How to Manage Compliance for Cloud-based Life Sciences Systems  
AODocs
April 28, 2020 | 11 am to 12 pm EDT
 

Preview:

Webinar Description:

The cloud offers numerous benefits for pharmaceutical, biotech, and medical device companies but while the power of this revolution is recognized for innovation, collaboration, and cost, questions around data security and privacy persist.

Regulatory compliance is one area that drug and device companies must carefully consider before migrating to and adopting cloud-based services, and the lack of clear FDA regulatory guidelines in this shifted landscape remains a significant challenge.

In this webinar we explore what guidance currently exists in this area, what type of solutions exist in the cloud and how they address compliance, and finally we offer best practice guidance to organizations wanting to get value from cloud solutions.

Learning Objectives:

  • What FDA guidelines currently exist for cloud solutions?
  • What type of solutions are life sciences organizations currently using in the cloud?
  • In the absence of appropriate FDA guidelines, what is the best practice for secure, cloud-based solutions?

Speakers:

Rich Lauwers

Rogier Reijmers, PhD
Principal Scientist, Immuno Oncology Department
LUMICKS

Rogier Reijmers performed his PhD in the lab of Professor Steven Pals where he specialized in B cell development and malignancies. After acquiring his PhD, he continued his academic career in the lab of Dr. Tom Cupedo where he worked on lymph node function and how B cell follicles form. During this period he successfully obtained a highly prestigious VENI scholarship of the Netherlands Organization for Scientific Research, which he used to further study lymph node function in the control of innate lymphoid cell and T cell function. He performed this work in the lab of Professor Reina Mebius. During this period he extended his knowledge on how the lymph node micorenvironment supports B cell malignancies, and was awarded a scholarship from Cancer Center Amsterdam. At the end of his Academic career, he switched places one more time, and started working with Dr. Mirjam Heemskerk, a leading experts in the identification, characterization and subsequent engineering of human T cell receptors. Dr. Reijmers was responsible for all the preclinical work using the identified TCRs. During his academic career, he published nearly 30 papers in many prestigious journals including Blood, the Journal of Clinical Investigation, and Nature Communications. Currently as an expert in Immunology and Hematology, Dr. Reijmers is the Principal Scientist at LUMICKS where he acts as advisor for product strategy and monitors the scientific integrity for immune oncology.