PharmaLectures

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Foundations: how a regulated pharma market works, Europe as the worked example

6 modules · 6 hours How medicines reach a European patient: the whole chain from API to pharmacy All staff, new hires 6 modules · 6 hours The European Union for pharma people: EMA, national agencies, EDQM, the Commission, who decides what All staff 8 modules · 8 hours Centralised, decentralised, mutual recognition and national procedures explained RA, BD, management 8 modules · 8 hours The marketing authorisation holder: what the MAH must do every year RA, QA, management 20 modules · 20 hours Good Manufacturing Practice from zero: EudraLex Volume 4 read chapter by chapter All technical staff 12 modules · 12 hours Good Distribution Practice from zero: the 2013 EU guideline read article by article Traders, logistics, QA 6 modules · 6 hours The Qualified Person: why one signature controls every batch sold in Europe Management, QA, BD 5 modules · 5 hours The Responsible Person for distribution: duties, liability, how to work with one Traders, wholesalers 10 modules · 10 hours EU inspections: how an EMA or national GMP inspection runs, day by day QA, production, management 6 modules · 6 hours Falsified Medicines Directive and serialisation: what every box must carry Packaging, supply chain, IT 6 modules · 6 hours Pharmacovigilance for non-specialists: what a QPPV does and why your company needs one Management, BD, PV 6 modules · 6 hours Medical devices and combination products: when a product falls under MDR instead RA, BD 10 modules · 10 hours European pharmaceutical pricing and reimbursement: how a price is set in each big market BD, finance, management 12 modules · 12 hours Hospital tenders in Europe: how public procurement of medicines works BD, finance 8 modules · 8 hours Named-patient and unlicensed supply: the legal routes to sell without an authorisation BD, RA, traders 15 modules · 15 hours The European generic market by country: Germany, France, Italy, Spain, Poland, Nordics, Baltics, Balkans BD, management 10 modules · 10 hours European contract law for supply, quality and distribution agreements BD, legal, management 6 modules · 6 hours The Quality Agreement and the Technical Agreement: every clause explained QA, BD, CDMO staff 8 modules · 8 hours Data integrity: ALCOA+, audit trails and what inspectors look for QC, QA, IT, production 12 modules · 12 hours Annex 1 sterile manufacturing 2022: what changed and what inspectors now ask Production, QA, engineering 6 modules · 6 hours Nitrosamines: risk assessment, testing and reporting in the EU QC, RA, API staff 8 modules · 8 hours Environmental and social reporting for pharma suppliers: CSRD, EcoVadis, PSCI audits Management, QA, sales 8 modules · 8 hours The EU AI Act and computerised systems: Annex 11 and GAMP 5 for pharma IT, QA, validation 10 modules · 10 hours Pharma English: writing deviations, CAPAs, emails and reports a European reader trusts All staff 12 modules · 12 hours Business English for pharma sales: calls, meetings, trade-show conversations, negotiations BD, sales, marketing

Regulatory affairs by region

15 modules · 15 hours European Union: CTD and eCTD for the EU: building a dossier that passes validation RA, QA, BD 12 modules · 12 hours European Union: Active Substance Master File and Certificate of Suitability (CEP): the two roads into Europe for an API RA, QA, BD 10 modules · 10 hours European Union: Variations, renewals and lifecycle management in the EU RA, QA, BD 8 modules · 8 hours European Union: GMP certificates, written confirmations and the Article 46b rules for third-country API RA, QA, BD 10 modules · 10 hours European Union: Importation into the EU: the importer licence, QP release and batch testing on arrival RA, QA, BD 12 modules · 12 hours European Union: Biosimilars in the EU: comparability, extrapolation and the EMA pathway RA, QA, BD 6 modules · 6 hours European Union: Paediatric, orphan and hybrid applications: when they apply to a generic company RA, QA, BD 5 modules · 5 hours European Union: The EU pharmaceutical legislation reform: what changes for exporters RA, QA, BD 6 modules · 6 hours European Union: EU excipient rules: novel excipients, risk assessment under the 2015 guideline RA, QA, BD 10 modules · 10 hours European Union: Clinical trials in the EU: CTIS and Regulation 536/2014 for CRO and sponsor staff RA, QA, BD 8 modules · 8 hours European Union: UK after Brexit: MHRA licensing, Windsor Framework, UK Responsible Person RA, QA, BD 5 modules · 5 hours European Union: Switzerland: Swissmedic and how it differs from the EU RA, QA, BD 15 modules · 15 hours United States: ANDA from A to Z: filing a generic with the FDA RA, QA, BD 10 modules · 10 hours United States: Type II Drug Master Files and the GDUFA fee system RA, QA, BD 10 modules · 10 hours United States: FDA inspections of foreign sites: Form 483, warning letters, import alerts RA, QA, BD 8 modules · 8 hours United States: 21 CFR 210 and 211 versus EU GMP: the differences that catch exporters RA, QA, BD 8 modules · 8 hours United States: 505(b)(2) and NDA basics for differentiated generics RA, QA, BD 6 modules · 6 hours United States: US supply-chain security act (DSCSA) for exporters and distributors RA, QA, BD 10 modules · 10 hours United States: US pricing, group purchasing organisations and the generic distribution channel RA, QA, BD 12 modules · 12 hours Latin America: Brazil ANVISA: registration, GMP certification of foreign sites and the inspection queue RA, QA, BD 10 modules · 10 hours Latin America: Mexico COFEPRIS: registration, third-party pre-review and the health licence RA, QA, BD 12 modules · 12 hours Latin America: Colombia INVIMA, Peru DIGEMID, Chile ISP, Argentina ANMAT: a working comparison RA, QA, BD 8 modules · 8 hours Latin America: Selling to Latin American hospital tenders and public health buyers RA, QA, BD 10 modules · 10 hours Middle East and Africa: Saudi SFDA and the Gulf registration route RA, QA, BD 8 modules · 8 hours Middle East and Africa: Egypt EDA, Algeria, Morocco: North African registration RA, QA, BD 8 modules · 8 hours Middle East and Africa: South Africa SAHPRA and the African Medicines Agency RA, QA, BD 10 modules · 10 hours Middle East and Africa: WHO prequalification: what it unlocks and how to get it RA, QA, BD 12 modules · 12 hours Asia Pacific: China NMPA for foreign companies: registration, DMF and the 2019 reform RA, QA, BD 10 modules · 10 hours Asia Pacific: Japan PMDA and the accreditation of foreign manufacturers RA, QA, BD 8 modules · 8 hours Asia Pacific: ASEAN and Australia TGA: harmonised CTD and GMP clearance RA, QA, BD 8 modules · 8 hours Asia Pacific: Korea MFDS registration and GMP for foreign sites RA, QA, BD

