Sha L. Email & Phone Number

District De Bülach, Zurich, Suisse

-Performing clinical evaluation for coronary or peripheral vascular intervention devices (Initial submission or annually updating) under EU MDR 745/2017-Formulating Literature search keywords to conduct literature search and appraisal -Planning, authoring, reviewing clinical documentation for submission to Notified bodies (e.g: BSI)-Supporting and reviewing clinical documentation for submission to NMPA, FDA and Health Canada-Making strategy and preparing responses to… Show more -Performing clinical evaluation for coronary or peripheral vascular intervention devices (Initial submission or annually updating) under EU MDR 745/2017-Formulating Literature search keywords to conduct literature search and appraisal -Planning, authoring, reviewing clinical documentation for submission to Notified bodies (e.g: BSI)-Supporting and reviewing clinical documentation for submission to NMPA, FDA and Health Canada-Making strategy and preparing responses to Health Authority questions during global market access and maintenance-Supporting development of de novo products to define clinical strategy (pre-market and post-market follow up)-Supporting product and process risk analysis -Coordinating with external sources (e.g: CRO) and reviewing related documentations for submission Show less

Lonay, Vaud, Switzerland

• Develop new and update existing Clinical Evaluation Reports (CER), Clinical Evaluation Plan (CEP), Risk Benefit Analysis (RBA), Post-market Clinical Follow-up (PMCF) Plan/Report in compliance with MDR• Author or review state-of-the-art (SOTA) literature documents • Collaborate with multiple stake holders/cross functional teams such as Medical Affairs, Systems Engineers, Regulatory, and Quality personnel

Lausanne Area, Switzerland

Lausanne, Vaud, Suisse

Completed a comprehensive online MSL training course conducted by Dr. Martijn Bijker and his team where I gained a thorough understanding of:- Pharmaceutical Industry- The responsibilities and day-to-day activities of an MSL- The objective of an MSL- How the MSL interacts with KOLs- The product life cycle (PLC) of a drug and the role of the MSL during the different stages of the PLC- The compliance code of conduct

Switzerland

Under supervision of Prof. Mehdi Tafti and Dr. Anne Vassalli to find out the functions of Hypocretin (Orexin) receptors 1 & 2 signaling in neural circuits regulating arousal.

Düsseldorf Area, Germany

Working in the lab of Prof. Haas at Heinrich-Heine University in Düsseldorf Germany, to obtain systematically patch-clamp training to explore ursodeoxycholic acid (UDCA) in promoting wakefulness.

Région De Lyon, France

Explore the role of histamine in arousal regulation by using transgenetic mouse model.

Kunming City, China

Trained systematically as generalized medicine (4 years) and finished one year internship in all departments of First People's Hospital of Yunnan Province (Kunhua Hospital) in Kunming. In 2008, board certified generalized physician.

Ai In Healthcare

Diploma Of Advanced Study, Clinical Research, 5.5/6

Activities and Societies: ¡ Methodology of clinical trials, data management and analysis. ¡ Ethical principles of clinical.

Certificate Of Advanced Studies (Cas) En Recherche Clinique, Science / Recherche Clinique En Laboratoire Médical Et Professions Paramédicales

Activities and Societies: Epidémiologie clinique; Méthodologie de la recherche clinique; Statistiques.

Certificate Of Advanced Studies (Cas), Management Of Biotech, Medtech & Pharma Ventures

Activities and Societies: IP Strategy,Clinical Trial,Regulatory Affairs,cGMP,Project Management, Data Management.

Doctor Of Philosophy - Phd, Life Science

Master Of Physiology, Physiology In Medicine

M.D, Medicine