About this course
To provide an in-depth overview of the roles and responsibilities of the various regulatory and technical authorities, the communication methods necessary in order to agree an regulatory affairs strategy prior to and during the conformity assessment process
You will develop in-depth knowledge, understanding and competence through a combination of lectures tutorials, course work and self- study. Lectures will be used to impart underlying principles and factual knowledge. The tutorials sessions will be used to explain and extend difficult concepts introduced during lectures. Independent and group literature research will introduce you to the literature on current Medical Devices practice. The tutor will also give guidance on the material for further self-directed study.
Learning Outcomes
By engaging successfully with this module a student will be able to:
1. demonstrate an in-depth knowledge of stakeholders within Europe with respect to medical devices, including relevant expert, specialist and scientific committees, working groups and notified bodies
2. understand the process for development, consultation and implementation of new or modified EU regulations and guidance sufficiently to take part if necessary
3. develop well thought out strategies for staying up to date with changing EU and National regulatory decisions, emerging guidance and scientific opinion
4. critically appraise the role of industry and trade associations, and identify those most relevant to your product area
Course outline
• Structure of the European Commission with respect to Medical Devices
• Competent authority communication processes and overview of the capability costs and opportunities open for manufacturers
• Communicating with notified bodies – determining the optimum time and forum
• Managing communication between medicines agencies, clinical trial site sites, competent authorities and notified bodies
• Identifying and appointing scientific technical and regulatory experts
• Joining industry and trade associations
• Creating regulatory intelligence networks and databases
Venue
AMP Technology Centre, Sheffield, UK
We have selected the Advanced Manufacturing Park (AMP) Technology Centre near Sheffield as its location and environment are ideal to centralise and control our services. Based in a region well known for its expertise in healthcare manufacturing technologies and supported by clinical and academic excellence, the Centre provides an ideal location for business events, meetings, seminars, training events and small scale trade shows. With free parking, proximity to the M1 and M18, and within an hour’s drive of Leeds, Manchester, Sheffield, Bradford, Nottingham and Leicester, it is a convenient and accessible location.
The AMP has been designed to accommodate a range of manufacturing related activities, from the work of fledgling engineering and technology companies to the University of Sheffield’s collaboration with some of the world’s foremost advanced manufacturing technology businesses, such as Boeing and Rolls Royce.
Hotel Accommodation
We have a block booking of bedrooms at both the Aston Hotel Sheffield and the Holiday Inn Rotherham-Sheffield at a specially negotiated bed and breakfast rate. Hotel reservations should be made directly with the hotel. Please quote ‘NSF’ at the time of booking.
Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure that you are aware of the hotel’s cancellation policy.
Aston Hotel Sheffield, to book please call the hotel on +44 (0) 1142 615690, quoting ‘NSF’.
Holiday Inn Rotherham-Sheffield, to book please call the hotel on +44 (0) 1709 830630, quoting ‘NSF’.
Venue Address and Contact Details
AMP Technology Centre
Advanced Manufacturing Park
Brunel Way
Rotherham
S60 5WG
England
Tel: +44 (0)114 254 1200
Fax: +44 (0)114 254 1201
An NSF International Company 