Quality, compliance and operations

12 modules · 12 hours Pharmaceutical Quality System (ICH Q10) built from scratch for a small or mid-sized company QA, management 10 modules · 10 hours Deviations, CAPA and root cause analysis that satisfy a European inspector QA, production 8 modules · 8 hours Change control and risk management (ICH Q9) in daily practice QA, production 10 modules · 10 hours Supplier qualification and auditing: how Europeans will audit you and how you audit others QA, purchasing 12 modules · 12 hours Process validation, cleaning validation and continued process verification Production, QA, engineering 10 modules · 10 hours Analytical method validation and transfer (ICH Q2 R2 and Q14) QC 8 modules · 8 hours Stability studies for the EU and ICH zones: design, storage, reporting QC, RA 6 modules · 6 hours Out-of-specification and out-of-trend results: the investigation an inspector expects QC, QA 10 modules · 10 hours Computerised system validation and the move to cloud systems IT, QA 10 modules · 10 hours Pharmaceutical microbiology and environmental monitoring QC, production 6 modules · 6 hours Elemental impurities (ICH Q3D) and residual solvents for API and finished dose QC, RA 6 modules · 6 hours Good documentation practice and batch record review All technical staff 10 modules · 10 hours Qualification of equipment, utilities and facilities (URS to PQ) Engineering, QA 8 modules · 8 hours Handling a European customer audit: the two days, the report, the response QA, management, sales 8 modules · 8 hours Handling an EU or FDA inspection remotely and on site: roles, back room, answers QA, management 6 modules · 6 hours Writing SOPs that people follow and inspectors accept QA, all technical staff 8 modules · 8 hours Temperature-controlled storage and transport: mapping, excursions, qualification Logistics, QA 6 modules · 6 hours Returns, recalls, complaints and falsified product handling QA, logistics, sales 10 modules · 10 hours Contamination control strategy under the new Annex 1 Production, QA 8 modules · 8 hours Continuous manufacturing and ICH Q13 for companies planning the step Engineering, management 8 modules · 8 hours GMP for excipients and the IPEC and EXCiPACT schemes Excipient suppliers 15 modules · 15 hours GMP for API: ICH Q7 chapter by chapter API staff 12 modules · 12 hours GMP for biologics: Part II Annex 2 and the differences from small molecules Biologics staff 8 modules · 8 hours GMP for investigational products and clinical supply CRO, CDMO

Commercial: winning and keeping customers abroad

8 modules · 8 hours How a European buyer chooses a supplier: the real scorecard, from audit to price BD, management 10 modules · 10 hours Finding, qualifying and approaching European customers without an agent BD 6 modules · 6 hours Trade-show selling: before the show, at the stand, and the follow-up BD, marketing 8 modules · 8 hours Pricing for Europe: landed cost, Incoterms, currency, margin stacking through the chain BD, finance 12 modules · 12 hours Winning European hospital tenders: reading a call, bidding, supply guarantees, penalties BD, finance 8 modules · 8 hours Dossier licensing and out-licensing: selling a registered dossier to a European MAH BD, RA 10 modules · 10 hours Contract manufacturing sales: how a CDMO wins and keeps a European client CDMO BD 8 modules · 8 hours Distribution agreements, exclusivity, territory and termination in Europe BD, legal 8 modules · 8 hours Key account management for a long-term European customer BD, sales 8 modules · 8 hours Export documents, customs, VAT, duty and the EU importer of record Logistics, finance, sales 6 modules · 6 hours Payment terms, letters of credit, credit insurance and getting paid by Europeans Finance, sales 8 modules · 8 hours Building a European subsidiary or branch: when, where, cost and licences Management 6 modules · 6 hours Partnering with a European wholesaler or licence holder: the named-patient and early-access model BD, management 10 modules · 10 hours Digital demand generation for pharma B2B: search, LinkedIn, email, trade directories Marketing, BD 6 modules · 6 hours Writing a company profile, product list and capability deck Europeans take seriously Marketing, BD 5 modules · 5 hours Reputation, shortages and the opportunity for new suppliers in Europe Management, BD

