FDA Training

2018-2-6 5:46:22


This program offers advanced training of drug management theories and methods as well as drug management regulatory practics by the US government. It allows the trainees to study the well-established new drug register mechanisms and market supervision policies through the US experience and inspires them to utilize new technologies to improve Chinese law enforcement mechanism to maximize the effectiveness and safety of the drugs. 

 

The program is themed with the reforms in drug and medical device review and approval mechanisms. It delves into the new drug research, registration, quality control and big data in manufacturing and drug regulations. The program studies the utilization of administrative power and third parties from society to boost research on drug and device innovation as well as assistance and supervision on drug development.   

 

The delegation visited Virginia Department of Agriculture and Consumer Services (VDACS). Commissioner Sandra Adams gave the introduction for the department. VDACS partners with FDA, VA Dept of Health and Va Dept of General Services on food safety issues. Commissioner Adams introduced food safety regulation and the handling of emergency food safety incidents. He also emphasized on the newly published Food Safety Program. ODF supervises food manufacturers, grocery stores, barbecue joints, seafood market and restaurants. The primary methods include on-site check, responding to complaints, sampling, training, emergency handling and food recall supervisions. The delegation engaged in a very detailed discussion on the topic.

The delegation also visited the Division of Consolidated Laboratory Services at VA Dept of General Services. DCLS executive director Dr. Angela Fritzinger offered a detailed introduction on the structure and duties of DCLS. According to Dr Fritzinger, DCLS is the only state operated general examination lab whose primary duty is to provide the citizens with high quality lab exam services, including endemic testing, special virus testing, chemicals and radioactive substance testing, environment testing, drinking water testing and newborn testing. It promotes public health by providing the high quality lab services to meet the need of Virginia in public health, environment, agriculture, consumer protection, etc. DCLS has extensive cooperation with federal agencies such as CDC, FBI, FDA and other state and local agencies. The delegation shared a dynamic discussion with Dr. Fritzinger and learned about the work mechanisms at DCLS. Guided by Dr Fritzinger, the delegation toured the labs at DCLS after the discussion. 

 

The group also visited Diffusion Pharmaceuticals Incs. Its CEO David Kalergis and Chief scientists John Gainer, Compliance Department Manager Kally and Senior Manager in Clinical Trials Harry Cook hosted the meeting for the delegation. Mr. Kalergis briefed the delegation about their new drug development focused on more effective therapeutic approaches on cancer. Using TSC a new drug developed by the company lately as an example, Mr Kalergis discussed the development stages of the TSC and the company’s compliance with FDA’s approval for third stage clinical trial. The company is eager to learn about Chinese drug regulations in preparation for their market expansion in the future as they bear high hopes for the potential Chinese market. In addition, both parties exchanged ideas regarding adverse effect monitoring and the Marketing Authorization Holder (MAH) mechanism.

     

At Virginia Board of Pharmacy, Director David Brown and Ms. Beth O’halloran of Licensing Division introduced the structure of the board and its duties. Virginia Board of Pharmacy is responsible for licensing and supervising pharmacies in Virginia. The pharmaceutical companies set up in Virginia needs to not only comply with Federal regulations by the FDA but also receive approval from the board. The board is also responsible for ensuring the company’s manufacturing are compliant with the code of FDA.  Both parties also discussed pharmacy listening approval standard, medical device licensing approval procedures and controlled substance classification and regulations.  

In addition, the delegation visiting the Johnson & Johnson factory in Pennsylvania. The plant primarily produces OTC drugs, including Tylenol and Motrin.  Senior Director of Regulatory Affairs Dr RAC and his colleagues discussed the classification of OTC and prescription drugs and the review mechanism of US drugs.  The delegation had an extensive discussion regarding FDA’s OTC regulation and Chinese generic medicines. The delegation toured the plant in three groups and received briefing from the staff on lab exam, quality controls and their streamlined manufacturing.