Dr. Zhang Lele Tel: 18652937887 E-mail: njulele@163.com
Lecture, Business School of China Pharmaceutical University
Lawyer, King & Wood Mallesons
Member, Pharmaceutical Enterprise Compliance Committee of China Pharmaceutical Innovation and Research Development Association (PhIRDA)
Member, Jiangsu Provincial Health Law Society
Member, Jiangsu Provincial Administrative Law Research Association
education experience
2004-2008 Nanjing University Bachelor of Law
2008-2011 Nanjing University Master of Law
2011-2015 Nanjing University Doctor of Law
2013-2014 Indiana University (USA) Visiting Scholar
work experience
2016 -2022Teacher Department of Pharmaceutical Administration of China Pharmaceutical University
2018-2021 Lawyer Grandall Law Firm (Nanjing)
2020-2022 Deputy Director Suzhou Biomedical Industry Innovation Center
2021-2022 Teacher Business School of China Pharmaceutical University
Lawyer King & Wood Mallesons
professional field
1. Medical and health care laws, regulations and policies
（1） Pharmaceutical regulations and regulatory science. Including: pharmaceutical regulations, drug regulatory science, pharmaceutical enterprise compliance management, etc. I am the member of the national first-class undergraduate professional team, the core member of the national-level excellence course Pharmaceutical Regulations, and have participated in the compilation of the national textbook Theory and Practice of Chinese Pharmaceutical Law. I teach pharmaceutical Regulations and Chinese Pharmaceutical Regulations (English), and has participated in several research projects commissioned by the National Health Commission, NMPA and other ministries.
（2）Medical and pharmaceutical policy. Including: medical insurance policy, centralized procurement policy, medical and health system reform, pharmaceutical industry policy, etc. I have participated in a number of research projectscommissioned by National Medical Insurance Administration, such as the reform of the national medical insurance payment method and the negotiation of the national centralized procurement, and have provide professional advice for many pharmaceutical companies to successfully enter the national medical insurance catalog or win the national centralized procurement.
（3）Pharmaceutical intellectual property rights. Including: pharmaceutical patent infringement, pharmaceutical patent linkage, etc. I have participated in many research projects of the National Intellectual Property Administration, provided drafting opinions for China's Implementation Measures for Early Settlement Mechanism of Pharmaceutical Patent Disputes and other laws and regulations, and provided professional advice to many well-known domestic and foreign pharmaceutical companies.
（4）Other health areas. Including: public health, international health, etc. I have presided over and participated in many research projects such as the project of the National Social Science Foundation and the Jiangsu Social Science Applied Research Research, have written and published many papers, and provided professional advice to medical institutions and CDCs.
2. Planning and service of the pharmaceutical industry
Including pharmaceutical industry planning, pharmaceutical industry development and promotion policies, etc. I have taken the lead in drafting the 14th Five-Year Plan of SIP's biopharmaceutical industry, participated in drafting the development plan of biopharmaceutical industry in Jiangsu Province, participated in the declaration and construction of the National Biopharmaceutical Technology Innovation Center, and participated in the investment attraction and financing services of SIP pharmaceutical enterprises, etc.
3. Services for the pharmaceutical industry
As the member of the pharmaceutical team of King & Wood Mallesons, I have provided compliance management consulting services for domestic and foreign pharmaceutical enterprises, legal services for investment, financing and M&A of pharmaceutical enterprises, legal services for IPO of pharmaceutical enterprises, legal services for overseas and domestic technology transactions (License in/out), legal services for drug registration and circulation, and legal counsel services for regulatory authorities such as the NMPA.