Nationality tracks

8 modules · 8 hours Selling to Europeans when you are from India: culture, expectations and the mistakes that lose deals India companies 5 modules · 5 hours How Europeans see suppliers from India: reputation, prejudice and how to turn it around India companies 8 modules · 8 hours India regulatory system versus the EU: a side-by-side for RA and QA staff India companies 10 modules · 10 hours From India GMP to EU GMP: the gap list and how to close it India companies 8 modules · 8 hours Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from India India companies 6 modules · 6 hours Email, calls and meetings in English for India teams: tone, directness, follow-up India companies 5 modules · 5 hours Case studies: India companies that succeeded in Europe and what they did differently India companies 6 modules · 6 hours First 90 days of a India export manager assigned to Europe India companies 8 modules · 8 hours Selling to Europeans when you are from China: culture, expectations and the mistakes that lose deals China companies 5 modules · 5 hours How Europeans see suppliers from China: reputation, prejudice and how to turn it around China companies 8 modules · 8 hours China regulatory system versus the EU: a side-by-side for RA and QA staff China companies 10 modules · 10 hours From China GMP to EU GMP: the gap list and how to close it China companies 8 modules · 8 hours Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from China China companies 6 modules · 6 hours Email, calls and meetings in English for China teams: tone, directness, follow-up China companies 5 modules · 5 hours Case studies: China companies that succeeded in Europe and what they did differently China companies 6 modules · 6 hours First 90 days of a China export manager assigned to Europe China companies 8 modules · 8 hours Selling to Europeans when you are from Türkiye: culture, expectations and the mistakes that lose deals Türkiye companies 5 modules · 5 hours How Europeans see suppliers from Türkiye: reputation, prejudice and how to turn it around Türkiye companies 8 modules · 8 hours Türkiye regulatory system versus the EU: a side-by-side for RA and QA staff Türkiye companies 10 modules · 10 hours From Türkiye GMP to EU GMP: the gap list and how to close it Türkiye companies 8 modules · 8 hours Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Türkiye Türkiye companies 6 modules · 6 hours Email, calls and meetings in English for Türkiye teams: tone, directness, follow-up Türkiye companies 5 modules · 5 hours Case studies: Türkiye companies that succeeded in Europe and what they did differently Türkiye companies 6 modules · 6 hours First 90 days of a Türkiye export manager assigned to Europe Türkiye companies 8 modules · 8 hours Selling to Europeans when you are from Korea: culture, expectations and the mistakes that lose deals Korea companies 5 modules · 5 hours How Europeans see suppliers from Korea: reputation, prejudice and how to turn it around Korea companies 8 modules · 8 hours Korea regulatory system versus the EU: a side-by-side for RA and QA staff Korea companies 10 modules · 10 hours From Korea GMP to EU GMP: the gap list and how to close it Korea companies 8 modules · 8 hours Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Korea Korea companies 6 modules · 6 hours Email, calls and meetings in English for Korea teams: tone, directness, follow-up Korea companies 5 modules · 5 hours Case studies: Korea companies that succeeded in Europe and what they did differently Korea companies 6 modules · 6 hours First 90 days of a Korea export manager assigned to Europe Korea companies 8 modules · 8 hours Selling to Europeans when you are from Japan: culture, expectations and the mistakes that lose deals Japan companies 5 modules · 5 hours How Europeans see suppliers from Japan: reputation, prejudice and how to turn it around Japan companies 8 modules · 8 hours Japan regulatory system versus the EU: a side-by-side for RA and QA staff Japan companies 10 modules · 10 hours From Japan GMP to EU GMP: the gap list and how to close it Japan companies 8 modules · 8 hours Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Japan Japan companies 6 modules · 6 hours Email, calls and meetings in English for Japan teams: tone, directness, follow-up Japan companies 5 modules · 5 hours Case studies: Japan companies that succeeded in Europe and what they did differently Japan companies 6 modules · 6 hours First 90 days of a Japan export manager assigned to Europe Japan companies 8 modules · 8 hours Selling to Europeans when you are from Taiwan: culture, expectations and the mistakes that lose deals Taiwan companies 5 modules · 5 hours How Europeans see suppliers from Taiwan: reputation, prejudice and how to turn it around Taiwan companies 8 modules · 8 hours Taiwan regulatory system versus the EU: a side-by-side for RA and QA staff Taiwan companies 10 modules · 10 hours From Taiwan GMP to EU GMP: the gap list and how to close it Taiwan companies 8 modules · 8 hours Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Taiwan Taiwan companies 6 modules · 6 hours Email, calls and meetings in English for Taiwan teams: tone, directness, follow-up Taiwan companies 5 modules · 5 hours Case studies: Taiwan companies that succeeded in Europe and what they did differently Taiwan companies 6 modules · 6 hours First 90 days of a Taiwan export manager assigned to Europe Taiwan companies 8 modules · 8 hours Selling to Europeans when you are from Egypt, Gulf and MENA: culture, expectations and the mistakes that lose deals Egypt, Gulf and MENA companies 5 modules · 5 hours How Europeans see suppliers from Egypt, Gulf and MENA: reputation, prejudice and how to turn it around Egypt, Gulf and MENA companies 8 modules · 8 hours Egypt, Gulf and MENA regulatory system versus the EU: a side-by-side for RA and QA staff Egypt, Gulf and MENA companies 10 modules · 10 hours From Egypt, Gulf and MENA GMP to EU GMP: the gap list and how to close it Egypt, Gulf and MENA companies 8 modules · 8 hours Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Egypt, Gulf and MENA Egypt, Gulf and MENA companies 6 modules · 6 hours Email, calls and meetings in English for Egypt, Gulf and MENA teams: tone, directness, follow-up Egypt, Gulf and MENA companies 5 modules · 5 hours Case studies: Egypt, Gulf and MENA companies that succeeded in Europe and what they did differently Egypt, Gulf and MENA companies 6 modules · 6 hours First 90 days of a Egypt, Gulf and MENA export manager assigned to Europe Egypt, Gulf and MENA companies 8 modules · 8 hours Selling to Europeans when you are from Brazil and Latin America: culture, expectations and the mistakes that lose deals Brazil and Latin America companies 5 modules · 5 hours How Europeans see suppliers from Brazil and Latin America: reputation, prejudice and how to turn it around Brazil and Latin America companies 8 modules · 8 hours Brazil and Latin America regulatory system versus the EU: a side-by-side for RA and QA staff Brazil and Latin America companies 10 modules · 10 hours From Brazil and Latin America GMP to EU GMP: the gap list and how to close it Brazil and Latin America companies 8 modules · 8 hours Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Brazil and Latin America Brazil and Latin America companies 6 modules · 6 hours Email, calls and meetings in English for Brazil and Latin America teams: tone, directness, follow-up Brazil and Latin America companies 5 modules · 5 hours Case studies: Brazil and Latin America companies that succeeded in Europe and what they did differently Brazil and Latin America companies 6 modules · 6 hours First 90 days of a Brazil and Latin America export manager assigned to Europe Brazil and Latin America companies 8 modules · 8 hours Selling to Europeans when you are from Pakistan, Bangladesh and Vietnam: culture, expectations and the mistakes that lose deals Pakistan, Bangladesh and Vietnam companies 5 modules · 5 hours How Europeans see suppliers from Pakistan, Bangladesh and Vietnam: reputation, prejudice and how to turn it around Pakistan, Bangladesh and Vietnam companies 8 modules · 8 hours Pakistan, Bangladesh and Vietnam regulatory system versus the EU: a side-by-side for RA and QA staff Pakistan, Bangladesh and Vietnam companies 10 modules · 10 hours From Pakistan, Bangladesh and Vietnam GMP to EU GMP: the gap list and how to close it Pakistan, Bangladesh and Vietnam companies 8 modules · 8 hours Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam companies 6 modules · 6 hours Email, calls and meetings in English for Pakistan, Bangladesh and Vietnam teams: tone, directness, follow-up Pakistan, Bangladesh and Vietnam companies 5 modules · 5 hours Case studies: Pakistan, Bangladesh and Vietnam companies that succeeded in Europe and what they did differently Pakistan, Bangladesh and Vietnam companies 6 modules · 6 hours First 90 days of a Pakistan, Bangladesh and Vietnam export manager assigned to Europe Pakistan, Bangladesh and Vietnam companies 8 modules · 8 hours Selling to Europeans when you are from United States: culture, expectations and the mistakes that lose deals United States companies 5 modules · 5 hours How Europeans see suppliers from United States: reputation, prejudice and how to turn it around United States companies 8 modules · 8 hours United States regulatory system versus the EU: a side-by-side for RA and QA staff United States companies 10 modules · 10 hours From United States GMP to EU GMP: the gap list and how to close it United States companies 8 modules · 8 hours Negotiating with Germans, French, Italians, Spaniards, Nordics and Eastern Europeans when you are from United States United States companies 6 modules · 6 hours Email, calls and meetings in English for United States teams: tone, directness, follow-up United States companies 5 modules · 5 hours Case studies: United States companies that succeeded in Europe and what they did differently United States companies 6 modules · 6 hours First 90 days of a United States export manager assigned to Europe United States companies

