Drug-Device Combination Products: Quality & Regulatory Requirements
Drug-Device Combination Products: Quality & Regulatory Requirements

Course Description

The challenges associated with drug-device combination products are complicated as they must be registered either as pharmaceutical or medical device products. This course will help you navigate this complicated regulatory landscape. You will return with an understanding of the complex regulatory landscape as it applies to your drug/device combination, including risk management, clinical considerations, and design control.
  • Key definitions
  • Regulatory update & pathway (FDA & EMA)
  • Notified Body (NB) Review Process
  • General Safety & Performance Requirements (GSPR)
  • Labeling
  • Quality management systems
  • Post-market surveillance
  • Understand the regulatory requirements for drug-device, device-drug combinations
  • Gain an understanding of the roles of Competent Authorities and Notified Bodies
  • Examine best practices for working with medical device suppliers and manufacturers
  • Engage new stakeholders and establish new processes
  • Establish a control strategy to deliver safe and efficacious products
  • Understand design control expectations

Drug-Device Combination Products: Quality & Regulatory Requirements

12 -14 November 2024, Live Online Training
€1.850,00
James Pink

James Pink has over 20 years of experience in medical devices including 10 years as a lead auditor for European Notified Body. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

START TIMES

9:00 AM Vienna time

8:00 AM London time

3:00 AM New York time

12:00 AM Los Angeles time

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Course Description

The challenges associated with drug-device combination products are complicated as they must be registered either as pharmaceutical or medical device products. This course will help you navigate this complicated regulatory landscape. You will return with an understanding of the complex regulatory landscape as it applies to your drug/device combination, including risk management, clinical considerations, and design control.
  • Key definitions
  • Regulatory update & pathway (FDA & EMA)
  • Notified Body (NB) Review Process
  • General Safety & Performance Requirements (GSPR)
  • Labeling
  • Quality management systems
  • Post-market surveillance
  • Understand the regulatory requirements for drug-device, device-drug combinations
  • Gain an understanding of the roles of Competent Authorities and Notified Bodies
  • Examine best practices for working with medical device suppliers and manufacturers
  • Engage new stakeholders and establish new processes
  • Establish a control strategy to deliver safe and efficacious products
  • Understand design control expectations

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Drug-Device Combination Products: Quality & Regulatory Requirements

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

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