Post Conference Regulation Focus Day

9:30 AM - 10:00 AM Registration and Coffee

10:00 AM - 12:00 PM Troubleshoot the Regulatory Landscape

Keith Summerhayes, Managing Director , MDCRQ Solutions Ltd
This workshop is designed to look at how to map the different regulations for the development of Combination Products. With the complex regulatory landscape causing confusion, we will look at how to determine which guidelines should be followed for which product.

Attend this workshop to:
  • Analyse the different regulations for different products
  • Understand what changes come into practice in the development of novel combination products
  • Hear new practical approaches for structuring the progress of your development strategy
Keith Summerhayes, Managing Director and Clinical Affairs Consultant, MDCRQ Solutions
About Keith:
A Senior Clinical Research Professional with significant technical & managerial skills and international experience, gained during the past 35 years, with major US & European ‘blue chip’ Pharmaceutical, Contract Research and Orthopaedic Medical Device Corporations. Has also obtained significant experience in start-up medical device companies and has run his own Consultancy Company for nearly 9 years.

Keith Summerhayes

Managing Director
MDCRQ Solutions Ltd

12:00 PM - 1:00 PM Lunch Break

2:00 PM - 4:00 PM Set the Scene: Navigate the Different Regulations For Different Combination Products

With many regulations to factor in for both drug and device approaches in combination product development, this workshop will map out a timeline of when to factor in what standard and consolidate your risk assessment.

Attend this workshop to:
- Map the different risk assessments that need to be addressed during product development
-Consolidate the standards into a streamlined process
-Understand what elements need to be changed with differnet aspects of the products that are altered