Niche playbooks

12 modules · 12 hours Europe playbook for the API and intermediates maker: licences, documents, customers, timeline, cost API and intermediates maker 8 modules · 8 hours What European customers audit at the API and intermediates maker: the checklist API and intermediates maker 8 modules · 8 hours The regulatory file a European buyer asks the API and intermediates maker for, and how to prepare it API and intermediates maker 6 modules · 6 hours Pricing and contracts in Europe for the API and intermediates maker API and intermediates maker 10 modules · 10 hours Onboarding a new hire at the API and intermediates maker: company, industry and Europe in one week API and intermediates maker 12 modules · 12 hours Europe playbook for the contract manufacturer (CDMO / CMO): licences, documents, customers, timeline, cost Contract manufacturer (CDMO / CMO) 8 modules · 8 hours What European customers audit at the contract manufacturer (CDMO / CMO): the checklist Contract manufacturer (CDMO / CMO) 8 modules · 8 hours The regulatory file a European buyer asks the contract manufacturer (CDMO / CMO) for, and how to prepare it Contract manufacturer (CDMO / CMO) 6 modules · 6 hours Pricing and contracts in Europe for the contract manufacturer (CDMO / CMO) Contract manufacturer (CDMO / CMO) 10 modules · 10 hours Onboarding a new hire at the contract manufacturer (CDMO / CMO): company, industry and Europe in one week Contract manufacturer (CDMO / CMO) 12 modules · 12 hours Europe playbook for the finished-dose generic company: licences, documents, customers, timeline, cost Finished-dose generic company 8 modules · 8 hours What European customers audit at the finished-dose generic company: the checklist Finished-dose generic company 8 modules · 8 hours The regulatory file a European buyer asks the finished-dose generic company for, and how to prepare it Finished-dose generic company 6 modules · 6 hours Pricing and contracts in Europe for the finished-dose generic company Finished-dose generic company 10 modules · 10 hours Onboarding a new hire at the finished-dose generic company: company, industry and Europe in one week Finished-dose generic company 12 modules · 12 hours Europe playbook for the biologics and biosimilars: licences, documents, customers, timeline, cost Biologics and biosimilars 8 modules · 8 hours What European customers audit at the biologics and biosimilars: the checklist Biologics and biosimilars 8 modules · 8 hours The regulatory file a European buyer asks the biologics and biosimilars for, and how to prepare it Biologics and biosimilars 6 modules · 6 hours Pricing and contracts in Europe for the biologics and biosimilars Biologics and biosimilars 10 modules · 10 hours Onboarding a new hire at the biologics and biosimilars: company, industry and Europe in one week Biologics and biosimilars 12 modules · 12 hours Europe playbook for the excipient supplier: licences, documents, customers, timeline, cost Excipient supplier 8 modules · 8 hours What European customers audit at the excipient supplier: the checklist Excipient supplier 8 modules · 8 hours The regulatory file a European buyer asks the excipient supplier for, and how to prepare it Excipient supplier 6 modules · 6 hours Pricing and contracts in Europe for the excipient supplier Excipient supplier 10 modules · 10 hours Onboarding a new hire at the excipient supplier: company, industry and Europe in one week Excipient supplier 12 modules · 12 hours Europe playbook for the packaging and machinery supplier: licences, documents, customers, timeline, cost Packaging and machinery supplier 8 modules · 8 hours What European customers audit at the packaging and machinery supplier: the checklist Packaging and machinery supplier 8 modules · 8 hours The regulatory file a European buyer asks the packaging and machinery supplier for, and how to prepare it Packaging and machinery supplier 6 modules · 6 hours Pricing and contracts in Europe for the packaging and machinery supplier Packaging and machinery supplier 10 modules · 10 hours Onboarding a new hire at the packaging and machinery supplier: company, industry and Europe in one week Packaging and machinery supplier 12 modules · 12 hours Europe playbook for the nutraceutical and natural products: licences, documents, customers, timeline, cost Nutraceutical and natural products 8 modules · 8 hours What European customers audit at the nutraceutical and natural products: the checklist Nutraceutical and natural products 8 modules · 8 hours The regulatory file a European buyer asks the nutraceutical and natural products for, and how to prepare it Nutraceutical and natural products 6 modules · 6 hours Pricing and contracts in Europe for the nutraceutical and natural products Nutraceutical and natural products 10 modules · 10 hours Onboarding a new hire at the nutraceutical and natural products: company, industry and Europe in one week Nutraceutical and natural products 12 modules · 12 hours Europe playbook for the trader, distributor, wholesaler: licences, documents, customers, timeline, cost Trader, distributor, wholesaler 8 modules · 8 hours What European customers audit at the trader, distributor, wholesaler: the checklist Trader, distributor, wholesaler 8 modules · 8 hours The regulatory file a European buyer asks the trader, distributor, wholesaler for, and how to prepare it Trader, distributor, wholesaler 6 modules · 6 hours Pricing and contracts in Europe for the trader, distributor, wholesaler Trader, distributor, wholesaler 10 modules · 10 hours Onboarding a new hire at the trader, distributor, wholesaler: company, industry and Europe in one week Trader, distributor, wholesaler 12 modules · 12 hours Europe playbook for the regulatory and QA consultancy: licences, documents, customers, timeline, cost Regulatory and QA consultancy 8 modules · 8 hours What European customers audit at the regulatory and QA consultancy: the checklist Regulatory and QA consultancy 8 modules · 8 hours The regulatory file a European buyer asks the regulatory and QA consultancy for, and how to prepare it Regulatory and QA consultancy 6 modules · 6 hours Pricing and contracts in Europe for the regulatory and QA consultancy Regulatory and QA consultancy 10 modules · 10 hours Onboarding a new hire at the regulatory and QA consultancy: company, industry and Europe in one week Regulatory and QA consultancy 12 modules · 12 hours Europe playbook for the CRO and analytical laboratory: licences, documents, customers, timeline, cost CRO and analytical laboratory 8 modules · 8 hours What European customers audit at the CRO and analytical laboratory: the checklist CRO and analytical laboratory 8 modules · 8 hours The regulatory file a European buyer asks the CRO and analytical laboratory for, and how to prepare it CRO and analytical laboratory 6 modules · 6 hours Pricing and contracts in Europe for the CRO and analytical laboratory CRO and analytical laboratory 10 modules · 10 hours Onboarding a new hire at the CRO and analytical laboratory: company, industry and Europe in one week CRO and analytical laboratory 12 modules · 12 hours Europe playbook for the pharma software and AI vendor: licences, documents, customers, timeline, cost Pharma software and AI vendor 8 modules · 8 hours What European customers audit at the pharma software and AI vendor: the checklist Pharma software and AI vendor 8 modules · 8 hours The regulatory file a European buyer asks the pharma software and AI vendor for, and how to prepare it Pharma software and AI vendor 6 modules · 6 hours Pricing and contracts in Europe for the pharma software and AI vendor Pharma software and AI vendor 10 modules · 10 hours Onboarding a new hire at the pharma software and AI vendor: company, industry and Europe in one week Pharma software and AI vendor 12 modules · 12 hours Europe playbook for the pharma logistics and cold chain: licences, documents, customers, timeline, cost Pharma logistics and cold chain 8 modules · 8 hours What European customers audit at the pharma logistics and cold chain: the checklist Pharma logistics and cold chain 8 modules · 8 hours The regulatory file a European buyer asks the pharma logistics and cold chain for, and how to prepare it Pharma logistics and cold chain 6 modules · 6 hours Pricing and contracts in Europe for the pharma logistics and cold chain Pharma logistics and cold chain 10 modules · 10 hours Onboarding a new hire at the pharma logistics and cold chain: company, industry and Europe in one week Pharma logistics and cold chain

