Beginning with the discovery of a potential new medication, medical device or cosmetic product, and for as long as the product is available to patients, our goal is to ensure that the benefits and risks of our health care products are continuously monitored and well-understood by regulators, health care providers and patients.
Patient safety is at the heart of all we do. Our products undergo exhaustive safety monitoring and quality assurance processes at every stage of the products lifecycle: from raw material sourcing, research and development, clinical trials, production and all the way through delivery.
Medications, medical devices and cosmetics are important tools that doctors use in treating short-term and long-term dermatology problems. Utilizing medical products exactly as your doctor prescribes is the first and most important step on the road to better health.
Any medicine or medical device, no matter how safe and effective, can sometimes cause side effects. We take our obligation to report product safety information to health authorities very seriously and all of us at Galderma share responsibility for improving the lives of patients and meeting regulatory obligations. We maintain a single global safety database that monitors the safety of our medical products to ensure patient safety.
Galderma’s Global Patient Safety organization is comprised of physicians, pharmacists, nurses and other health care professionals dedicated to the collection, monitoring, evaluation and reporting of safety information through the science of pharmacovigilance.
What is pharmacovigilance? Pharmacovigilance is the process of collecting, monitoring, researching and evaluating information from health care providers and patients for the purposes of understanding and preventing drug-related problems or other medical side effects. Well before a medicine or a medical device is approved by regulatory authorities and reaches patients, it is rigorously assessed through carefully designed clinical trials to better understand its benefits and risks. The results of these studies are shared with regulators, such as the Food and Drug Administration (FDA) in the United States, so they can conduct their own assessment before approving the drug or medical device for wider use.
Galderma takes a comprehensive and rigorous approach to pharmacovigilance designed to maintain and evaluate the product's benefit-risk profile. If important safety issues arise, Galderma communicates this important information to doctors, patients and regulatory agencies in the United States.