This course is demanded by regulatory affairs managers who wish to get their people up-to-speed on current European medical device regulatory practices. This is a newly researched and updated course put together by practising medical device regulatory affairs professionals.

Attend this course and return to your office a more confident and proactive medical device regulatory affairs professional.

• This is an intensive, three-day course providing a valuable combination of lectures and interactive case studies that will help you to put theory into practice
• There will be an international speaker panel with representatives from industry, contract houses, notified bodies and regulatory agencies
• The course is a unique opportunity to meet and interact with peers and network with a large variety of leading industry and regulatory agency specialists.

Draft programme (251 KB)

Following completion of this course you will be able to:

• Determine which directives apply to which products
• Classify medical devices
• Assess borderlines issues
• Establish and maintain an internal audit programme and a supplier audit programme
• Prepare for and manage a 3rd  party audit.
• Recognising diverse country requirements
• Advise on how to conduct a clinical investigation
• Implement a copy approval process  to ensure compliance
  
  

With a growing trend in the crossover between pharmaceutical and medical device regulatory affairs, it is becoming increasingly important for pharmaceutical regulatory professionals to be aware of the issues surrounding medical device regulatory affairs.

This intensive three-day course is the best preparation for these issues including combination products (see focus), risk management, post-market surveillance (PMS) systems, the unique requirements of the In Vitro Diagnostic (IVD) Directive and the different conformity assessment routes you will undoubtedly come across in the near future.

This course will help you understand:

• The different conformity assessment routes and how to select the most appropriate route for their product
• The role of the essential requirements / harmonised standards and how to demonstrate conformity.
• The role of risk management in pre and post market phase and be able to advise on a risk management policy and procedure.
• The need for clinical evidence for CE marking 
• The needs of payers and how to include these as part of the development of the device regulatory package.
• The key elements within a PMS system
• The criteria for vigilance and the Competent Authority (CA) expectations
• The minimum requirements and CA expectations for implementing an FSCA.
• The impact of marketing literature on regulatory status
• The unique requirements of the IVD Directive

A dedicated session will discuss new legislation on the horizon, with a particular focus on the new IVD and medical device regulations and a brief look at the following:

REACH | PPE | WEEE | Low Voltage Directive | Machinery Directive | GHTF/IMDRF | RoHS | Non European requirements | Electro Magnetic Compatibility Directive

This course is the perfect foundation of your career in medical devices regulatory affairs

What previous delegates said: 

• I got a very good overview of medical devices, which I will use in my job.
• Right balance, full coverage of topics and opportunities for going into details.
• I was just delighted to see that this course was just what I have signed up for.
• Another memorable day full of interesting information, questions - very participative.
• I was impressed by the high level of presentations and presenters.
• The course was excellent for giving me an understanding of devices in general, their classification and route to market, and also about the clinical evaluation.
• Overall an excellent course, very knowledgeable and eminent speakers, great networking opportunities, my objectives were met.
• This course really gave me an understanding of the bigger picture. Having speakers with so many years experience and knowledge from different fields along with meeting professionals from different fields was an amazing opportunity. I have never learnt so much over three days in the past! I do feel much more confident in my role as a Regulatory Affairs Analyst and now have access to resources, references and guidances to help me find answers directly. Being more confident in my role and knowing where to find answers will help me support our business better and provide the needed guidance when needed.