NEXT DATE:
June 25-26
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A 2-day practical & interactive training:

Combination products

Combination products are especially challenging to register and maintain since they consist of two or more regulated components covered by different and usually independent sets of regulations in both the EU and US and various other regions. Delegates working in this area must keep abreast of current and new legislation in this complex area to ensure a good regulatory strategy and compliance of their products.
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

Overview

  • A thorough understanding of the complexities involved
  • All relevant regulations and guidelines
  • Real life examples of how to register and maintain various types of combinations
  • Interfaces: Change Management and LCM
  • Compliant safety reporting for combination products
  • Documentation requirements and interfacing

Who will benefit

  • Regulatory Affairs
  • Medical Officers
  • Clinical Trial Managers

Agenda

DAY 1
9am - 5pm
A high level overview to Combination Products
  • Including an interactive group session reviewing individual expectations
Introduction to Drug/Device Regulations
  • During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities. Regulatory Requirements for: US and EU
CE Marking, 510 K and PMAs general Overview
  • US and EU
  • Life Cycle Management
    • Interfaces: Change Management
    • CTA applications
    • Annual reporting
CASE STUDY 1
  • a walkthrough of expected outcomes for all case study exercises
  • Wrap up of day 1 & Q&A's
DAY 2
9am - 5pm
Overview Combination product Regulation and CTD dossier requirments
  • EU and US (A comparative review)
Clarifying the regulatory requirements of combination products and addressing life-cycle management
  • Examining the regulatory requirements for drug device combinations in the case of a drug and a device and for integral products
  • Annual reports
  • Case studies
CASE STUDY 2
Compliant safety reporting for combination products
  • Taking into account your product's combined components when addressing adverse event reporting
CASE STUDY 3
Wrap up of day 2
  • Final Q&A & Summary of 'working smart' with Combination Products
This training has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
1 attendee: $ 1,495.00
5 attendees: $ 4,485.00 $ 7,475.00 You Save: $ 2,990.00 (40%)
10 attendees: $ 8,222.00 $ 14,950.00 You Save: $ 6,728.00 (45%)
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