Gary Saner is a Sr. Manager of Information Solutions in the Reed Tech Life Sciences group. He is a subject matter expert on Drug Labeling, Medical Device UDI, and other structured content reporting to regulatory agencies and commercial organizations. He has over 40 years of experience in software development, process management, and data administration, with the last 19 years focused on the Life Sciences industry. With a deep understanding of regulations, business requirements, and systems, he has helped shape and implement successful solutions at Reed Tech for data management, validation, processing, and submission of Drug Labeling content, Cosmetic information, and Medical Device UDI data. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team.

Hamish King is the CEO of CISEMA, a regulatory consultancy and CRO for China founded in Munich and Beijing in 2002. A lawyer by training - admitted in Hong Kong and NSW, Australia - Hamish previously worked with UK Magic Circle Firm Linklaters in Hong Kong and has over 10 years' experience in the legal and regulatory fields. He has obtained the RAC and CFA qualifications. Regularly writing articles and speaking on China regulatory pathways and registration points, Hamish is originally from Sydney but has lived in Hong Kong for over 8 years.

Victoria Caldy is Business Development & Marketing Director at Cisema. From major multinationals to small start-ups, Victoria has over 20 years of experience providing Life Sciences clients with planning and strategy for product launches, regulatory approvals, and registrations. Her broad expertise includes building a class III medical device company from the bottom up, providing her with hands-on experience to better serve and solve the challenges of getting to the China market.

Learn more about our panelists: 

officehk@cisema.com
+852 6468 6239 / + 1 773 449 5169
cisema.com/en

Cisema is a CRO (clinical research organization) and turnkey regulatory affairs solutions provider for the China and Hong Kong markets, with a large on-the-ground contingent of local Chinese staff and satellite sales offices around the world, with a special focus on China product registration. In China, certain product groups require compulsory registration (e.g. NMPA, CCC, CEL, CML) before they can be imported, traded, and used. 

Cisema is the largest consultant company in the EU for regulatory affairs in China, with an increasing number of customers in the US, Japan, Korea, and Israel.

Cisema expertise includes the NMPA (formerly known as CFDA) registration for medical devices, IVDs, pharmaceuticals (DMF), cosmetics, health food, and other life sciences products. 

For more information, please visit Cisema.com.

LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.

For more information, please visit ReedTech.com.

Life Sciences Solutions Driven by Accuracy and Insight
Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry's data. Our offerings smooth the collection, transformation, submission, and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.