In 2021, Chinese pharmaceutical companies have learned the challenges and pressures of get IND & NDA approval overseas. In 2022, going overseas to get IND & NDA approval is still a major trend, but challenges and pressures still exist. For example, how to put this goal into practice? How to formulate the strategy and tactics of China, USA IND and NDA as well as Global IND and NDA? How to prepare MRCT protocols that meet the requirements of FDA, EMA, TGA and other regulatory organizations? How to make full use of the incentive policies and measures provided by FDA and other regulatory organizations such as accelerated approval, breakthrough therapies and fast track?
In order to help Chinese pharmaceutical industry and enterprises meet the challenge, go overseas to get IND & NDA approval, DRUG TIMES and ACADEMY OF CLINICAL RESEARCH AND STUDY (AOCRAS) have reached strategic cooperation and establish the International CMO School. They hope to share the latest valuable cutting-edge technology and enhance exchanges and cooperation between Chinese and foreign pharmaceutical regulatory authorities, pharmaceutical enterprises, hospitals, research institutions and universities by holding online and offline activities. Also, they hope to cultivate a large number of international clinical research talents for Chinese pharmaceutical enterprises.
DRUG TIMES and AOCRAS have prepared a blockbuster event, the 2022 China, USA IND and NDA & Global IND and NDA Summit Forum. They invited professors, clinicians, chief medical officers and other experts from home and abroad to attend online to share their valuable professional knowledge and rich first-hand experience and answer your questions. Some of these experts have been in charge of the review and approval of new drugs in the drug regulatory agency. Some of them have been providing consulting services for the regulatory agency. Some are clinical trial PI or lead clinical trials and IND & NDA in the new drug company. All of them are experienced and experienced.
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