Role tracks

10 modules · 10 hours Owner, CEO and board: the European essentials in one course Owner, CEO and board 8 modules · 8 hours Owner, CEO and board: the first month in a pharma company, from zero Owner, CEO and board 6 modules · 6 hours Owner, CEO and board: working with European counterparts day to day Owner, CEO and board 5 modules · 5 hours Owner, CEO and board: the ten documents and systems you will touch most Owner, CEO and board 10 modules · 10 hours Business development and export sales: the European essentials in one course Business development and export sales 8 modules · 8 hours Business development and export sales: the first month in a pharma company, from zero Business development and export sales 6 modules · 6 hours Business development and export sales: working with European counterparts day to day Business development and export sales 5 modules · 5 hours Business development and export sales: the ten documents and systems you will touch most Business development and export sales 10 modules · 10 hours Regulatory affairs: the European essentials in one course Regulatory affairs 8 modules · 8 hours Regulatory affairs: the first month in a pharma company, from zero Regulatory affairs 6 modules · 6 hours Regulatory affairs: working with European counterparts day to day Regulatory affairs 5 modules · 5 hours Regulatory affairs: the ten documents and systems you will touch most Regulatory affairs 10 modules · 10 hours Quality assurance and Qualified Person: the European essentials in one course Quality assurance and Qualified Person 8 modules · 8 hours Quality assurance and Qualified Person: the first month in a pharma company, from zero Quality assurance and Qualified Person 6 modules · 6 hours Quality assurance and Qualified Person: working with European counterparts day to day Quality assurance and Qualified Person 5 modules · 5 hours Quality assurance and Qualified Person: the ten documents and systems you will touch most Quality assurance and Qualified Person 10 modules · 10 hours Quality control and laboratory: the European essentials in one course Quality control and laboratory 8 modules · 8 hours Quality control and laboratory: the first month in a pharma company, from zero Quality control and laboratory 6 modules · 6 hours Quality control and laboratory: working with European counterparts day to day Quality control and laboratory 5 modules · 5 hours Quality control and laboratory: the ten documents and systems you will touch most Quality control and laboratory 10 modules · 10 hours Production and engineering: the European essentials in one course Production and engineering 8 modules · 8 hours Production and engineering: the first month in a pharma company, from zero Production and engineering 6 modules · 6 hours Production and engineering: working with European counterparts day to day Production and engineering 5 modules · 5 hours Production and engineering: the ten documents and systems you will touch most Production and engineering 10 modules · 10 hours Supply chain, purchasing and logistics: the European essentials in one course Supply chain, purchasing and logistics 8 modules · 8 hours Supply chain, purchasing and logistics: the first month in a pharma company, from zero Supply chain, purchasing and logistics 6 modules · 6 hours Supply chain, purchasing and logistics: working with European counterparts day to day Supply chain, purchasing and logistics 5 modules · 5 hours Supply chain, purchasing and logistics: the ten documents and systems you will touch most Supply chain, purchasing and logistics 10 modules · 10 hours Finance, pricing and tenders: the European essentials in one course Finance, pricing and tenders 8 modules · 8 hours Finance, pricing and tenders: the first month in a pharma company, from zero Finance, pricing and tenders 6 modules · 6 hours Finance, pricing and tenders: working with European counterparts day to day Finance, pricing and tenders 5 modules · 5 hours Finance, pricing and tenders: the ten documents and systems you will touch most Finance, pricing and tenders 10 modules · 10 hours Marketing and communications: the European essentials in one course Marketing and communications 8 modules · 8 hours Marketing and communications: the first month in a pharma company, from zero Marketing and communications 6 modules · 6 hours Marketing and communications: working with European counterparts day to day Marketing and communications 5 modules · 5 hours Marketing and communications: the ten documents and systems you will touch most Marketing and communications 10 modules · 10 hours Pharmacovigilance and medical: the European essentials in one course Pharmacovigilance and medical 8 modules · 8 hours Pharmacovigilance and medical: the first month in a pharma company, from zero Pharmacovigilance and medical 6 modules · 6 hours Pharmacovigilance and medical: working with European counterparts day to day Pharmacovigilance and medical 5 modules · 5 hours Pharmacovigilance and medical: the ten documents and systems you will touch most Pharmacovigilance and medical 10 modules · 10 hours Human resources and onboarding: the European essentials in one course Human resources and onboarding 8 modules · 8 hours Human resources and onboarding: the first month in a pharma company, from zero Human resources and onboarding 6 modules · 6 hours Human resources and onboarding: working with European counterparts day to day Human resources and onboarding 5 modules · 5 hours Human resources and onboarding: the ten documents and systems you will touch most Human resources and onboarding 10 modules · 10 hours IT, data and validation: the European essentials in one course IT, data and validation 8 modules · 8 hours IT, data and validation: the first month in a pharma company, from zero IT, data and validation 6 modules · 6 hours IT, data and validation: working with European counterparts day to day IT, data and validation 5 modules · 5 hours IT, data and validation: the ten documents and systems you will touch most IT, data and validation

