Individual
location
Flexible
date

A 2-day practical & interactive training:

Combination products

Equip your professionals with a complete practical understanding of the regulatory framework of combination products in the EU and US. Offer them an insight into the complex regulatory environment of combination products. All that with one training which is suitable for pharmaceutical, biotechnological and medical device manufacturers.
Combination products
The CPD Certification Service
Continuing Professional Development (CPD) combines different methodologies to learning, such as training workshops, conferences and events, e-learning programs, best practice techniques and ideas sharing, all focused for an individual to improve and have effective professional development.
For more information visit the CPD website

Agenda

DAY 1
9am - 5pm
Overview of regulations in the EU and US
  • Medical device regulations EU
  • Medical device regulations US
  • Combination products regulation in the EU and US
Risk management
  • Medical device risk management
  • Standards
  • The Risk Management Process: Risk management plan, risk analysis, evaluation and control
  • Residual risk
Vendor management
  • Vendor qualification
  • Audits
  • Quality agreements
DAY 2
9am - 5pm
Labelling requirements
  • Examining the labelling requirements
  • Identifying each of the labelling requirements
Dealing with post-approval changes
  • Gaining a clearer understanding of when variations should be submitted
  • Clarifying the variability of the requirements for different product types
  • Timelines and fees
  • The variation approval process
Documentation (CTD/STED for product submissions)
  • CE marked devices
  • Non CE marked devices
  • Combination is a drug – CTD requirements
  • Combination is a device – STED requirements
Book this training

Please contact us to book this training:

Contact us via web formular

+43 (0)1 890 57 14


* Terms and conditions
  • The price includes: Training, electronic workbooks, catering during the courses, certificates
  • Cancellation 30 days prior to the start of the training: No fees will be charged
  • Cancellation 29 - 7 days prior to the start of the training: 50 % of the fees will be charged
  • Cancellation 6 days or less prior to the start of the training: 100 % of the fees will be charged