultancy Onboarding a new hire at the regulatory and qa consultancy: company, industry and Europe in one week Regulatory and QA consultancy Europe playbook for the cro and analytical laboratory: licences, documents, customers, timeline, cost CRO and analytical laboratory What European customers audit at the cro and analytical laboratory: the checklist CRO and analytical laboratory The regulatory file a European buyer asks the cro and analytical laboratory for, and how to prepare it CRO and analytical laboratory Pricing and contracts in Europe for the cro and analytical laboratory CRO and analytical laboratory Onboarding a new hire at the cro and analytical laboratory: company, industry and Europe in one week CRO and analytical laboratory Europe playbook for the pharma software and ai vendor: licences, documents, customers, timeline, cost Pharma software and AI vendor What European customers audit at the pharma software and ai vendor: the checklist Pharma software and AI vendor The regulatory file a European buyer asks the pharma software and ai vendor for, and how to prepare it Pharma software and AI vendor Pricing and contracts in Europe for the pharma software and ai vendor Pharma software and AI vendor Onboarding a new hire at the pharma software and ai vendor: company, industry and Europe in one week Pharma software and AI vendor Europe playbook for the pharma logistics and cold chain: licences, documents, customers, timeline, cost Pharma logistics and cold chain What European customers audit at the pharma logistics and cold chain: the checklist Pharma logistics and cold chain The regulatory file a European buyer asks the pharma logistics and cold chain for, and how to prepare it Pharma logistics and cold chain Pricing and contracts in Europe for the pharma logistics and cold chain Pharma logistics and cold chain Onboarding a new hire at the pharma logistics and cold chain: company, industry and Europe in one week Pharma logistics and cold chain Owner, CEO and board: the European essentials in one course Owner, CEO and board Owner, CEO and board: the first month in a pharma company, from zero Owner, CEO and board Owner, CEO and board: working with European counterparts day to day Owner, CEO and board Owner, CEO and board: the ten documents and systems you will touch most Owner, CEO and board Business development and export sales: the European essentials in one course Business development and export sales Business development and export sales: the first month in a pharma company, from zero Business development and export sales Business development and export sales: working with European counterparts day to day Business development and export sales Business development and export sales: the ten documents and systems you will touch most Business development and export sales Regulatory affairs: the European essentials in one course Regulatory affairs Regulatory affairs: the first month in a pharma company, from zero Regulatory affairs Regulatory affairs: working with European counterparts day to day Regulatory affairs Regulatory affairs: the ten documents and systems you will touch most Regulatory affairs Quality assurance and Qualified Person: the European essentials in one course Quality assurance and Qualified Person Quality assurance and Qualified Person: the first month in a pharma company, from zero Quality assurance and Qualified Person Quality assurance and Qualified Person: working with European counterparts day to day Quality assurance and Qualified Person Quality assurance and Qualified Person: the ten documents and systems you will touch most Quality assurance and Qualified Person Quality control and laboratory: the European essentials in one course Quality control and laboratory Quality control and laboratory: the first month in a pharma company, from zero Quality control and laboratory Quality control and laboratory: working with European counterparts day to day Quality control and laboratory Quality control and laboratory: the ten documents and systems you will touch most Quality control and laboratory Production and engineering: the European essentials in one course Production and engineering Production and engineering: the first month in a pharma company, from zero Production and engineering Production and engineering: working with European counterparts day to day Production and engineering Production and engineering: the ten documents and systems you will touch most Production and engineering Supply chain, purchasing and logistics: the European essentials in one course Supply chain, purchasing and logistics Supply chain, purchasing and logistics: the first month in a pharma company, from zero Supply chain, purchasing and logistics Supply chain, purchasing and logistics: working with European counterparts day to day Supply chain, purchasing and logistics Supply chain, purchasing and logistics: the ten documents and systems you will touch most Supply chain, purchasing and logistics Finance, pricing and tenders: the European essentials in one course Finance, pricing and tenders Finance, pricing and tenders: the first month in a pharma company, from zero Finance, pricing and tenders Finance, pricing and tenders: working with European counterparts day to day Finance, pricing and tenders Finance, pricing and tenders: the ten documents and systems you will touch most Finance, pricing and tenders Marketing and communications: the European essentials in one course Marketing and communications Marketing and communications: