Managing excipient supply to comply with emerging and ever-changing regulations
Regulatory policies and enforcement practices for excipients vary widely across regions. Compliance expectations related to supply chain security, materials traceability and new regional pharmacopoeia initiatives have dramatically increased in the past five years.
With more to come, how can pharmaceutical companies ensure that the excipients they use are meeting these new regulatory requirements?
The pharma industry should strive to achieve more transparency across the product life cycle and engage its stakeholders (suppliers, contractors) to further improve regulatory compliance and security. Implementing a "risk based approach†will enable increased collaboration across the entire value chain and contribute toward a safe and efficacious medicine for the patient.
This webinar will discuss critical emerging regulations, and provide mechanisms and tools to stay abreast of future changes. Topics* include:
• Risk assessment for excipients in Europe
• NSF/IPEC/ANSI 363 – 2014 Good Manufacturing Practices for Pharmaceutical Excipients in USA
• System changes in China
• Brazilian Good Manufacturing Practices
• ICH Q3D Implementation in Europe and USA
• How to stay up-to-date on new regulations
• What tools are available for monitoring excipients regulations
Knowing how to manage regulatory challenges can help pharmaceutical companies find ways to speed up innovation and shorten time to market all around the world.
*Topics could vary depending on what information is publicly available on these elements before September 21.
Presented by
Patricia Rafidison,
Global Regulatory Affairs Manager Healthcare Solutions
Patricia Rafidison is Global Regulatory Affairs manager at Dow Corning for Healthcare Solutions, with additional responsibility for risk management, targeted to Healthcare applications.
She is active in International Pharmaceutical Excipient Council (IPEC) Europe since 1992, and the IPEC Federation since 2010, and is IPEC Federation Vice-President. Patricia contributed to numerous articles and presentations on excipients regulations and good practices, which include IPEC guidelines, in particular the IPEC-PQG GMP guidelines for excipients and the IPEC Europe safety guidance for novel excipients. She is actively engaged on subjects such as excipients risk assessment, certification, and global harmonisation of excipients monograph. She is a pivotal member of several excipient-related expert networks for Quality and Regulatory standards, including WHO. She is a member-elect of the French National Academy of Pharmacy.
Patricia is a Pharmacist and Doctor d'e'tat- es- sciences pharmaceutiques, awarded by the University of Pharmacy-Paris XI-France.
Katherine L. Ulman,
Global Regulatory Compliance Manager Healthcare Solutions
Katherine Ulman has been with Dow Corning Corporation for more than 39 years. She is a global regulatory compliance manager for Dow Corning Healthcare Solutions, as well as a Dow Corning associate scientist. Ulman has held positions as global technology coordinator and regulatory manager of the Dow Corning Healthcare Industries Materials Site. She has worked in the development and characterization of pharmaceutical excipient and medical device raw materials/components for nearly 25 years. Much of her earlier career was dedicated to the synthesis of novel silicone monomers and polymers/copolymers.
Ulman is a member of the American Chemical Society, the American Association of Pharmaceutical Scientists and the Control Release Society. As an active member of the International Pharmaceutical Excipient Council (IPEC) Americas, she was elected to the organization's executive board as the vice chair for Science and Regulatory Policy. She has published and presented several papers in her field and has taught international courses on silicones for pharmaceutical/biomedical applications and medical adhesives through Technomic Publishing Co.
Ulman earned her Bachelor of Science degree in chemistry from the South Dakota School of Mines and Technology in 1976.
