Drug Regulatory Authority Of Pakistan CEO Claims Patient Safety Among Its Top Priority

Chief Executive Officer (CEO), Drug Regulatory Authority of Pakistan (DRAP), Sheikh Akhter Hussain here on Tuesday said patient safety is its top priority hence stringent approach has been adopted for registration of medical products and their administration as well as application.

KARACHI, (UrduPoint / Pakistan Point News - 25th Sep, 2018 ) :Chief Executive Officer (CEO), Drug Regulatory Authority of Pakistan (DRAP), Sheikh Akhter Hussain here on Tuesday said patient safety is its top priority hence stringent approach has been adopted for registration of medical products and their administration as well as application.

Addressing a day-long workshop "Pharmacovigilance: Monitoring Product Safety to Protect Patients," organized by Sanofi in collaboration with DRAP, he said Pharmacovigilance is critical to patients' safety.

It was mentioned on the occasion that WHO itself defines pharmacovigilance (PV) as the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem.

Sheikh Akhter Hussain was appreciative of the session said PV is an important component of medicine safety system and DRAP is keen to turn functional a central Pharmacovigilance center in close coordination with the provinces.

He said series of steps have been taken to make the PV system in Pakistan highly effective with major focus on adverse drug reaction reporting, signal detection and data sharing with all stakeholders after due assessment of the reported drug safety cases.

DRAP was said to have already initiated the process of PV capacity building and some strategic steps taken in this context include Associate membership of WHO Uppsala Monitoring Centre, Subscription of Vigiflow system, Deployment of IRIMS system for reporting adverse drug reactions report.

The workshop was conducted by Anton Klishin (Multi-Country Safety Head, Sanofi Global Pharmacovigilance), a subject specialist, associated with the field of pharmacovigilance since 2012.

Highlighting objective of the workshop, he said it was to share global practices on patient safety with an overview on Good Vigilance Practice (GVPs), Safety Reporting in Clinical Research, Periodic Benefit Risk Report and Signal Management.

Dr. Asim Jamal, Country Chair and General Manager of Sanofi Pakistan in his presentation mentioned Sanofi to have a strong Global/Local Pharmacovigilance & Epidemiology (GPE) Department that collects pharmacovigilance data from all sources of information worldwide in a passive and an active manner.

The effectiveness of our patient data collection model depends on strong interactions with all stakeholders, he said mentioning that the organization was committed to complying with data privacy protection rules, which apply from the step of data collection to the use of data for strictly medical and scientific purposes to protect the public health.

Shaikh Faqeer Muhammad, Director Pharmacy Services of DRAP and senior medical practitioners as well as pharmacologists were alsopresent on the occasion.