the first month in a pharma company, from zero Marketing and communications Marketing and communications: working with European counterparts day to day Marketing and communications Marketing and communications: the ten documents and systems you will touch most Marketing and communications Pharmacovigilance and medical: the European essentials in one course Pharmacovigilance and medical Pharmacovigilance and medical: the first month in a pharma company, from zero Pharmacovigilance and medical Pharmacovigilance and medical: working with European counterparts day to day Pharmacovigilance and medical Pharmacovigilance and medical: the ten documents and systems you will touch most Pharmacovigilance and medical Human resources and onboarding: the European essentials in one course Human resources and onboarding Human resources and onboarding: the first month in a pharma company, from zero Human resources and onboarding Human resources and onboarding: working with European counterparts day to day Human resources and onboarding Human resources and onboarding: the ten documents and systems you will touch most Human resources and onboarding IT, data and validation: the European essentials in one course IT, data and validation IT, data and validation: the first month in a pharma company, from zero IT, data and validation IT, data and validation: working with European counterparts day to day IT, data and validation IT, data and validation: the ten documents and systems you will touch most IT, data and validation Selling into Europe as a api and intermediates maker from India India, API and intermediates maker Selling into Europe as a contract manufacturer (cdmo / cmo) from India India, Contract manufacturer (CDMO / CMO) Selling into Europe as a finished-dose generic company from India India, Finished-dose generic company Selling into Europe as a biologics and biosimilars from India India, Biologics and biosimilars Selling into Europe as a excipient supplier from India India, Excipient supplier Selling into Europe as a packaging and machinery supplier from India India, Packaging and machinery supplier Selling into Europe as a nutraceutical and natural products from India India, Nutraceutical and natural products Selling into Europe as a trader, distributor, wholesaler from India India, Trader, distributor, wholesaler Selling into Europe as a regulatory and qa consultancy from India India, Regulatory and QA consultancy Selling into Europe as a cro and analytical laboratory from India India, CRO and analytical laboratory Selling into Europe as a pharma software and ai vendor from India India, Pharma software and AI vendor Selling into Europe as a pharma logistics and cold chain from India India, Pharma logistics and cold chain Selling into Europe as a api and intermediates maker from China China, API and intermediates maker Selling into Europe as a contract manufacturer (cdmo / cmo) from China China, Contract manufacturer (CDMO / CMO) Selling into Europe as a finished-dose generic company from China China, Finished-dose generic company Selling into Europe as a biologics and biosimilars from China China, Biologics and biosimilars Selling into Europe as a excipient supplier from China China, Excipient supplier Selling into Europe as a packaging and machinery supplier from China China, Packaging and machinery supplier Selling into Europe as a nutraceutical and natural products from China China, Nutraceutical and natural products Selling into Europe as a trader, distributor, wholesaler from China China, Trader, distributor, wholesaler Selling into Europe as a regulatory and qa consultancy from China China, Regulatory and QA consultancy Selling into Europe as a cro and analytical laboratory from China China, CRO and analytical laboratory Selling into Europe as a pharma software and ai vendor from China China, Pharma software and AI vendor Selling into Europe as a pharma logistics and cold chain from China China, Pharma logistics and cold chain Selling into Europe as a api and intermediates maker from Türkiye Türkiye, API and intermediates maker Selling into Europe as a contract manufacturer (cdmo / cmo) from Türkiye Türkiye, Contract manufacturer (CDMO / CMO) Selling into Europe as a finished-dose generic company from Türkiye Türkiye, Finished-dose generic company Selling into Europe as a biologics and biosimilars from Türkiye Türkiye, Biologics and biosimilars Selling into Europe as a excipient supplier from Türkiye Türkiye, Excipient supplier Selling into Europe as a packaging and machinery supplier from Türkiye Türkiye, Packaging and machinery supplier Selling into Europe as a nutraceutical and natural products from Türkiye Türkiye, Nutraceutical and natural products Selling into Europe as a trader, distributor, wholesaler from Türkiye Türkiye, Trader, distributor, wholesaler Selling into Europe as a regulatory and qa consultancy from Türkiye Türkiye, Regulatory and QA consultancy Selling into Europe as a cro and analytical laboratory from Türkiye Türkiye, CRO and analytical laboratory Selling into Europe as a pharma software and ai vendor from Türkiye Türkiye, Pharma software and AI vendor Selling into Europe as a pharma logistics and cold chain from Türkiye Türkiye, Pharma logistics and cold chain Selling into Europe as a api and intermediates maker from Korea Korea, API and intermediates maker Selling into Europe as a contract manufacturer (cdmo / cmo) from Korea Korea, Contract manufacturer (CDMO / CMO) Selling into Europe as a finished-dose