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INSIGHTS / THE EXPERT: Hamish King & Guo Ning - Regulatory Strategy for European Biotechs in China post COVID

Hamish King (LLB, RAC, CFA) specialises in NMPA registration of life sciences products and has a close interest in the regulatory implications of digital healthcare and AI applications

He is the COO Cisema Beijing Consulting Ltd., a one-stop service provider for product certification, post market surveillance, clinical study, quality assurance and sourcing in China. Cisema covers primarily Medical Device, IVD and Cosmetic registration as well as Drug Master Filing (DMF) and pharmaceutical products with China’s NMPA (National Medical Product Administration and also supports companies with China Compulsory Certification (CCC), Manufacturing License (SELO) for pressure bearing parts, Energy Efficiency Labelling (CEL) etc.

Hamish is a lawyer by background and regularly presents and contributes articles on China market access and regulatory pathways. 

Guo Ning (Dipl. BWL) developed a deep expertise in China market access issues via his experiences in industry, as a project manager at and as a technical compliance and product safety expert with Cisema for 15 years.

Founded in 2002 in Munich, Germany and Beijing, China, Cisema has 12 offices globally and nearly 100 full-time employees. Apart from being a service provider, they also act as local agent so international companies don't have to set up an office in China.

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November 16

INSIGHTS / THE INVESTOR: Hongbo Lu and Jack B. Nielsen - What is a Chinese VC looking for?

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November 24

The CEO Clinic: Bill Burns - Key considerations for partnering with Pharma or Medtech Companies