Development of Combination Products: Critical Interactions

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

12-13 May 2020

& 17-18 Nov 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

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 seminar will clarify the EU and US approach to drug/device and device/drug combination products, address the requirements for the device technical le/ design le and explain the biological and synthetic drug regulations and the registration procedure for these products.

The programme will also cover the regulatory strategy to adopt and the relevant aspects of GMP and quality processes, including the data expectations for the Common Technical Document. Delegates will nd this a comprehensive overview of the requirements for these drug/device and device/drug combination products and will have an opportunity to discuss the complexities with an expert in this eld.

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
  • 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 - Day one

Defining a drug/device and device/drug product

  • EU approach
  • US approach

Understanding devices

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

Regulatory procedures for drug/device and device/drug products

  • EU procedures
  • US and Office of Combination Products

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

Programme - Day two

Registration procedures

  • Devices EU/US
  • Medicines EU/US

GMP and ISO standards

  • Practical application
  • Interpretation of the standards

Common Technical Document (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

Presenters

Andrew Willis

An independent consultant with 32 years of experience with regulatory affairs and pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in co-ordinating, planning and running global development projects.

His experience is wide ranging, allowing fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management.

Since acting as an independent consultant his roles have included:
  • Interim Strategic advice to major pharmaceutical company for roll-out and compliance strategies for Russia / CIS, MENA, ASEAN, LATAM, South Africa and Switzerland, including ensuring appropriate staff development and strategies which ensure protection of intellectual property whilst maintain patient focus.
  • Orphan drug registrations of vaccine products and synthetic molecules
  • NCE approved in US and Europe for urology product (Simultaneous NDA and EU Centralised submission)
  • Support for NBE during clinical phases and CMC support for a Biosimilar, Biosimilar / Biologic CMC reviewer for major pharma. Biosimilar experience includes working on first EU biosimilar onwards.
  • Oversight of Regulatory strategy for ATMP (Cancer vaccine) and CMC lead for Stem Cell treatment
  • Training to major pharmaceutical companies for Chemistry and Pharmacy section of the dossier and Life Cycle Management. Additional lead training / presentations on Life Cycle Management for TOPRA.

Furthermore, his responsibilities have provided senior management oversight and direction in the following key areas: -

  • Strategic management of ATMP products for Biotech start-up company
  • Strategic Biosimilar team, developing a global biotech and biosimilar strategy for key biosimilar products.
  • Global Quality Leadership Team, providing oversight and direction for global quality processes.
  • Innovation Team, providing oversight and direction for the innovation.

Additional experiences reflect raising funds for new start-up companies and associated due diligence activities. Also he has substantial awareness of management of P & L performance, growth initiatives related to service expansion, geographical expansion and innovative business development approaches.

Andrew Willis

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

Book now

12-13 May 2020
12-13 May 2020 Holiday Inn London - Kensington Forum, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
17-18 Nov 2020
17-18 Nov 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • AstraZeneca
  • Camurus AB
  • CROMA PHARMA
  • Grifols, S.A
  • Orion Corporation
  • Taro
  • TEVA
  • Teva Pharmaceuticals Ireland

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

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