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Selling into Europe as a biologics and biosimilars from the United States
Ensure your European biologics market entry avoids costly regulatory missteps and delays.
The moment it goes wrong
Your biologics product launch in Europe faces a sudden delay because a crucial dossier detail was overlooked. This mistake can halt market access for months, resulting in millions in lost revenue and damaging investor confidence. The cost of a single manufacturing batch held at customs can be catastrophic.
What changes after this course
Your team will confidently explain European regulatory requirements and market access strategies. You will hold a comprehensive training record, demonstrating your team's readiness for European expansion, along with individual completion certificates.
How long it takes, by who is listening
Nobody spends a day in a classroom. Every module exists in three lengths; a person takes the length their role needs, and every length ends with the same recorded questionnaire, so the training record is complete either way.
| Who takes this course | Length | Total time |
|---|---|---|
| Owner, CEO and board | Briefing | 2 h |
| Business development and export sales | Briefing | 2 h |
| Regulatory affairs | Standard | 5 h |
| Quality assurance and Qualified Person | Standard | 5 h |
What is in the course, module by module
12 modules. Under each title are the three things the listener can do afterwards; the audio itself runs 10 to 50 minutes depending on the length chosen. Each module ends with a multiple-choice questionnaire whose result is recorded per person for your auditor. Your human-resources or quality manager decides what counts as passed and when a level is retaken.
1Grasp the European Biologics Market Landscape
- The European Medicines Agency (EMA) oversees centralized marketing authorization across the European Union.
- Understand the diverse national healthcare systems within Europe impacting market entry.
- Recognize the strategic importance of early engagement with key European stakeholders.
2Identify Key European Regulatory Frameworks
- The European Union's Directive 2001/83/EC sets the framework for medicinal products for human use.
- Grasp how the centralised procedure through the EMA offers a single authorization for all European Union member states.
- Distinguish between the roles of the EMA and national competent authorities in product approval.
3Prepare Your Marketing Authorization Application
- The Common Technical Document (CTD) format is mandatory for all Marketing Authorization Applications (MAA) in the European Union.
- Understand the specific content requirements for Module 3 (Quality) for biologics and biosimilars.
- A missing or incorrect declaration of manufacturing sites can cause significant delays in MAA approval.
4Master Biologics and Biosimilars Specifics
- The concept of biosimilarity is established through extensive comparability exercises, not identicality.
- Understand the EMA's guideline on similar biological medicinal products (EMA/CHMP/BMWP/403543/2010 rev. 1).
- A failure to demonstrate adequate comparability data can lead to rejection of a biosimilar application.
5Implement Effective Pharmacovigilance Systems
- The EU Good Pharmacovigilance Practices (GVP) modules outline requirements for drug safety monitoring.
- Your company must appoint a Qualified Person for Pharmacovigilance (QPPV) residing in the European Union.
- A lapse in reporting adverse events within required timelines can result in significant regulatory fines.
6Understand European Pricing and Reimbursement
- Pricing and reimbursement decisions are primarily made at the national or regional level in Europe, not centrally.
- Health Technology Assessment (HTA) bodies like NICE (UK) or IQWiG (Germany) evaluate clinical and economic value.
- Ignoring local HTA requirements can lead to poor reimbursement decisions and limited market access.
7Develop European Market Access Strategies
- Formulate a market access strategy that accounts for diverse national pricing and reimbursement landscapes.
- Understand the importance of early engagement with payers and HTA bodies before product launch.
- A lack of clear value proposition tailored to local needs can significantly reduce market uptake.
8Manage European Supply Chain and Customs
- Compliance with EU Good Distribution Practice (GDP) guidelines is essential for all supply chain activities.
- Correct customs declarations, including Harmonized System (HS) codes, prevent shipment delays at borders.
- An improperly labeled biologics shipment held at a European customs point can incur daily storage fees and spoilage.
9Address Commercial and Legal Considerations
- Understand the implications of parallel trade and intellectual property protection within the European Union.
- Compliance with the General Data Protection Regulation (GDPR) is mandatory for all patient data handling.
- Failure to protect intellectual property rights can result in significant market share erosion.
10Plan for Post-Launch Activities and Variations
- All changes to an approved product require a variation application to the European Medicines Agency or national authorities.
- Implement post-marketing surveillance programs as required for biologics and biosimilars.
- An unapproved manufacturing change can lead to product recalls and regulatory sanctions.
11Prepare for Regulatory Compliance and Audits
- The European Medicines Agency conducts Good Manufacturing Practice (GMP) inspections of manufacturing sites.
- Understand the audit scope for pharmacovigilance and quality management systems by European authorities.
- Poor audit findings can result in import bans or revocation of marketing authorizations.
12Strategize for Future European Market Evolution
- Anticipate upcoming changes in European Union regulatory guidelines for advanced therapy medicinal products (ATMPs).
- Consider the impact of health data initiatives and digital health on future market access strategies.
- Failing to adapt to evolving regulatory expectations can leave your product at a competitive disadvantage.
Price for this title
One licence, 12 modules in all three lengths, included in every purchase, every employee of the legal entity, 12 months. Pick your company size.
Cheaper as part of a track pack or company library. Delivered within 72 hours of payment or the course is free.
Custom course or custom pricing? A course built on your own procedures and products, a mixed bundle, several legal entities, or a budget that does not fit a table: tell us on WhatsApp and you have a written quote the same day.
Ask about custom courses and custom pricingWho this is for
Roles: Owner, CEO and board, Business development and export sales, Regulatory affairs, Quality assurance and Qualified Person,
Businesses: Biologics and biosimilars,
Countries: United States
What you receive
- Audio modules in all three lengths, included in every purchase. The briefing for the board and the sales floor, the standard run for regulatory and quality, the expanded walk-through for the bench. One price buys all three; each person takes the length their role needs. Listen on the commute, at the bench, in the car.
- Made to be listened to. A narrator with character, a story in every module and real examples from the buyer's side of the table. Not a read-out of the guideline that puts the room to sleep.
- Companion workbook. Exercises and checklists per module, ready to file.
- Full transcript. Searchable, printable, quotable in your procedures.
- Source for every fact. Each statement links to its guideline, regulation or paper, so an auditor can check it.
- Certificate per learner. Name, course, hours, guideline version, date.
- Auditable training record. Per-person export for your quality file, the document inspectors ask for under EU GMP Chapter 2.
English first. Other languages are available in test mode on request.
Request a free sample module