For medical translation service providers, it is critically important to stay abreast of the latest regulatory developments. The regulatory complexities that permeate the industry have made it critical for translators, account managers, and project managers to have a rudimentary knowledge of these matters as well. However, many medical translation providers are not well-versed in the essentials of approval processes and the regulatory hurdles of the post-approval period.
Sure, we offer almost daily audio conferences around regulatory, clinical, and quality topics. But sometimes it's nice to go out and mingle with colleagues and industry experts.
American Conference Institute's FDA Boot Camp has been designed to give attendees a strong working knowledge of core FDA competencies. The conference will take place on March 24 and 25, 2010 in New York.
A faculty of top FDA regulatory experts will share their knowledge and help attendees:
- Master the basics of the application and approval processes for drugs, biologics, and devices;
- Comprehend the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR;
- Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices;
- Learn how devices are classified, monitored, and regulated;
- Appreciate the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products;
- Recognize the pivotal role of labeling in the drug and biologics approval process;
- See the importance of cGMPs to the post-approval regulatory process; and
- Navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls.
ForeignExchange's METRiQ quality system provides medical device and pharmaceutical companies with measurable, known translation quality. To learn more, contact ForeignExchange Translations.