Welcome

Dear Colleagues,

Catalyze4Life (https://catalyze4life.epfl.ch/) is happy to announce the 1st Workshop on the Development of Drugs and Medical Devices.

Come and learn from industry experts, how your technology can be turned into a product, and additionally map your career options, by familiarizing with concepts like:

 

  • Process map to product development and regulatory approval of drugs and devices 
  • Project simulation with case studies
  • Team/groups work
  • This workshop is limited to 40 participants as it shall be highly interactive. Please make
  • Certificates of attendance shall be provided at the end of the course. Please make sure you follow all the course.
  • Registration is compulsory at https://epfl.doodle.com/poll/rcff5aa3cv9deykp

Place: The Workshop shall take place at SV 1717, https://plan.epfl.ch/?room==SV 1717

Format: 1.5h presentation followed by 1.5h case studies in groups 

The content of the 3 days of the workshop is interconnected.

Schedule:

Day 1 (November 05, 2018, 14:00-17:00)

Introduction to Drug Development:

Preclinical, CMC, clinical, glossary of terms, definitions of drug, device, description of the flow of work, with explanation of the basic tasks from discovery to clinical trial submission (IND/CTA) to market,  Market Authorization Application (MAA/NDA), and post-marketing surveillance (Life Cycle Management).

 

Day 2 (November 06, 2018, 14:00-17:00):

Clinical Trials Phase 1 to 3 and GxP Compliance

(IND/CTA)

 

Day 3 (November 07, 2018, 14:00-17:00):

Medical Devices:
Introduction to the medical device design and development process and regulatory clearances/approvals (EU and USA). Emphasis on devices for drug delivery.

 

Expectations from Participants:

1.            Read background material provided

2.            Stay alert

3.            Show engagement

4.            Have an open mind

5.            Work in teams

 

The Instructors (see their Biographies Attached)

  • Gautam Maitra, Instructor, Faculty Advisory Board Member, Center for Regulatory Sciences, College of Sciences, San Diego State University
  • Claude Ammmann, Director Claude Ammann Consulting, Lausanne
  • Ary Saaman, Director, Regulatory Affairs, Debiotech SA, Lausanne

 

Key facts on regulatory affairs and drug/device development:

  • Originators in the pharmaceutical industry contribute 60 percent of the industry’s global gross value added and 42 percent of its employment (IFPMA Report)
  • The number of people employed worldwide in the pharmaceutical industry is roughly equivalent to total employment in Belgium (IFPMA Report)
  • Wages and salaries per employee rose by USD 3,000 to USD 20,600 between 2006 and 2012, an increase of 16.6 percent (IFPMA Report)
  • Gene therapy may disrupt the sector by offering customized, targeted patient treatment (2018 Global Life Sciences Outlook)
  • About 200 3D-printed devices have been approved in the last decade that can be tailored to fit a patient’s anatomy (2018 Global Life Sciences Outlook)

 

Keywords : DHF = Design History File, DMR = Device Master Record, EU MDR = European Medical Devices Regulation, Notified Body, CE-marking, US FDA = US Food and Drug Administration, 510(k) dossier, PMA = Premarket Approval, Combination Products, « safety and effectiveness

 

Looking Forward to seeing you there,

 

Dr Kostas Kaloulis & Prof Bart Deplancke

 

Posted by Konstantinos Kaloulis on Friday 28 September 2018 at 13:13
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