37.2 trillion cells, 3.2 billion base pairs of DNA, 19,000 genes encoding proteins, 2,000 active proteins functioning within a cell, 10 million chemical reactions per second in every cell across 70 organs1 - the human body is complex and every patient is unique. All of us respond to medicines in different ways, so the best drug for one patient may have the potential for side effects in another. Patient safety is our number one priority. It is more than just an obligation; it is our commitment to good medicine.
We embrace patient safety. Putting patients first is a value we all hold dear. We live this value each and every day as a trusted partner for healthcare professionals, regulatory authorities, and, of course, our patients and users.
Dr. Michael Devoy
Chief Medical Officer, Bayer Pharmaceuticals
We have a comprehensive Pharmacovigilance process which constantly monitors drugs and devices throughout their whole lifecycle as well as the effect they have on patients. Bayer has over 1,000 pharmacovigilance experts who analyze side effects and develop measures to minimize or even prevent them. In a nutshell, they constantly keep an eye on the safety of patients who use our products.
It takes around 10 to 12 years and costs over one billion Euros to research and develop a new drug. Scientists study how well a drug works (efficacy), tolerability and safety of a new medicine in their effort to bring new treatment options to patients. In order for a new treatment to be approved, the drug has to show its benefits are greater than its risks.
The benefits and risks are continuously assessed for as long as the drug is on the market. We also rely on individual feedback as to how the drug is performing from both doctors and patients.
Regulates clinical trials of medicines and medical devices. Assesses clinical data and authorizes medicinal products for sale. Post-marketing surveillance for monitoring and reporting of adverse events. Promotes safe use of medicines and devices and ensures compliance with statutory obligations.
Weighs up benefits and risks of available treatments for each patient. Prescribes medicinal products and devices. Monitors and manages reports of suspected side effects. If confirmed, the healthcare professional reports the suspected side effect to the authorities.
1 SAP, Performance Databases - www.brmassocllc-org.com/Singh_20150608_HighPerformanceDB.pptx Last accessed May 2018