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LIVE Online Academy - 4 Sessions

Learn the key factors of successful drug/device combination products to ensure a more efficient approval process

Course Overview

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.

On this course, 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. There will also be additional time for delegates to discuss the implications of Brexit on this subject matter. 

Live Online Academies

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.

Over 4 days students will learn through:

  • Live interactive bitesize sessions
  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

What will you learn?


Key Definitions
Key Definitions

Comprehend how combination products are defined and classified

Regulatory Landscape
Regulatory Landscape

Understand the regulations for drug/device combination product

Competent Authorities
Competent Authorities

Gain an understanding of the roles of Competent Authorities and Notified Bodies


CE Marking
CE Marking

Learn about CE marking for separate devices in drug/device combinations

Labelling Requirements
Labelling Requirements

Compare labelling requirements for medical devices and pharmaceutical products to consider how labelling concerns may be different for combination products

Medical Device Manufacturers
Medical Device Manufacturers

Examine best practices for working with medical device suppliers and manufacturers


Clinical Trials
Clinical Trials

Consider special requirements for clinical trials for combination products

Risk Management
Risk Management

Discuss how to integrate a risk management approach

Control Expectation
Control Expectation

Understand design control expectations


Pharmacovigilance
Pharmacovigilance

Consider Pharmacovigilance requirements

Who is this course for?

This course is designed for professionals from the pharmaceutical industry who wish to gain a greater understanding of drug/device combination products, including:

  • Regulatory Affairs
  • Quality Assurance
  • CMC
  • R&D
  • Project managers
  • Consultants


CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

Delegates of our live online academies said...

94%
would attend another live online academy
97%
found the course beneficial to their day to day role
97%
would recommend the course to others