Register For Module 1 | Free-To-Attend
Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.
£1,195.00 – £1,595.00
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)
Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.
Discount has been applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,595 and live online is £1,595.
Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.
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.
You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. If you cannot make the in-person course, you can attend 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.
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
2-Day Hybrid Training
Register at the top of the page, selecting either classroom or live online.
2-Day Hybrid Training
Register at the top of the page, selecting either classroom or live online.
2-Day Hybrid Training
Register at the top of the page, selecting either classroom or live online.
If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.
For a quote, complete our contact form by following the link. Get in touch.
We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.
For more information, complete our contact form by following the link. Get in touch.
Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)
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.Â
Pre-course
Action Plan
Reinforcement Session
15 October 2024 | 1:00 PM (UK)
Overview of the regulatory landscape for combination products
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.
4 December 2024Â
Defining a combination product in the EU and US
Development process
Workshop
In this workshop you will review and analyse various borderline classification examples.
Understanding Medical Devices
Medical devices technical file
5 December 2024Â
GMP / ISO standards
Medicinal regulatory submissions
NB opinion for drug/device
Key Considerations for regulatory strategy
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:
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
Register for a 2025 course before 31st December to receive a 20% discount on early bird pricing. For some courses, this is a total saving of over 40%.
Use discount code earlyreg2025Â at the checkout to apply the discount.
There is a free-to-attend training module for this course. When you register you will have full access to the live session, recording and presentation slides.
To learn more about what is covered in the module and when it is, follow the link below.
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