Tag Archive: drug safety

Bart’s Corner: Coding MedDRA and ICD-10

Comparing Coding MedDRA and ICD-10

Read More

Bart’s Corner: Danish HA Guide on PV

In June, the Danish Health and Medicines Authority (DHMA), issued its Guide to Individual Case Safety Reporting. This is a 60 plus page “best practice” (their words) document describing the process for submitting individual case safety reports (ICSRs) to them using the E2B standard to “complement current EU legislation and[…]

Read More

Industry Trends Shaping the Future of Pharmacovigilance

British journalist, biographer and statesman John Morley stated, “Evolution is not a force but a process.” In an effort to continuously improve the efficacy of drugs and health outcomes for patients, the healthcare industry gradually evolves to meet changing regulations, make the most of new technologies and communication channels, and[…]

Read More

Bart’s Corner: Preparing and Coding Expedited Reports

In my thirty years in this business doing both medical and operational drug safety and pharmacovigilance, I’ve seen that just about every possible permutation of handling expedited reports has been used. In many cases, it does not matter how such reports are handled and most of the different methods work[…]

Read More

FDA Draft Guidance on Rare Diseases

  FDA Draft Guidance: Rare Diseases: Common Issues in Drug Development Guidance for Industry August 2015 In August 2015, the FDA released this new guidance on rare diseases. Its aim is to aid sponsors and manufacturers in the development of drugs and products for rare diseases (defined more or less[…]

Read More

Bart’s Corner: Late Expedited Reports to the FDA

In July, the Journal of the American Medical Association printed a Research Letter and an on-line editorial on pharmaceutical companies’ late expedited (15 day) reports to the FDA. The article (behind a paywall) can be found here. and the editorial here and here. The study is from the University of Minnesota. […]

Read More

Bart’s Corner: In Memoriam Dr. Kelsey

In Memoriam – Frances Kelsey, MD, PhD, 1914-2015 Dr. Kelsey was born in Canada and did her training there and in the US.  After working as a general practitioner, she joined the US FDA as a medical reviewer and ultimately rose to very senior positions. One of her major achievements,[…]

Read More

Compliance, Quality & Cost: Outsourcing Clinical Trial Support

Compliance, Quality & Cost: Why Outsourcing Clinical Trial Support Makes Sense for Start-Up and Mid-Sized Drug Manufacturers Clinical development of a drug or device from discovery through post-marketing approval requires a vast amount of time and resources. During the clinical trial phase, requirements and regulations imposed by governing regulatory bodies[…]

Read More

Update on Drug Safety Courses & Certificates

In the past getting training in Drug Safety (DS) and Pharmacovigilance (PV) was very difficult.  Most of it involved on the job training in the company or health agency where you worked. Most people came into it from other functions within that institution, such as a move from clinical research[…]

Read More

Monitoring Medical Literature: EU Changes

The EU and FDA have required Marketing Authorisation Holders (MAHs) to monitor medical literature for adverse drug reactions for many years. The EMA has finally put forth the details of its new system to monitor medical literature for MAHs.

Read More

The Experience Matters.

As an industry leader in business process outsourcing, C3i Solutions delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.

Contact Us