Drug-Device combination products in EU and US

Struttura del corso

09:30– 13:00 COURSE SESSION DAY 1
09:30– 13:00 COURSE SESSION DAY 2

Programma

Day 1

9:30 Introduction & speed networking

9:40 Combination Products in EU

• Definitions in EU
  • Combination Product
  • Medicinal Product
  • Medical Device
• Legal framework
  • Medicinal product and medical device legislations
  • Revision to EU Medical Device Regulation (MDR)
  • Regulatory similarities and differences
• Borderline classification in EU: Medical Device or Medicinal product?
  • The importance of classification & its implication
  • Decision Making on the Borderline

Q&A time

10:20 EU Market access for Drug Device Combination Products (DDCs)

• Single integral non-reusable DDCs
• Non-integral Combination Products (kit)
• Data requirements
• Labelling requirements
• Guidance documents

Q&A time

11:25 Break

11:45 Combination Products in US

• Combination Product Definition
• History and Legal Framework
• Borderline Products
• Types of Combination Product (Definitions)
• Primary Mode of Action and FDA’s Assignment Algorithm
• Jurisdiction and Designation Process for Combination Products

Q&A time

13:00 Closure of day one

DAY 2

9:30 EU market access for Device Drug Combination Products

• EU MDR Classification and applicable rule(s)
• Notified Body’s role and obligations
• What is CE Marking?
• CE certification process at a glance
• Documentation requirements at top level

Q&A time

 10:15 EU MDR key changes and its Impact on Drug Device Combination Products 

• Impact on combination products regulated as medicinal product
• Article 117 and Notified Body Opinion report (NBOp)
• Notified Body selection and Interaction
• Documentation requirements
• Life Cycle management: New or updated NBOp?
  • Team-NB position
  • Industry perspective

Q&A time

11:00 Break

11:20 US market access for Combination Products

• FDA’s approach to Combination Products
• Submissions and Regulatory Pathways
• Current Good Manufacturing Practice (cGMP) Requirements
• Strategies for Development of Combination Products

Q&A time

12:30 Conclusion 

12:40 Final Questions session

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.