Nationality and niche combinations

12 modules · 12 hours Selling into Europe as an API and intermediates maker from India India, API and intermediates maker 12 modules · 12 hours Selling into Europe as a contract manufacturer (CDMO / CMO) from India India, Contract manufacturer (CDMO / CMO) 12 modules · 12 hours Selling into Europe as a finished-dose generic company from India India, Finished-dose generic company 12 modules · 12 hours Selling into Europe as a biologics and biosimilars from India India, Biologics and biosimilars 12 modules · 12 hours Selling into Europe as an excipient supplier from India India, Excipient supplier 12 modules · 12 hours Selling into Europe as a packaging and machinery supplier from India India, Packaging and machinery supplier 12 modules · 12 hours Selling into Europe as a nutraceutical and natural products from India India, Nutraceutical and natural products 12 modules · 12 hours Selling into Europe as a trader, distributor, wholesaler from India India, Trader, distributor, wholesaler 12 modules · 12 hours Selling into Europe as a regulatory and QA consultancy from India India, Regulatory and QA consultancy 12 modules · 12 hours Selling into Europe as a CRO and analytical laboratory from India India, CRO and analytical laboratory 12 modules · 12 hours Selling into Europe as a pharma software and AI vendor from India India, Pharma software and AI vendor 12 modules · 12 hours Selling into Europe as a pharma logistics and cold chain from India India, Pharma logistics and cold chain 12 modules · 12 hours Selling into Europe as an API and intermediates maker from China China, API and intermediates maker 12 modules · 12 hours Selling into Europe as a contract manufacturer (CDMO / CMO) from China China, Contract manufacturer (CDMO / CMO) 12 modules · 12 hours Selling into Europe as a finished-dose generic company from China China, Finished-dose generic company 12 modules · 12 hours Selling into Europe as a biologics and biosimilars from China China, Biologics and biosimilars 12 modules · 12 hours Selling into Europe as an excipient supplier from China China, Excipient supplier 12 modules · 12 hours Selling into Europe as a packaging and machinery supplier from China China, Packaging and machinery supplier 12 modules · 12 hours Selling into Europe as a nutraceutical and natural products from China China, Nutraceutical and natural products 12 modules · 12 hours Selling into Europe as a trader, distributor, wholesaler from China China, Trader, distributor, wholesaler 12 modules · 12 hours Selling into Europe as a regulatory and QA consultancy from China China, Regulatory and QA consultancy 12 modules · 12 hours Selling into Europe as a CRO and analytical laboratory from China China, CRO and analytical laboratory 12 modules · 12 hours Selling into Europe as a pharma software and AI vendor from China China, Pharma software and AI vendor 12 modules · 12 hours Selling into Europe as a pharma logistics and cold chain from China China, Pharma logistics and cold chain 12 modules · 12 hours Selling into Europe as an API and intermediates maker from Türkiye Türkiye, API and intermediates maker 12 modules · 12 hours Selling into Europe as a contract manufacturer (CDMO / CMO) from Türkiye Türkiye, Contract manufacturer (CDMO / CMO) 12 modules · 12 hours Selling into Europe as a finished-dose generic company from Türkiye Türkiye, Finished-dose generic company 12 modules · 12 hours Selling into Europe as a biologics and biosimilars from Türkiye Türkiye, Biologics and biosimilars 12 modules · 12 hours Selling into Europe as an excipient supplier from Türkiye Türkiye, Excipient supplier 12 modules · 12 hours Selling into Europe as a packaging and machinery supplier from Türkiye Türkiye, Packaging and machinery supplier 12 modules · 12 hours Selling into Europe as a nutraceutical and natural products from Türkiye Türkiye, Nutraceutical and natural products 12 modules · 12 hours Selling into Europe as a trader, distributor, wholesaler from Türkiye Türkiye, Trader, distributor, wholesaler 12 modules · 12 hours Selling into Europe as a regulatory and QA consultancy from Türkiye Türkiye, Regulatory and QA consultancy 12 modules · 12 hours Selling into Europe as a CRO and analytical laboratory from Türkiye Türkiye, CRO and analytical laboratory 12 modules · 12 hours Selling into Europe as a pharma software and AI vendor from Türkiye Türkiye, Pharma software and AI vendor 12 modules · 12 hours Selling into Europe as a pharma logistics and cold chain from Türkiye Türkiye, Pharma logistics and cold chain 12 modules · 12 hours Selling into Europe as an API and intermediates maker from Korea Korea, API and intermediates maker 12 modules · 12 hours Selling into Europe as a contract manufacturer (CDMO / CMO) from Korea Korea, Contract manufacturer (CDMO / CMO) 12 modules · 12 hours Selling into Europe as a finished-dose generic company from Korea Korea, Finished-dose generic company 12 modules · 12 hours Selling into Europe as a biologics and biosimilars from Korea Korea, Biologics and biosimilars 12 modules · 12 hours Selling into Europe as an excipient supplier from Korea Korea, Excipient supplier 12 modules · 12 hours Selling into Europe as a packaging and machinery supplier from Korea Korea, Packaging and machinery supplier 12 modules · 12 hours Selling into Europe as a nutraceutical and natural products from Korea Korea, Nutraceutical and natural products 12 modules · 12 hours Selling into Europe as a trader, distributor, wholesaler from Korea