Wednesday, November 16th, 10:00 AM ET
Presented by
Informa Pharma Intelligence and Lachman Consultants
HOSTED BY
Maire Gerrard
Managing Editor, Custom Content, Pharma Intelligence
The life sciences industry is currently experiencing a period of sweeping digital transformation, propelled by initiatives like Pharma 4.0™ and progress in embedding artificial intelligence (AI), machine learning (ML), and robotic process automation (RPA) into both pharma operations and medical devices. While human intervention in some ordinary processes may be minimized, there is an urgent and increasing need to scrutinize data in order to that ensure quality standards are maintained and compliance requirements adhered to.
This valuable roundtable discussion will cover how drug developers must create a nexus of the right workforce skillsets, technologies, quality systems, and culture for successful data integrity strategies in a time of digital evolution.
The featured topics will include:
- Challenges in embedding AI, ML, and RPA into drug development.
- Regulatory considerations and the importance of data integrity.
- The data benefits of embedding new technologies into drug development.
- Key considerations for building a successful digital transformation strategy.
- How to build sustainable data governance.
- What does the future of data look like as digital potential evolves?
SPEAKERS:
Scott Deckebach, MBA
Director
Lachman Consultant Services, Inc
Mr. Deckebach has more than more than 25 years of experience in the life sciences including APIs, pharmaceuticals (Rx and OTC) biopharmaceuticals, aseptics, and medical devices. He is familiar with FDA and EMEA regulations including cGMP, ISO, MDSAP, EU MDR 2017/745, Occupational Health, Drug Enforcement, Environmental Production Compliance, and other industry regulations and guidances.
Patrick Day, M.S.
Principal Consultant
Lachman Consultant Services, Inc.
Mr. Day is a Principal Consultant at Lachman Consultants with over 25 years as a practitioner in the Pharmaceutical Industry. His expertise is leveraged in order to assist and guide companies to achieve success in the journey of Data Integrity. His work in Data Integrity has integrated data governance, risk management and business insight to help turn data into practical insight and great compliance.