DUBLIN–(BUSINESS WIRE)–The “Development
of Combination Products: Critical Interactions” conference has
been added to ResearchAndMarkets.com’s offering.
Linking the technical requirements of device design and pharmaceutical
product development. Using QbD to deliver drug/device combinations.
What this course is about
Drug/device and device/drug combination products are becoming
increasingly important in the medical industry. The development of these
products raises a number of complex issues regarding the development
process and their manufacture. The quality and regulatory aspects to
consider are also challenging. This seminar will clarify the EU and US
approach to drug/device and device/drug combination products. It will
discuss the requirements for the Device Technical File/Design File and
will explain the Biological and Synthetic Drug Regulation and the
registration procedure for these products.
The programme will also cover the regulatory strategy to adopt for these
products and the key aspects of GMP and quality processes applicable for
drug/device and device/drug products, including the data expectations
for the Common Technical Document.
Delegates will find 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 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 Regulation and its
requirements -
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
Agenda:
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 regulation
- 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
For more information about this conference visit https://www.researchandmarkets.com/r/k7giqf
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For
E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: Pharmaceuticals,
Drug
Discovery