Trainings

BioReg offers a wide range of training to instill competence and awareness within your organization.
We can provide online or on-site training sessions (personal or group) as required by your Company on different subjects related to EU Regulations or Quality Management Systems.

Some of the standard trainings include:

• Introduction to the EU MDR / EU IVDR
• Risk Management
• Post–Market Surveillance (PMS), including Vigilance and Post–Market Clinical Follow Up (PMCF)
• PRRC Course: Bringing your PRRC up to speed with the EU Regulations and their responsibilities
• Importer and Distributor Obligations
• Internal Audits
• Supplier Control, including supplier audits
• CAPA Management
• ISO 13485: 2016 masterclass
• Standardization in medicine and pharmacy
• Basics of management in medicine and pharmacy
• Corporate social responsibility (CSR) in medicine and pharmacy
• Pharmaceutical market sizing and related research

• Market Access – basics, significance, and process
• About patent, its design, and patent registration
• What is a trademark
• What are the benefits of IP protections
• How does the patent process work – how to speed it up
• Patent searching
• What steps to avoid to not inadvertently bar yourself from a patent
• Licensing
• Purchasing/selling patent assets
• Infringement & Disputes

After completion of the training, written confirmation will be sent as evidence of your ongoing competence. This notification could be used e.g., as annual ISO 13485 and EU-MDR training for your organization.

For more information, please contact the BioReg team.