Webinar: Embracing Agility: Critical for the role of QARA professional?

Michael has close to 20 years of knowledge and experience leading localized and global teams in regulatory affairs and quality assurance and has worked within the medical and surgical, orthopedic, in vitro diagnostic, diagnostic imaging, dental and urology sectors.

As Senior Director of Product and Strategy within the Technology Solutions business of IQVIA, Michael is responsible for ensuring that the Life Science Solutions have the necessary functionality to support the increasingly complex and diverse global regulations. He is particularly focused on optimizing business workflows through intelligence-driven simplification and automation within and across the safety, regulatory and quality functions.

Marcelle Cortezia is a distinguished professional with about 25 years of exemplary service in Pharmaceutical and Multinational multinational corporations, acting in leadership position for more than 20 years. She currently holds the position of LATAM Quality and Regulatory Director at Dentsply Sirona and is also the Global Chair of DS Women.

She is specialized in Regulatory Affairs, Quality Management Systems and R&D. Skilled in optimizing the use of internal and external resources. Experienced in Regulatory MoH liaison, GMP, Quality Control, Microbiology, Validation, QbD, ISO and CE certifications. Open to change and innovation. Strong expertise in regulatory strategy development and navigating complex regulatory landscapes. Possesses strong leadership and communication skills and is passionate about diversity and inclusion with a background of consistent international exposure. As enthusiastic as she is about business and project development and management, Marcelle is a leader who empowers women and inspires countless individuals to reach greater heights with her accomplishments, strategic skills, and compassionate demeanor.

Dr Gabriel Adusei has over 33 years of experience in the medical device industry interspersed with academic studies and professional career positions.

He has worked on many high-profile projects in the medical device technology industry in many different capacities influencing global regulatory practice with a number of articles he has authored and many meetings he has participated in as a keynote speaker.

His areas of expertise include Quality Management Systems and Regulatory Affairs covering Product Research, Design and Development, Risk Management, Usability and Human Factor Engineering, Biological Evaluation and Biocompatibility, Clinical Evaluation (including clinical investigations and trials), SaMD, Connected Intelligent Health and Medical Devices, Information Security Management System and Data Protection among many others.

He was a Lecturer in Dental and Orthopaedic biomaterials and a Subject Matter Expert when he worked for BSI and Intertek (Notified Bodies) as Technical Reviewer and an Auditor where he gained extensive experience of auditing many dental and orthopaedic companies worldwide.

He has a PhD in Biomaterials Science at King’s College, London and part of his research, design and development activities have led to publications on dental and orthopaedic restoratives and devices.

Lori is the head of insights at BioSpace. She analyzes and comments on industry trends for BioSpace and clients. She creates engaging content for clients to support their marketing objectives. She has been part of an award-winning marketing team and has won a Muse Creative award, a Vega award and several Adobe awards in collaborative team projects for her audio narration work. Her experience in the television/film and audio industries benefits both BioSpace and partners through her moderation and hosting of live and virtual events. While she has covered all elements of the drug development process, her primary focuses are women’s health issues, the economic climate, and the ever-evolving impact of technology – specifically artificial intelligence – on the pharmaceutical industry.