Drug Safety

Safety and Quality Procedure

Pharmaceutical products need to be as safe as possible and fully compliant with regulatory guidelines. Therefore, in the development of therapeutics, the evaluation of safety and efficacy of the products is mandatory. Several studies need to be performed, ranging from early research studies in animals to clinical studies in healthy volunteers and patients. These studies are highly regulated and thoroughly monitored, reviewed and evaluated both by Pharming and the regulatory authorities.

The risk benefit of the products in each indication under development or marked is continuously evaluated. Findings, and Pharming’s interpretation thereof, are reported to the relevant authorities according to legal timelines, and result in appropriate actions such as updating investigator brochures and product labeling.

Adverse Event:

In case you experience any side effects (e.g. allergic reactions) following the administration of our product (adverse reaction) please contact Pharming’s Pharmacovigilance Qualified Person (QPPV) 24 hours a day via:

EU territories:

 

Within office hours:

T:+31 (0)71 5247 110

M:+31 (0)6 2023 2906

Outside of office hours:

M:+31(0)6 45 65 93 76

By email at:

E: safety@pharming.com

Pour nous contacter (FR):

France: T:+33-975181134

Luxembourg: T:+352-20881291

Product Complaint:

Pharming’s laboratories comply with Good Laboratory Practice (GLP) guidelines and all production facilities and processes comply with regulatory Good Manufacturing Processes (GMP) guidelines. Pharming’s Quality Department conducts internal and external audits of processes, products and facilities on a regular basis. All these procedures and guidelines have been implemented to improve and assure the quality of our products.

In case a product is found with a deficiency, e.g. a missing label, cracked vial or loose cap, please contact Pharming’s Qualified Person (QP) 24 hours a day via:

M: +31 (0)6 5332 1089

Or email at:

E: QA@pharming.com