generic company from Korea Korea, Finished-dose generic company Selling into Europe as a biologics and biosimilars from Korea Korea, Biologics and biosimilars Selling into Europe as a excipient supplier from Korea Korea, Excipient supplier Selling into Europe as a packaging and machinery supplier from Korea Korea, Packaging and machinery supplier Selling into Europe as a nutraceutical and natural products from Korea Korea, Nutraceutical and natural products Selling into Europe as a trader, distributor, wholesaler from Korea Korea, Trader, distributor, wholesaler Selling into Europe as a regulatory and qa consultancy from Korea Korea, Regulatory and QA consultancy Selling into Europe as a cro and analytical laboratory from Korea Korea, CRO and analytical laboratory Selling into Europe as a pharma software and ai vendor from Korea Korea, Pharma software and AI vendor Selling into Europe as a pharma logistics and cold chain from Korea Korea, Pharma logistics and cold chain Selling into Europe as a api and intermediates maker from Japan Japan, API and intermediates maker Selling into Europe as a contract manufacturer (cdmo / cmo) from Japan Japan, Contract manufacturer (CDMO / CMO) Selling into Europe as a finished-dose generic company from Japan Japan, Finished-dose generic company Selling into Europe as a biologics and biosimilars from Japan Japan, Biologics and biosimilars Selling into Europe as a excipient supplier from Japan Japan, Excipient supplier Selling into Europe as a packaging and machinery supplier from Japan Japan, Packaging and machinery supplier Selling into Europe as a nutraceutical and natural products from Japan Japan, Nutraceutical and natural products Selling into Europe as a trader, distributor, wholesaler from Japan Japan, Trader, distributor, wholesaler Selling into Europe as a regulatory and qa consultancy from Japan Japan, Regulatory and QA consultancy Selling into Europe as a cro and analytical laboratory from Japan Japan, CRO and analytical laboratory Selling into Europe as a pharma software and ai vendor from Japan Japan, Pharma software and AI vendor Selling into Europe as a pharma logistics and cold chain from Japan Japan, Pharma logistics and cold chain Selling into Europe as a api and intermediates maker from Taiwan Taiwan, API and intermediates maker Selling into Europe as a contract manufacturer (cdmo / cmo) from Taiwan Taiwan, Contract manufacturer (CDMO / CMO) Selling into Europe as a finished-dose generic company from Taiwan Taiwan, Finished-dose generic company Selling into Europe as a biologics and biosimilars 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distributor, wholesaler Selling into Europe as a regulatory and qa consultancy from United States United States, Regulatory and QA consultancy Selling into Europe as a cro and analytical laboratory from United States United States, CRO and analytical laboratory Selling into Europe as a pharma software and ai vendor from United States United States, Pharma software and AI vendor Selling into Europe as a pharma logistics and cold chain from United States United States, Pharma logistics and cold chain Your company in Europe: a custom onboarding course built from your products, sites and customers All staff, HR Your products, explained for your sales team: regulatory status, competitors, buyers per European country BD, marketing Your quality system, taught: the client's own SOPs as a course with assessments All technical staff Your inspection readiness: a course built from the client's last audit findings QA, production Your European launch plan as a course: so every employee knows the plan All staff
Not finding the exact title? Tell us the role and the gap and we point you to the right course. Ask on WhatsApp
Every course, every role, the same six things
Not just the sales team. The quality manager who faces the auditor, the regulatory officer who files the dossier, the production lead who signs the batch record, the finance person who reads the contract, the new hire who starts on Monday.
- One-hour audio modules. Listen on the commute, at the bench, in the car.
- 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.
Who makes this
The courses are produced by a professor of quantitative finance at Carnegie Mellon University who also owns UAB Clusi Pharma, a licensed pharmaceutical wholesaler in the European Union. The lectures are written and delivered by Pharma Lectures. The wholesaler is where the material is tested against real European buyers and real inspectors.
Why a sample first
Because a one-hour module with its workbook and transcript tells you more than any brochure. Send the role, we send the module. No invoice, no form, no call.
Request a free sample moduleEnglish first. Other languages are available in test mode on request.
Pricing in one breath
Single course€390 per moduleone-hour modules, whole company, 12 months
Track pack, 5 titles€9,900one country, business or role track
Company library€19,900/year12 titles a year, you choose
Custom coursefrom €25,000built from your own procedures and products
Prices for companies under 50 staff, per legal entity, never per seat. Full pricing
1
Ask for the sample
One WhatsApp message with your company and the role. You receive a complete one-hour module.
2
Pick the course
Use the finder above or let us suggest. One price for everyone in the company.
3
Train, certify, file
Delivered within 72 hours of payment. Certificates per learner and the training record land in your quality file.