Introduction

Pharmacovigilance (PV) is defined by the World Health Organisation (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Monitoring the safety of medicines includes all activities related to the detection, assessment, understanding and prevention of adverse effects and other possible drug-related problems. This monitoring is carried out in a number of ways, including review and evaluation of suspected adverse reaction reports, published literature, epidemiological studies and additional clinical trial results.

Julphar continually assesses new and emerging safety data as it becomes available and undertakes regulatory action as appropriate. In addition to contributing to the safety profiles of existing drugs, pharmacovigilance activities help to improve the knowledge set and contribute to the breadth of epidemiological data.

Pharmacovigilance is therefore vital for the advancement of medical understanding, future research and product development. Any improvements in safety or understanding will ultimately lead to improvements in patient care.

Julphar’s Responsibility

Julphar is responsible for reporting suspected adverse reactions to the authorities of each country for medical products received from Health Care Professionals (HCP) (including but not limited to medical doctors, pharmacists, nurses, dentists, allied health professionals, midwives, caregivers etc.).
 
All queries and product related complaints are taken very seriously and treated with the strictest confidentiality. All employees of Julphar participating in the pharmacovigilance activities are trained, know their responsibility and are able to execute their duties.
 
As per Julphar policy, all employees are required to report any issues relating to the safety or quality of our medicines immediately. All spontaneous adverse events of marketed products are collected via phone, email, fax or post. All adverse events of investigational products are collected as per the Clinical Trial Protocol via above mentioned means.