The Howe School Alliance for Technology Management at Stevens Institute of Technology will host the lecture, “Enabling Technology: Changing the Management of Drug Safety and Pharmacovigilance,” on Thursday, May 3.
The event is part of the Evening Lecture series and will feature speaker: Michael Breggar, DPM, director, Life Sciences and Health Care, Deloitte Consulting, LLP.
Dr. Breggar is a leader in the Deloitte Consulting?s Life Sciences R&D Practice. He has almost 30 years of professional experience in life sciences and health care consulting. He is a recognized industry leader and speaker in the fields of R&D and life science product development, pharmacovigilance, technology and process optimization in R&D, computer-related system compliance and quality systems. His strong background in drug development, regulatory and industry affairs complements years of hands-on experience of analyzing pharmaceutical operations and processes for compliance with relevant regulatory authorities and doing so utilizing the most effective and pragmatic means.
Such is the case of pharmacovigilance and drug safety. Despite years of dealing with issues of adverse event management and reporting, the regulated industries still tend approach this as a data management activity rather than a quality-based function.
“This could be a result of the way the regulations have been written or a technological and process disconnect. Regardless, the industry as a whole respects the intent of pharmacovigilance/drug safety and understands that this information could and should be used in a manner to help produce safer drugs and medical products and better communicate the risks and benefits to its consumers. This is also true of the regulators,” said Breggar.
“So, what has happened along the way? Why is the public so distrustful of the industry and doubtful of the rigor of regulatory review? While at the same time believing the regulators stifle innovation and the approval of remarkable medicines? Is it time for the industry to be more diligent than vigilant? Should the industry and regulators operate on concepts of pharmacodiligence rather that pharmacovigilance?” he asked.
This lecture will be held on Thursday, May 3 in The Babbio Center, room 122, from 6 p.m. to 8 p.m.