While many pharmaceutical drug companies are getting ready for their Risk Evaluation and Mitigation Strategy tests (REMS), mandated by the FDA, most companies are finding themselves very much unprepared. Because of better evolving and ever more complex compounds being used by drug manufactures today, it is no surprise that a better kind of evaluation process is needed for thoroughly testing these drugs. And that is why the FDA came up with REMS testing. If your pharmaceutical company is unsure about all of the components of the REMS program or is unsure whether your company is adequately prepared, it would be a good idea to contact a life sciences consulting for more expertise.
The REMS program has emerged as a key testing program to ensure better safety in the pharmaceutical manufacturing industry. In the past the FDA has been considered too lenient in the product approval process for most drug companies, but this is no longer the case. The REMS testing program ensures that optimum quality for all drugs released or they will not go into post production. Most REMS programs use web-based technology, augmented by printed materials and a very informative call center staff that can help you with any problems you might be having. These new systems allow the FDA to amass incredible amounts of information from which FDA reports are generated, tracking product usage rates, as well as educating participants and giving them timely reminder notices.
If you are confused on what to expect from your REMS testing it would be smart to hire an outside pharmaceutical consulting firm who specializes in preparing companies for REMS testing, as well as mock FDA audits, or Pre-PAI audits as well. REMS are short for 60-90 minute focused training modules conducted in person or even via web-conferencing. REMS pre-testing offers you the flexibility to update your knowledge and specifically create your learning experiences based around your pharmaceutical company’s needs, as well as your budget constraints.
REMS testing forces manufactures to work closely with physicians, distributors, even consumers in a more detailed and complete way. Preparing for this test will help your company take a better look at itself in a more scientific way, and a closer look at how your products are being used, and in what way. It also provides an avenue for drug companies to have a more clinically based conversation with consumers and pharmacists about what is in the drugs they use, and how to properly administer them. REMS testing is a great quality control system administered by the FDA, and it looks like it is here to stay.
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