Course overview

Combination Products
for Pharmaceuticals

The MDR has introduced new requirements for medicinal products with an integral device. Because we understand that new requirements can be complex, we've devised a course to help you navigate the complicated regulatory landscape of the challenges associated with drug-device combination products.

This 6-hour course will address the European regulatory requirements for combination products, 
help you define the regulatory route for your product and offer practical guidance on Article 117 requirements. By the end of this training, you will understand the Notified Body process and get clarity on expectations for technical documentation. You will also be introduced to the MDR Annex I GSPRs and receive an update on available guidance.

This course is delivered virtually using Zoom and is fully interactive, offering you the chance to take part in group activities, participate in polls and download course materials.

Format 

Virtual
Instructor-Led

Date / Time

Select your date below 

Price

€585

Duration

6 Hours

Time

1pm - 4pm

Time Zone

GMT

Course Information

Dates & Prices
Course Syllabus 
What's Included
Technology Requirements
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Training Dates

We're currently finalising our 2024 course calendar. Register your interest below to be the first to receive new dates! 

Training Times

1 pm - 4 pm GMT
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Discounts 

Group booking discounts are available as followed:

• 3 – 5 attendees receive 15% discount
• 6 or more attendees receive 20% discount

Email our team at [email protected] and one of the team will provide you with your unique discount code or invoice. 

More than 8 attendees?

If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

What Is Included?

▪    Direct, live access to an expert trainer
▪    Access to the Meddev Solutions Training Portal
▪    Fully Interactive Course - Polls, quizzes and breakout sessions 
▪    Downloadable Resources 
▪    CoE Accredited Certificate of Completion
▪    Knowledge Checks
▪    Full Tutor Support 

Course Agenda

This training course will explore the following topics:

Day 1
  • Introductions
  • Background and Introduction to MDR Article 117
  • MDR 2017/745 Introduction to the CE Certification process and key concepts
  • Key Stakeholders in Article 117 process – Role and Responsibilities
  • Medical device & medicinal product borderline area
  • Classification of a medical device and key definitions

Day 2
  • Recap
  • MDR Annex I General Safety & Performance Requirements (GSPRs)
  • Article 117 Options for MAA submissions
  • Documentation required to facilitate NB Opinion process
  • Management of Changes and impact on NB Opinion

Learning Objectives

  • Be able to determine if Article 117 is applicable to your product
  • Appreciate the requirements of MDR Article 117 and options available to support your MAA
  • Gain a basic appreciation of the MDR content and CE Certification process for a medical device
  • Have a knowledge of the stakeholders involved in the process
  • Be familiar with the documentation and data needed to demonstrate conformity with the relevant GSPRS for a medical device
  • Be able to help and guide your organization in the development and preparation of documentation for medicinal products with an integral medical device

Who Should Attend? 

This course is recommended for anyone in the pharmaceutical industry who is interested in pharmaceutical products incorporating a device or
delivery system, and who need to understand the impacts of A117 on the Marketing Authorization Application.

  • Development Scientists
  • Regulatory personnel

Technology Requirements

Operating system
Windows requirements: Windows 7 or later
Mac requirements: Mac OS X Yosemite 10.10 or later
Linux requirements: 64-bit, Ubuntu 14.04+, Debian 8+,openSUSE 13.3+ or Fedora Linux 24+

Processor
Windows requirements: Intel Pentium 4 or later
Mac requirements: Intel
Linux requirements: Intel Pentium 4 or later

Internet connection
Required

Zoom

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.

Get your training agenda

Simply fill in the form to access your training agenda now.

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Meet your instructor

Theresa Jeary

Trainer & Consultant

Theresa holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person. She has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments.

In addition to her product development and global regulatory expertise, Theresa has over 12 years' Notified Body experience, first at BSI as a technical expert for devices with ancillary medicinal substance and borderline classifications moving then to LRQA where she held the role of Head of Notified Body for several years.
More recently Theresa has worked as a consultant to the medtech sector assisting Manufacturers in their product development and supporting them in navigating their legal requirements and changes to the Medical Device Regulations.

Theresa is a regular presenter on combination products and Article 117 and regularly contributes to various scientific publications and regulatory guidance and has extensive experience of interacting with EU Competent Authorities.  
Rod Beuzeval

Training for your team,
your way

We understand that every company is different and face unique challenges everyday. At Meddev, we can tailor any of our courses around your organisation’s specific needs and products. 

Bespoke learning experience

Develop your course with a leading subject matter expert to meet the specific needs of your organisation

Maximise your budget

Cut unnecessary costs and allocate your budget on what matters most

Track employee progress

Keep track of your employees’ progression in your own workspace

Get your training agenda

Frequently asked questions

When will I receive the course confirmation details? 

Once your booking has been placed and confirmed, you will receive an email which contains your course overview, login details, course agenda and payment receipts. You can begin your training immediately!

What is included in the course?

▪ Direct, live access to an expert trainer
▪ Access to the Meddev Solutions Training Portal
▪ Fully Interactive Course - Polls, quizzes and breakout sessions
▪ Downloadable Resources
▪ CoE Accredited Certificate of Completion
▪ Knowledge Checks
▪ Full Tutor Support 

Is this course live?

Yes! This course is completely live with a Centre of Excellence-approved industry expert. You can ask questions throughout the course as if you were in a real classroom. 

What time is this course?

We run this course from 1 pm - 4 pm GMT. If you can't make the live sessions, don't worry. We will record them, so you can catch up on anything you've missed!

Do I get a course certificate?

On successful completion of the course, you will receive a certificate of completion that can be used to demonstrate your knowledge to your employers and Notified Bodies. 

What payment methods do you accept?

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, and you require a PO, please email our team at [email protected]

Do you offer group booking discounts?

Absolutely! 3 – 5 attendees receive a 15% discount and 6 or more attendees receive a 20% discount. If there are more than 8 people from your organization that would like to take this course, consider arranging an in-house training. The price can often work out cheaper, and the course can be customized to your exact needs.

Can I transfer my place to another colleague?

Yes of course. If you can no longer attend the course, you can transfer your place at no additional cost.

What application do you use for the training?

We use Zoom for our virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
Ready to get started?