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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.

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

7-8 Nov 2022

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  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

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

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The Development of Combination Products: Critical Interactions course will cover:

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

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David Howlett

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.

More details

Book Development of Combination Products: Critical Interactions Live online training

NEW higher discounts for multiple bookings - 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 online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 11754

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 03 Oct

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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's Development of Combination Products: Critical Interactions training course


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

May 5 2022

Greta Ferrari
Analytical Scientist, Chiesi Farmaceutici

Nov 17 2020

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 17 2020

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

May 9 2019

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

Nov 6 2018

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

United Kingdom

  • AstraZeneca
  • AstraZeneca (Macclesfield)
  • Bespak Europe Ltd, Recipharm
  • Chiesi Farmaceutici SpA
  • TEVA

Sweden

  • Camurus AB
  • Johnson&Johnson
  • McNeil AB
  • Orexo AB

France

  • BlueReg
  • Guerbet

Ireland

  • Cilatus
  • Teva Pharmaceuticals Ireland

Israel

  • Elcam Medical ACA Ltd.
  • Taro

Italy

  • Chiesi Farmaceutici
  • Chiesi Farmaceutici S.p.A.

Netherlands

  • Sever Pharma Solutions
  • Venn Life Sciences ED B.V.

Spain

  • Grifols S.A
  • Grifols S.A.

Switzerland

  • Galderma
  • Idorsia Pharmaceuticals Ltd

Austria

  • CROMA PHARMA

Belgium

  • Ardena Gent

Brazil

  • Janssen-Cilag Farmacêutica Ltda

Croatia

  • Pliva Croatia Ltd.

Denmark

  • Zealand Pharma A/S

Finland

  • Orion Corporation

Germany

  • Medac GmbH

Korea, Republic Of

  • Ajou University

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Run Development of Combination Products: Critical Interactions Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training expert Aleksandra Beer to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy