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This seminar provides Professionals working in this area with A thorough understanding of the complexities involved All the relevant regulations and guidelines Real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing Why you should attend : 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. Areas Covered in the Session: Documentation requirements and interfacing Documentation requirements for combination products EU Documentation requirements for combination products US Interfacing, development, quality, regulatory Managing third parties and document control.

Course Audience:
  • Regulatory Affairs
  • Medical Officers
  • Clinical Trial Managers

Day 1 Schedule Lecture 1: A high level overview to Combination Products Including an interactive group session reviewing individual expectations Lecture 2: 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 Lecture 3: CE Marking, 510 K and PMAs general Overview US and EU Life Cycle Management Interfaces: Change Management CTA applications Annual reporting Lecture 4: CASE STUDY 1 - Including a walkthrough of expected outcomes for all case study exercises Wrap up of day 1 & Q&A's Day 2 Schedule Lecture 1: Overview Combination product Regulation and CTD dossier requirments: EU and US (A comparative review) Lecture 2: 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 Lecture 3: CASE STUDY 2 Lecture 4: Compliant safety reporting for combination products Taking into account your product's combined components when addressing adverse event reporting Documentation requirements and interfacing Documentation requirements for combination products EU Documentation requirements for combination products US Interfacing, development, quality, regulatory Managing third parties and document control. CASE STUDY 3 Wrap up of day 2 Final Q&A & Summary of 'working smart' with Combination Products
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HIPAA Privacy, Security and Breach Notification Compliance: Understanding the Requirements, Preventing Incidents, Surviving Audits, and Avoiding Penalties
  • Course ID:
    261612
  • Duration:
    2 days
  • Price:
    $895
  • Date:
    Thursday 11/30/2017
  • Time:
    9:00 am to 5:00 pm
  • Location:
    Chicago
    2930 S River Rd, Des Plaines
    Chicago, IL 60018