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Monday, June 24 • 11:00am - 12:00pm
#116: Harnessing Power of Advanced Technologies for Digital Transformation in Regulatory Affairs

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-530-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide the insight to future of regulatory affairs in the digital world and how companies need to embrace advanced technology to disrupt the traditional way of handling regulatory information and submission.

Learning Objectives

Describe Regulatory 2.0 and the future of regulatory affairs and impact of advanced technology such as artificial intelligence and machine learning; Discuss how to build a regulatory intelligence system using voice assistant and machine learning; Illustrate how real world evidence ( RWE) gives a new paradigm shift for more predictable, effective, and value-based patient care and the use of RWE in regulatory affairs.


Susant Mallick, MBA


Regulatory 2.0 and Digital Tranformation in Regulatory Affairs Using Advanced Technology
Susant Mallick, MBA

Impact of Artificial Intelligence and Machine Learning in Regulatory Affairs
Hans van Bruggen, MSc

Automated Risk Detection using Machine Learning in Clinical Trials
Francois Torche, MBA

avatar for Hans van Bruggen

Hans van Bruggen

Senior Regulatory Affairs Consultant, Qdossier B.V.
Hans van Bruggen is Director of and Senior Regulatory Affairs Scientist at Qdossier and eCTDconsultancy. He has an MSc in Pharmaceutical Medicine from the University of Surrey (UK) and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European... Read More →
avatar for Susant Mallick

Susant Mallick

Leader and Evangelist, Healthcare and Life Sciences, EMEA, Amazon
Susant Mallick is leading Amazon AWS HCLS professional services for EMEA region. He comes up with 20+yrs of Pharma and IT background on building disruptive solutions/products in Clinical and Regulatory space. He is technology evangelist on cutting edge technology like (Artificial... Read More →
avatar for Francois Torche

Francois Torche

Chief Executive Officer, CluePoints
François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 20 years in the pharmaceutical industry, he has held positions as statistical programmer, developer and IT project leader for companies such as GSK, UCB and IDDI. During... Read More →

Monday June 24, 2019 11:00am - 12:00pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session
  • Level Intermediate
  • Featured Topics Real World Evidence,Artificial Intelligence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session