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Doug Gentilcore
CEO, ARTMS Inc.
Liimu McGill
CEO, LSM Consulting
John Harkins
Former Senior Director, GPV Operations Management and North American Compliance & Business Management, Otsuka Pharmaceuticals
Penelope Przekop is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial expertise. Her diverse experience includes developing and implementing strategic fit-for-purpose corporate compliance solutions for late phase development companies, including due diligence and IPO readiness. She has served as Fractional Corporate Compliance Officer and Data Protection Officer. Her unique blend of GxP, corporate compliance, and business development knowledge enable her successful leadership throughout drug development and commercialization.
As PDC’s consulting attorney, Robert ("Bob") draws from the extensive experience he gained at the FDA where he was responsible for performing policy analysis and evaluations while also providing skillful advice on compliance and enforcement issues (such as Warning Letters, seizures, injunctions, import detention/refusal, etc.). During this time, he was active in a variety of agency working groups, including the Agency-wide Marijuana Working Group, the Agency-wide CBD Policy Working Group, and the Agency-wide Investigational New Drug (IND) Policy Working Group. Bob has also served in both the Commissioner’s office and the Center for Drug Evaluation and Research (CDER), where he worked in the areas of health fraud, over-the-counter drugs, and pharmacy compounding.
Bob previously served as Partner and Co-Chair of the Food & Drug Practice and Dietary Supplements industry team at Arnall Golden Gregory (AGG); he was also a member of the AGG Healthcare Practice and Life Sciences industry team.
Currently, Bob is Partner and Co-Chair of the Regulatory Group at Amin Wasserman Gurnani.
He holds a JD degree from Widener University Schools of Law, an MS degree in Cell/Cellular and Molecular Biology from the University of Hawaii at Manoa, and a BS degree in Pharmacy from the Philadelphia College of Pharma and Science.
Include quality and customer satisfaction strategies and goals in all levels of the company. Relay and demonstrate the expectations, and then hold employees accountable. Everyone should know that the company’s commitment to quality is real; it’s not just pretty words on paper.
Include quality and customer satisfaction strategies and goals in all levels of the company. Relay and demonstrate the expectations, and then hold employees accountable. Everyone should know that the company’s commitment to quality is real; it’s not just pretty words on paper.
In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can we remain loyal to our shared code while also supporting the innovative solutions and approaches of the modern world?
In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can we remain loyal to our shared code while also supporting the innovative solutions and approaches of the modern world?
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
In an interview with PerceptivX, Penelope shares exclusive insight on her background and why it’s high time to revolutionize regulatory compliance strategy in the pharmaceutical industry. She also spoke about the importance of leading authentically, overcoming fears to achieve goals and things she’d like most to change about the world.
In an interview with PerceptivX, Penelope shares exclusive insight on her background and why it’s high time to revolutionize regulatory compliance strategy in the pharmaceutical industry. She also spoke about the importance of leading authentically, overcoming fears to achieve goals and things she’d like most to change about the world.
