Clinical Medical Staffing

09/10/2016

The EMA has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and efficacy of medicines and to monitor their benefit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities. http://www.centerwatch.com/news-online/2016/08/15/ema-releases-data-integrity-guidance/

The EMA has released new good manufacturing practice (GMP) guidance to ensure the integrity of data

07/10/2016

"Zebrafish larvae have evolved into a very attractive model for drug discovery. Recently published methods facilitate genetical engineering of zebrafish, allowing the study of targets of interest in an easily accessible vertebrate system: a multiorgan culture model. Zebrafish is being used in Roche pRED for both safety and efficacy studies."

Zebrafish larvae have evolved into a very attractive model for drug discovery. Recently published methods facilitate genetical engineering of zebrafish, allo...

04/10/2016

Clinical Medical Staffing is looking for an experienced Quality Engineer for one of her clients. The Quality Engineer is well organised, a team player, pro-active and enthusiastic about his/her discipline. As Quality Engineer you have experience or works in a big Medical Devices Company.
In this position you will inspect manufacturing documents and operate the final documents before releases into the market.
You will coordinate input out of the market and manage negative feedback, complaints and returned goods.

See link for full article http://bit.ly/2dGwtHV

30/09/2016

Wat doe je tegen nachtelijk bezoek van monsters. Kijk hoe origineel deze dokter daar mee om is gegaan.

26/09/2016

Weet je hoe een liefdesbrief van een cardioloog aan zijn vriendin eruitziet? Is het huwelijk nu wel of niet goed voor het hart?

23/09/2016

From idea to medicine - Drug development at Roche

1,000,000,000 CHF invest 7,000,874 hours of work 6,587 experiments 423 researchers 1 drug ... it takes over 12 years and many steps since the first discovery...

21/09/2016

Clinical trials are essential to providing the scientific data to determine whether new drugs, diagnostics or procedures are both safe and effective when used to diagnose and treat people.

Clinical trials are essential to providing the scientific data to determine whether new drugs, diagnostics or procedures are both safe and effective when use...

18/09/2016

Wat mooi hoe deze handen omsmelten in een hart.

16/09/2016

Recent legislation is encouraging clinical trials in children, including the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Yet clinical trials in children commonly go either uncompleted or unpublished, according to a comprehensive study conducted by researchers at Boston Children’s Hospital.

Clinical trials in children commonly go either uncompleted or unpublished, according to a study conducted by researchers at Boston Children's Hospital.

14/09/2016

"We want to help manufacturers and researchers take the least burdensome approach to getting safe and effective products to market, said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health. "This guidance will help manufacturers and researchers better understand the FDA's basic expectations for clinical trials. We encourage researchers to contact the FDA to discuss the most practical approach to studying their device."

FDA Seeks Comment On Proposed Guidelines For High-Quality Clinical Studies - The U.S. Food and Drug Administration (FDA)

12/09/2016

Why do new drugs fail to reach the market? Oh boy, what a question — one sure to cause a stir anywhere you go. Regulators get much of the blame from industry and, to an increasing degree, vice versa.

The general impression when a drug fails is that it wasn't a good drug. Well, perhaps the chemists and formulators didn't get it wrong, but the...

09/09/2016

According to the latest industry research, about 90 percent of drugs that reach clinical stage development never make it to FDA approval and commercialization. At first glance, one could conclude that the reason is the stringent FDA review process designed to ensure that only products that deliver an acceptable efficacy and safety profile ever reach consumers. But a more detailed analysis of the results of many clinical research programs tells a different story. http://www.clinicalleader.com/doc/why-do-most-clinical-trials-fail-0001

According to the latest industry research, about 90 percent of drugs that reach clinical stage development never make it to FDA approval and...