Korea, Trader, distributor, wholesaler 12 modules · 12 hours Selling into Europe as a regulatory and QA consultancy from Korea Korea, Regulatory and QA consultancy 12 modules · 12 hours Selling into Europe as a CRO and analytical laboratory from Korea Korea, CRO and analytical laboratory 12 modules · 12 hours Selling into Europe as a pharma software and AI vendor from Korea Korea, Pharma software and AI vendor 12 modules · 12 hours Selling into Europe as a pharma logistics and cold chain from Korea Korea, Pharma logistics and cold chain 12 modules · 12 hours Selling into Europe as an API and intermediates maker from Japan Japan, API and intermediates maker 12 modules · 12 hours Selling into Europe as a contract manufacturer (CDMO / CMO) from Japan Japan, Contract manufacturer (CDMO / CMO) 12 modules · 12 hours Selling into Europe as a finished-dose generic company from Japan Japan, Finished-dose generic company 12 modules · 12 hours Selling into Europe as a biologics and biosimilars from Japan Japan, Biologics and biosimilars 12 modules · 12 hours Selling into Europe as an excipient supplier from Japan Japan, Excipient supplier 12 modules · 12 hours Selling into Europe as a packaging and machinery supplier from Japan Japan, Packaging and machinery supplier 12 modules · 12 hours Selling into Europe as a nutraceutical and natural products from Japan Japan, Nutraceutical and natural products 12 modules · 12 hours Selling into Europe as a trader, distributor, wholesaler from Japan Japan, Trader, distributor, wholesaler 12 modules · 12 hours Selling into Europe as a regulatory and QA consultancy from Japan Japan, Regulatory and QA consultancy 12 modules · 12 hours Selling into Europe as a CRO and analytical laboratory from Japan Japan, CRO and analytical laboratory 12 modules · 12 hours Selling into Europe as a pharma software and AI vendor from Japan Japan, Pharma software and AI vendor 12 modules · 12 hours Selling into Europe as a pharma logistics and cold chain from Japan Japan, Pharma logistics and cold chain 12 modules · 12 hours Selling into Europe as an API and intermediates maker from Taiwan Taiwan, API and intermediates maker 12 modules · 12 hours Selling into Europe as a contract manufacturer (CDMO / CMO) from Taiwan Taiwan, Contract manufacturer (CDMO / CMO) 12 modules · 12 hours Selling into Europe as a finished-dose generic company from Taiwan Taiwan, Finished-dose generic company 12 modules · 12 hours Selling into Europe as a biologics and biosimilars from Taiwan Taiwan, Biologics and biosimilars 12 modules · 12 hours Selling into Europe as an excipient supplier from Taiwan Taiwan, Excipient supplier 12 modules · 12 hours Selling into Europe as a packaging and machinery supplier from Taiwan Taiwan, Packaging and machinery supplier 12 modules · 12 hours Selling into Europe as a nutraceutical and natural products from Taiwan Taiwan, Nutraceutical and natural products 12 modules · 12 hours Selling into Europe as a trader, distributor, wholesaler from Taiwan Taiwan, Trader, distributor, wholesaler 12 modules · 12 hours Selling into Europe as a regulatory and QA consultancy from Taiwan Taiwan, Regulatory and QA consultancy 12 modules · 12 hours Selling into Europe as a CRO and analytical laboratory from Taiwan Taiwan, CRO and analytical laboratory 12 modules · 12 hours Selling into Europe as a pharma software and AI vendor from Taiwan Taiwan, Pharma software and AI vendor 12 modules · 12 hours Selling into Europe as a pharma logistics and cold chain from Taiwan Taiwan, Pharma logistics and cold chain 12 modules · 12 hours Selling into Europe as an API and intermediates maker from Egypt, Gulf and MENA Egypt, Gulf and MENA, API and intermediates maker 12 modules · 12 hours Selling into Europe as a contract manufacturer (CDMO / CMO) from Egypt, Gulf and MENA Egypt, Gulf and MENA, Contract manufacturer (CDMO / CMO) 12 modules · 12 hours Selling into Europe as a finished-dose generic company from Egypt, Gulf and MENA Egypt, Gulf and MENA, Finished-dose generic company 12 modules · 12 hours Selling into Europe as a biologics and biosimilars from Egypt, Gulf and MENA Egypt, Gulf and MENA, Biologics and biosimilars 12 modules · 12 hours Selling into Europe as an excipient supplier from Egypt, Gulf and MENA Egypt, Gulf and MENA, Excipient supplier 12 modules · 12 hours Selling into Europe as a packaging and machinery supplier from Egypt, Gulf and MENA Egypt, Gulf and MENA, Packaging and machinery supplier 12 modules · 12 hours Selling into Europe as a nutraceutical and natural products from Egypt, Gulf and MENA Egypt, Gulf and MENA, Nutraceutical and natural products 12 modules · 12 hours Selling into Europe as a trader, distributor, wholesaler from Egypt, Gulf and MENA Egypt, Gulf and MENA, Trader, distributor, wholesaler 12 modules · 12 hours Selling into Europe as a regulatory and QA consultancy from Egypt, Gulf and MENA Egypt, Gulf and MENA, Regulatory and QA consultancy 12 modules · 12 hours Selling into Europe as a CRO and analytical laboratory from Egypt, Gulf and MENA Egypt, Gulf and MENA, CRO and analytical laboratory 12 modules · 12 hours Selling into Europe as a pharma software and AI vendor from Egypt, Gulf and MENA Egypt, Gulf and MENA, Pharma software and AI vendor 12 modules · 12 hours Selling into Europe as a pharma logistics and cold chain from Egypt, Gulf and MENA Egypt, Gulf and MENA, Pharma logistics and cold chain 12 modules · 12 hours Selling into Europe as an API and intermediates maker from Brazil and Latin America Brazil and Latin America, API and intermediates