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Development of Combination Products: Critical Interactions Training Course

Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.

7-8 Nov 2022

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Details

What this course is about

Drug/device and device/drug combination products are becoming increasingly important in the medical industry. The development and manufacture of these products raises a number of complex issues and the quality and regulatory aspects are challenging. This interactive seminar will clarify the EU and US approach to drug/device and device/drug combination products, address the requirements for the device technical file/design file, explain the biological and synthetic drug regulations and look at the registration procedures for these products.

The programme will cover the regulatory strategy to adopt and the relevant aspects of GMP and quality processes, including the data expectations for the CTD. It will also review the key relationships between quality, regulatory, R&D and production. Delegates will find this a comprehensive overview of the requirements for these products and will have an opportunity to discuss the complexities with an expert in this field.

Benefits of attending:

  • Clarify the definitions for drug/device and device/drug combination products in the EU and USA
  • Consider the requirements for the device technical file/design file
  • Comply with the biological and synthetic drug regulations
  • Understand the registration procedures for devices and medicines in the EU and USA
  • Determine the data required for the Common Technical Document (CTD)
  • Consider the regulatory strategy depending on your product
  • Gain practical advice on how to apply the ISO standards

Who should attend

  • All development, regulatory and quality personnel involved in the development of combination products (drug/device and device/drug products)
  • Pharmacovigilance/vigilance personnel
  • Device experts looking to expand their knowledge to medicines and vice-versa

Programme

Defining a drug/device and device/drug product

  • EU approach
  • US approach

Regulatory procedures for drug/device and device/drug products

  • EU procedures
  • US and Office of Combination Products

Understanding devices

  • Medical Device Regulation – EU
  • CE marking and Notified Body interactions
  • CDRH definitions – US – 510(k) and PMA
  • Labelling
  • Vigilance requirements

Device technical file/design file

  • What is required
  • Structure
  • Bench testing
  • Potential clinical requirements

Workshop: Technical file/design file

Understanding the biological and synthetic drug regulations

  • EU/US definition of medicinal product
  • Labelling
  • Pharmacovigilance
  • Quality requirements

Registration procedures

  • EU approach
  • US approach

GMP and ISO standards

  • Practical application
  • Interpretation of the standards

The CTD

  • Where to put data
  • Data expectations
  • Applying QbD (quality by design)

Workshop: CTD requirements – tracking critical documents

Key considerations for the regulatory strategy

  • Deciding which regulatory route to take
  • Device and product registrations
  • Combination-only registrations
  • Desired labelling

Workshop: regulatory strategy

Presenter

David Howlett (More...)

In 2003 David established PharmaDelivery Solutions Ltd as a specialised consultancy service in the field of drug delivery combination products (especially respiratory) device technology. This has led to involvement in projects with focus in pulmonary, nasal and other delivery routes, with an international client base. Much of the activity of PharmaDelivery Solutions Ltd is focused in the area of development programme support, regulatory GAP analysis and generation of documentation supporting development and test programmes, together with data review and contingency evaluation.

David has over 35 years experience in the development, industrialization and approval of inhalation drug delivery systems, combination products and medical devices.

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NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate
  • 40% off the 3rd delegate
  • 50% off the 4th delegate
7-8 Nov 2022
Live webinar
09:00-17:00
UK (London)
7-8 Nov 2022
Live webinar
09:00-17:00
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 3 Oct*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

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Previous customers include...

  • Ajou University
  • Ardena Gent
  • AstraZeneca
  • Bespak Europe Ltd, Recipharm
  • Blue Reg Pharma Consult
  • Camurus AB
  • Chiesi Farmaceutici
  • CHIESI FARMACEUTICI S P A
  • Chiesi Farmaceutici SpA
  • Cilatus
  • CROMA PHARMA
  • Elcam Medical ACA Ltd.
  • Galderma
  • Grifols, S.A
  • Guerbet
  • Idorsia Pharmaceuticals Ltd
  • Instituto Grifols SA
  • Janssen-Cilag Farmacêutica Ltda
  • Johnson&Johnson
  • McNeil AB
  • medac GmbH
  • Orexo AB
  • Orion Corporation
  • Pliva Croatia Ltd.
  • Sever Pharma Solutions
  • Taro
  • TEVA
  • Teva Pharmaceuticals Ireland
  • Venn Life Sciences ED B.V.
  • Zealand Pharma A/S

I was hoping to achieve more knowledge about combination product and the regulatory documentations needed for the market authorisation and this was completely accomplished.

Greta Ferrari, Analytical Scientist, Chiesi Farmaceutici, May 22

The speaker was very clear and enabled participants to ask questions with a lot of patience and with clear answers.

Yaniv Menachem, Regulatory Affairs Specialist, Elcam Medical ACA Ltd., Nov 20

Overall content of the webinar was very good and covered a lot of topics.. The presentation was clear and included a lot of information. I believe this course was very informative and covered a breath of information in regards to combination product and i gained a lot of useful information and knowledge.

Rebekah Coke, Regulatory Affairs Specialist , Bespak Europe Ltd, Recipharm, Nov 20

The course was very good. The presentations were clear and included a lot of material. The workshops gave an idea how to think outside the box.

Chen Rozilyo, Regulatory Affairs Associate-Experienced, Taro, May 19

The speaker and content was very good. It was clear there was a lot of knowledge and the content was aimed at the right audience

Rina Joshi, Associate Director Regulatory Affairs, TEVA, Nov 18