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CGT Courses, Medical Device & IVD Courses, Pharmaceutical Training Courses, Regulatory Affairs, Regulatory Courses
Regulatory Affairs for Combination Products (Drug/Device and Device/Drug)
5 & 6 December 2023 | Hybrid Training | London
£1,195.00 – £1,395.00
The price is for both days | Register for Module 1 | Free
Fully grasp the regulatory pathway for combination products to ensure fast approvals (Includes Biotech & ATMPs)
Course Overview
Combination products pose regulatory difficulties as the requirements of medical devices must merge with pharmaceuticals and biotech. As biotech and advanced therapeutics grows, so too does the need for specialised device delivery systems resulting in an increase in combination products. Similarly, device companies are increasingly adding medicinal substances to improve products.
This combination product training course provides you with the skills and knowledge to navigate both the pharmaceutical and device regulations. You will examine the regulatory pathways for drug/device and device/drug products. You will examine small molecules, large molecules and ATMPs in combination with devices. Importantly, you will learn how to merge the two regulatory systems in areas such as risk management, quality and clinical.
This course is delivered by two experts. Richard is an experienced regulatory and quality professional for medical devices and IVDs. Andrew is a leading expert in regulatory affairs and quality for pharmaceuticals, biotech, biosimilars and ATMPS. With both experts you will gain practical insights into developing a successful combination product strategy.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training. If you have any concerns about COVID-19 before registering on to the course, please read our COVID-19 commitment.
What is a Hybrid Training Course?
You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.
We recommend visiting our website to learn more. Click here to learn more about hybrid training at Educo Life Sciences.
Register For Free Online Session
There are limited spaces on the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
Key Learning Objectives
- Examine the key differences in regulations between device and medicinal products
- Understand regulatory pathway for small molecule, biotech and ATMP combination products
- Review MDR Article 117 so you fully understand how to seek Notified Body Opinion (NBOp)
- Specifically examine the drug/device regulatory pathway, reviewing the medicinal submission process (CTD)
- Fully grasp the device/drug pathway, understanding the technical files required
- Learn how the device and medicinal regulatory pathways merge in areas such as the GMP/ISO 13485 and regulatory submissions
- Discover best practice to manage the two regulatory systems in unison to ensure compliance fast approvals
- Review the regulatory landscape in the EU and US for combination products to ensure speedy market access
- Understand specific design and development challenges for combination products to reduce delays
- Analyse the clinical requirements for both devices and medicinal products to ensure you are aware of the overall combination landscape
- Learn about the regulatory and quality framework for pharmaceutical products
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
Hybrid Training Information
The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. For classroom attendees, refreshments are served from 8:30 AM. For online attendees, you will receive joining instructions.
Post Learning Implementation Plan (PLIP)
Pre-course
- Access to the Educo Training Portal
- Submit your needs analysis and objectives for training by completing a simple online form
Action Plan
- At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge
Reinforcement Session
- Delivered 3 to 4 weeks after the training
- It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Introductory Online Module
FREE to Attend | Live & Recorded
5 October 2023 | 1:00 PM (UK)
Delivered Online
Overview of the regulatory landscape for combination products
- Review the definition of a combination product
- Medicine-device borderline and classification
- Examine the major differences in regulatory affairs between medicines and devices
- Review the regulatory pathway for combination products in the EU and US
Register For Module 1 | Free
There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
Day 1
5 December 2023
Defining a combination product in the EU and US
- Review the definition of a combination product
- Legislation
- EU v US
- Review the regulatory pathway for combination products in the EU and US
- Medicine-device borderline and classification
Development process
- Development considerations for a combination product
- Development overview of medicinal products (small molecule, biotech & ATMP)
- Development overview of medical devices
Workshop
In this workshop you will review and analyse various borderline classification examples.
- Latest version of borderlines
- In groups you will examine and review examples to work on
- Discuss EU and US regulatory processes
Understanding Medical Devices
- The EU Medical Device Regulation
- UK regulatory landscape
- CE Marking and Notified Body Interaction
- Labelling
- Vigilance
- Roles of Competent Authorities (CA) and Notified Bodies (NB)
- Impact of the Medical Device Regulation (MDR) on combination products
Medical devices technical file
- What is required?
- Structure
- Clinical and post market obligations for your device
- Review biocompatibility
- Risk management
- Human factors
Day 2
6 December 2023
GMP / ISO standards
- Key questions and practical implications
- Examine how to merge both quality systems
- Interpretation of standards
- EU v US
Medicinal regulatory submissions
- Examples of small molecules, biotech and ATMPs will be used throughout
- Understanding the CTD – Common Technical Document
- Data Expectations withing the CTD
- Examine all five modules of the CTD M1-M5
- Where to place information, specifically for combination products
- Deep dive into module 3 of the CTD – CMC, quality guide for combination products
- CQA Pyramid
NB opinion for drug/device
- Examining MDR Article 117
- Reviewing the Notified Body (NB) preliminary assessment for drug/device products
- What do NB’s want to see?
Key Considerations for regulatory strategy
- Deciding a regulatory route
- Considerations for small molecules, large molecules and ATMPs
- Device/Drug registration
- Drug/Device registration
- Labelling
Andrew Willis is a Regulatory and Development consultant with 35 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.
Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.
Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. More recently for IO Biotech, Andrew was SVP of Quality, Regulatory and CMC sitting on core C-suite providing CTO support activities – overseeing all pharmaceutical development of drug substance and drug products for peptide molecules and ensuring appropriate quality systems are in place.
He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.
Richard Young has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to combination products. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.
Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.
Richard has delivered both online and classroom training courses on drug/device combination products. He has supported many professionals with their understanding of the regulatory framework in both the US and EU. Drawing on his extensive industry experience, Richard provides examples and case studies during the training.
This course is suitable for professionals who work with either drug/device or device/drug combination products. It is ideal for pharmaceutical professionals who are combining a device with their medicinal product. Likewise, it is suitable for device professionals who are looking to add a medicinal element to their product.
These include medical device and pharmaceutical professionals in the following roles:
- Regulatory Affairs
- Quality
- Design & Development
- Clinical
- Management.
Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.
The course is held in the following venue:
Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ
Free Online Module and Pricing
- Module 1 is free to attend and is delivered online and is recorded.
- To enrol onto module 1, please submit your details in the form.
- Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
- There are price tiers for this course. The dates of these are at the located above the course overview.
Could your team benefit from this course?
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
| * | • The training course is delivered either online or in a classroom. Please check which course format you have booked. |
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Gedeon Richter Plc. (verified owner) –
Experienced trainers with a sense of great humour. Recommended course to keep up-to-date with new regulations.
Ferrer Internacional, S.A. –
N/A
Swedish Orphan Biovitrum AB –
N/A