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Good Clinical Practice: When Good Studies Go Bad

  May 30, 2019  
CfPA-The Center for Professional Advancement, Online Live
July 30, 2019 at 2:00–3:30 p.m. (ET)

Who Should Attend?
This course is intended for professionals in all life science industries using human subjects in investigation. It will be beneficial to anyone planning, conducting, monitoring, managing, analyzing, or otherwise supporting human clinical trials. This program is especially valuable for onboarding any employee involved directly or indirectly in clinical trial planning and execution, to ensure alignment on GCP culture and fundamentals within your organization prior to engaging in work that impacts GCP compliance.

Course Description
Good Clinical Practice (GCP) is more than a stack of guidelines and pithy, difficult to interpret language. It is the result of decades of advancement and discovery in medicine; of human decisions both well-intentioned and not; and of consequences ranging from unfortunate to horrific. GCP is a codification of the very hard lessons we have learned as we have strived to diagnose, treat, and prevent illness and injury, and represents our best understanding today of how we can balance the benefits of bringing groundbreaking medical products to market with the risks inherent to experimentation. This 90-minute accredited course will put GCP into historical context, inform participants how they can find resources and implement GCP, and examine how they would handle GCP-related situations in their organization.
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Lucia Mokres, Consultant to the Biotechnology Industry

Dr. Lucia Mokres is a Biotechnology Entrepreneurial Consultant based in the Bay Area, specializing in helping early stage companies with novel technology gain traction and develop an investable technology and business model, and helping later stage companies work through regulatory and clinical challenges. Prior to establishing her consultancy, she was the Chief Medical Officer of EpiBiome, Inc., a precision microbiome engineering company that employs a genomics approach to profiling complex microbial communities, and deploys bacterial viruses to selectively eliminate problematic bacteria without the use of small-molecule antibiotics in humans, animals, and plants. In this role she leveraged her clinical, research, and industry background to provide medical oversight and strategic direction for all clinical development activities, defined regulatory strategy, supported marketing and business development activities, and served as the medical point of contact for external stakeholders. Prior to joining EpiBiome, she served as a Principal Clinical Scientist and medical advisor at Evalve (acquired in 2010 by Abbott Vascular), supporting medical safety and development of the MitraClip, a minimally invasive device used to reduce mitral regurgitation without the need for open heart surgery. Prior to joining Evalve, she served as a Program Specialist at Hantel Technologies, a contract medical device engineering and manufacturing firm, serving as a liaison between clients and internal departments, and managing timelines and budgets for projects ranging from single person startups to Fortune 500 companies. She completed her postdoctoral fellowship at Stanford University School of Medicine in the Department of Pediatrics. 

In her spare time, she instructs a Stanford Medical School elective, which provides training for medical students, nurses, physicians and other healthcare professionals in bedside manner, teamwork, leadership, and nonverbal communication skills; serves on the Association for Women in Science STEM to Market Advisory Board; is a member of the AWIS Palo Alto Mentoring Committee; and mentors other early stage companies through the Springboard Enterprises and California Life Sciences Institute advisory programs. 

She completed her postdoctoral fellowship at Stanford University School of Medicine in the Department of Pediatrics, and graduated Cum Laude with a Doctorate in Veterinary Medicine from Colorado State University College of Veterinary Medicine and Biomedical Sciences.


Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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