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Friday, June 25 • 9:30am - 12:30pm
051A: #051A: Regulatory Submissions and Interactions with NMPA: What You Need to Know

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Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-21-519-L04-P; CME 2.75; IACET 2.75; RN 2.75

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New Drug Administration Law and more than 100 regulations, guidance, policies and implementing rules are effective in 2020. The framework for regulatory oversight of China’s National Medical Products Administration (NMPA) and NMPA’s Center for Drug Evaluation (CDE) has changed significantly in the decision-making for the supervision and administration of drugs, and in the evaluation of drug clinical trial applications, drug marketing authorization applications, supplementary applications, and overseas drug production registration applications. This short course will highlight most relevant requirements and regulatory strategy to submit IND/NDA in China and discuss how to interact with NMPA/CDE effectively in the submission and approval process. Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.
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Who should attend?

Regulatory affair professionals, senior management executives, drug development professionals, project managers, clinical trial specialists, people investing in biotech product development projects, consultants and foreign regulators.

Learning Objectives

Define the drug regulatory system, reforms, and hot topics in China; Highlight the key elements of an IND and NDA application for a drug/biological product; Describe the accelerated regulatory pathways for the examination and approval of innovative drugs, e.g., oncology, orphan and cell/gene therapies; Discuss strategic considerations for the acceptance of global clinical data in China submissions; Review good practices for effective CDE interactions; Provide real-life case studies.

avatar for Chang Lee

Chang Lee

Vice President, R &A APAC, Parexel International, United States
Have a unique experience in the combination of FDA medical reviewer, CRO and pharmaceutical-biotech industries for overall regulatory and clinical strategies in new drug development. Keep track of the new paradigm and best industry practices for product development and risk management... Read More →

Friday June 25, 2021 9:30am - 12:30pm EDT
Virtual Event Virtual Event Horsham, PA 19044
  19: Short Courses, Tutorial |   09: Regulatory, Tutorial
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial