NEXT DATE:
Oct 10-11
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A 2-day practical & interactive training:

Challenges in Drug/Device
Combination Products

Over two days, you will work with our experienced trainer to understand the medical device world as it applies to your drug/device combination, including risk management, clinical considerations and design control. The course will also feature a session on collaborating with partners in the device world to improve outcomes for your products.

Agenda

Drug/device combination products present unique challenges. Under EU law, combination products must be registered as either pharmaceutical products or medical devices. For drug/device combinations, significant problems can arise in understanding an unfamiliar regulatory environment, product design, corporate collaborations and much else. This essential course provides useful insights into requirements for devices to improve your understanding of additional aspects to be incorporated into your dossier.

DAY 1
9am - 5pm

The regulatory environment for combination products
  • Definition of a Combination Product
  • Categorisation of your product – what is its intended primary mode of action?
  • How are combination products regulated in the US and EU?
  • Reviewing the regulations for drug/device products – FDA CFR 21 and (EC) No 726/2004

Device regulations and requirements
  • Overview of the current regulatory framework for medical devices in the EU
  • Roles of Competent Authorities and Notified Bodies
  • Upcoming changes with the new MDR
  • CE marking for separate devices in drug/device products

Labelling
  • Brief overview of medical device and pharmaceutical labelling regulations
  • How are labelling concerns different for combination products?
  • Incorporating instructions for use in your patient leaflet

Strategies for pharma/medtech collaboration
  • Consider communication challenges between devices and pharma
  • Examine best practices for working with suppliers/manufacturers from the medical device world
  • Collaboration with a variety of partners
DAY 2
9am - 5pm

Clinical studies
  • Understand recent changes in clinical requirements for pharmaceuticals and medical devices
    -) The Clinical Trials Regulation
    -) Clinical evidence requirements of the MDR
  • What should you take into account when designing a trial for a combination product?
  • Strategy for adverse events – is it connected to the drug or device?

Risk management
  • What is risk management?
  • Consider how risk management for a combination product may differ from a pharmaceutical product – how may materials pose risk?
  • Examine ISO 14971
  • How to integrate a risk management approach

Design control
  • What are the design expectations when developing a device – examine EU and US perspective
  • Design inputs – delineating between user and stakeholder needs and technical requirements
  • Integrating medical device development activities within a pharmaceutical company
  • Examining human factors
  • Reviewing design validation

    • Post-market surveillance and vigilance
  • Understand the PMS requirements for medical devices
  • Consider how PMS requirements would need to be incorporated into pharmacovigilance requirements for your combination product
    		•
    Delegates will engage in practical exercises throughout the two days to reinforce learning objectives.
    This course is a cooperation with PTI - a global interactive training partner committed to the personal progression of aspiring life science professionals.
    If booked by Sept 10 2018:
    £ 1.495 ,-
    If booked after Sept 10 2018:
    £ 1.595 ,-
    Prices excl. 20% VAT
    Book this training
    Register online here
    For further questions please contact us: +43 (0)1 890 57 14
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