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Quality & Regulatory Requirements for Drug Device Combination Products in the UK & US

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

Quality & Regulatory Requirements for Drug Device Combination Products in the UK & US

online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

This interactive course will bring clarifications on quality & regulatory requirements for combination products in the UK & US.

Join us & discover the major differences in approval routes as well as the FDA’s approach to combination products.

meet the training leader

Dr. Tina Amini

Director

TA Medtech & Combinaiton products Consulting Ltd, UK

View trainer bio

training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Tailored for Your Professional Needs

This training course is meticulously crafted for Pharmaceutical & Medical Device professionals and companies established in US & UK markets or those who plan to expand those markets in the future.

It helps navigate through the regulatory and quality requirements of drug device combinations, offering a deep dive into the UK and US regulatory landscapes.

Quality Assurance/Quality Control Professionals: Navigate through cGMP requirements, UK Responsible Person obligations, and technical files.
Regulatory Affairs Specialists: Decode regulatory frameworks in the UK & US, ensuring compliance across all combination products.
Market Access Teams: Strategize your product's entry into the US and UK markets by understanding regulatory nuances and approval pathways.

Design and Development Teams: Immerse into regulatory and quality requirements guiding drug-device combination products' design and development phases.
Professionals Engaged with Medicinal Products Using a Delivery Device: Ensure regulatory compliance of your delivery devices, safeguarding efficacy, and patient safety.
Post-Market Surveillance Teams: Monitor, evaluate, and ensure the continued safety of combination products.

key training

Topics

UK Medical Device Regulation

UKCA marking and legal obligations

Regulation of medical devices in Northern Ireland

Combination products in US

PMO and FDA’s Assignment Algorithm

US market access for combination products

Key takeaways

Testimonials

The trainer was very knowledgeable and was able to explain the course topics very well with good examples.

A serious attempt to clarify regulatory requirements for drug device combination products.

Clearly structured way of presenting the content, actively engaging the audience, open to discussion and different opinions.

Registration

Training ticket

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

Online Live Stream

FROM

1196€

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Contact us

Andrea Weber

Sr. Manager for Pharma

Phone: +421 257 272 100

Email: event.inquiries@fleming.events

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Quality & Regulatory Requirements for Drug Device Combination Products in the UK & US