maker 12 modules · 12 hours Selling into Europe as a contract manufacturer (CDMO / CMO) from Brazil and Latin America Brazil and Latin America, Contract manufacturer (CDMO / CMO) 12 modules · 12 hours Selling into Europe as a finished-dose generic company from Brazil and Latin America Brazil and Latin America, Finished-dose generic company 12 modules · 12 hours Selling into Europe as a biologics and biosimilars from Brazil and Latin America Brazil and Latin America, Biologics and biosimilars 12 modules · 12 hours Selling into Europe as an excipient supplier from Brazil and Latin America Brazil and Latin America, Excipient supplier 12 modules · 12 hours Selling into Europe as a packaging and machinery supplier from Brazil and Latin America Brazil and Latin America, Packaging and machinery supplier 12 modules · 12 hours Selling into Europe as a nutraceutical and natural products from Brazil and Latin America Brazil and Latin America, Nutraceutical and natural products 12 modules · 12 hours Selling into Europe as a trader, distributor, wholesaler from Brazil and Latin America Brazil and Latin America, Trader, distributor, wholesaler 12 modules · 12 hours Selling into Europe as a regulatory and QA consultancy from Brazil and Latin America Brazil and Latin America, Regulatory and QA consultancy 12 modules · 12 hours Selling into Europe as a CRO and analytical laboratory from Brazil and Latin America Brazil and Latin America, CRO and analytical laboratory 12 modules · 12 hours Selling into Europe as a pharma software and AI vendor from Brazil and Latin America Brazil and Latin America, Pharma software and AI vendor 12 modules · 12 hours Selling into Europe as a pharma logistics and cold chain from Brazil and Latin America Brazil and Latin America, Pharma logistics and cold chain 12 modules · 12 hours Selling into Europe as an API and intermediates maker from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, API and intermediates maker 12 modules · 12 hours Selling into Europe as a contract manufacturer (CDMO / CMO) from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, Contract manufacturer (CDMO / CMO) 12 modules · 12 hours Selling into Europe as a finished-dose generic company from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, Finished-dose generic company 12 modules · 12 hours Selling into Europe as a biologics and biosimilars from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, Biologics and biosimilars 12 modules · 12 hours Selling into Europe as an excipient supplier from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, Excipient supplier 12 modules · 12 hours Selling into Europe as a packaging and machinery supplier from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, Packaging and machinery supplier 12 modules · 12 hours Selling into Europe as a nutraceutical and natural products from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, Nutraceutical and natural products 12 modules · 12 hours Selling into Europe as a trader, distributor, wholesaler from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, Trader, distributor, wholesaler 12 modules · 12 hours Selling into Europe as a regulatory and QA consultancy from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, Regulatory and QA consultancy 12 modules · 12 hours Selling into Europe as a CRO and analytical laboratory from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, CRO and analytical laboratory 12 modules · 12 hours Selling into Europe as a pharma software and AI vendor from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, Pharma software and AI vendor 12 modules · 12 hours Selling into Europe as a pharma logistics and cold chain from Pakistan, Bangladesh and Vietnam Pakistan, Bangladesh and Vietnam, Pharma logistics and cold chain 12 modules · 12 hours Selling into Europe as an API and intermediates maker from United States United States, API and intermediates maker 12 modules · 12 hours Selling into Europe as a contract manufacturer (CDMO / CMO) from United States United States, Contract manufacturer (CDMO / CMO) 12 modules · 12 hours Selling into Europe as a finished-dose generic company from United States United States, Finished-dose generic company 12 modules · 12 hours Selling into Europe as a biologics and biosimilars from United States United States, Biologics and biosimilars 12 modules · 12 hours Selling into Europe as an excipient supplier from United States United States, Excipient supplier 12 modules · 12 hours Selling into Europe as a packaging and machinery supplier from United States United States, Packaging and machinery supplier 12 modules · 12 hours Selling into Europe as a nutraceutical and natural products from United States United States, Nutraceutical and natural products 12 modules · 12 hours Selling into Europe as a trader, distributor, wholesaler from United States United States, Trader, distributor, wholesaler 12 modules · 12 hours Selling into Europe as a regulatory and QA consultancy from United States United States, Regulatory and QA consultancy 12 modules · 12 hours Selling into Europe as a CRO and analytical laboratory from United States United States, CRO and analytical laboratory 12 modules · 12 hours Selling into Europe as a pharma software and AI vendor from United States United States, Pharma software and AI vendor 12 modules · 12 hours Selling into Europe as a pharma logistics and cold chain from United States United States, Pharma logistics and cold chain

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