The Drug Regulatory Authority of Pakistan (DRAP) and Islamia University of Bahawalpur (IUB) undergoes in a Memorandum of Understanding on August 19, 2022. A brief ceremony was organized at DRAP HQ, Islamabad where Mr. Asim Rauf, CEO, DRAP and Dr. Athar Mahboob, Vice Chancellor, IUB signed the MoU on behalf of their respective institutions. Senior members of both organizations were also present on this occasion.
Both organizations, Under this MoU has agreed to facilitate cooperation in academic research to fosters collective efforts in facilitating scientific progress through exchange of knowledge and expertise. It will open new opportunities for academic, research, trainings and mutual collaborations.
Regulatory Data standard help Regulatory Authorities and Pharmaceutical Manufacturers for efficient exchange of regulatory data which ultimately reduces the processing time by avoiding clarifications due to variation in terminologies. These standards also facilitate data sharing between regulators and manufacturers in better understandable way, through both manual and electronic means, in a harmonized and consistent manner that is interoperable across the globe.
DRAP, in collaboration with United States Pharmacopeia, Promoting the Quality of Medicines Plus Program, is organizing a series of training sessions for regulators and industry on the regulatory data standards .The details of sessions are:
No. of Participant* (approx)
Training on Regulatory Data Standards for Pharmaceutical Manufacturers
19th August 2022 at Karachi.
Training on Regulatory Data Standards for Pharmaceutical Manufacturers
22nd August 2022 at Lahore.
Stakeholder associations (i.e Pakistan Pharmaceutical Association (PPMA), and Pharma Bureau) are requested to share nominations of technical and regulatory workforce for each training by 16th August 2022 positively. Nominated person can register themselves free of cost by filling out the following registration form at the earliest.
*Please note that :-
Registration will be granted on first come first serve basis. only one participant from each manufacturer can join the session onsite. After the completion of first 30 registration for onsite participation for each session, virtual link will be provided to the remaining registrants.
Registrations are closed now.
How to join Session Virtually:-
Those participants who submitted registration forms for the training sessions can join virtually using Microsoft team. Virtual participants are requested to join 15 minutes before the start of session, and advised to display their Names and Organizations while joining the session. Please keep your mic and camera off after joining the session. If you wish to ask a question from the presenter, please click the icon to show raise hand, and turn your mic and camera on while asking a question from the presenter.
-Sessions recordings and Training Materials will be available shortly after the session. -E-Certificate will be issued to training participants after completion of feedback survey form that will be sent to them via email.
Drug Regulatory Authority of Pakistan (DRAP), in collaboration with the United States Pharmacopoeia (USP), Promoting Quality of Medicine Plus Program, Pakistan, conducted a one-day pharmacovigilance training session for the staff of the National Pharmacovigilance Centre on the newly introduced Pharmacovigilance (PV) Module in Pakistan Integrated Regulatory Information Management System (PIRMIS) on the 29th of July, 2022.
Dr Noor Muhammad Shah, Director of Division of Pharmacy Services (Head of National Pharmacovigilance Centre) along with his team of Additional Director, Deputy Director and Assistant Directors, Pharmacovigilance Centres, Division of Pharmacy Services participated in the training session. A team of USP facilitated the training session and the technical input and training was conducted by Mr Tayyab, PIRIMS Consultant-PQM+. The PIRMIS management system facilitates the submission of data by the registration holders and would be helpful in the quick disposal of work. The new PV Module has been introduced in the PRIMIS to facilitate the submission of pharmacovigilance data by registration holders as per Pharmacovigilance Rules, 2022.
DRAP aims at harmonization of Inspection system and procedures in the field of Good Manufacturing Practices (GMP) for drugs, and quality system for inspectorate, comparable with the best international regulatory practices. In this regard, Mr. Robert Wayne Tribe, TGAs former GMP Chief is providing Consultation to DRAP for progress toward PIC/s membership.
Mr. Bob served as Chief GMP at the Australian TGA for 23 years, has a hand in creating many of the GMP requirements. He is regarded as true GMP expert and consults to many GMP regulators around the world, assisting them reach the PIC/S level of regulatory control. Bob’s also served as Deputy Chairman of the PIC/S during 1998-1999, followed by a tenure as Chairman of PIC/S from 2000-2001. During his recent visit in Pakistan, he conducted observed GMP Audit and various consultative sessions with the regulators, Inspectors, industry and senior management of DRAP to discuss the current level of GMP Inspection System and is advising on gap assessment of inspectorate system to be harmonized with the PIC/s GMP Standards. A training session was also organized for DRAP’s staff on PIC/s background information for the Applicant Authorities, PIC/s GMP requirements and inspection approach.
CEO, DRAP highly appreciated the efforts of Mr. Bob for extending his services to DRAP to further strengthening and harmonization of inspection system of Pakistan at par with the PIC/s Standards. DRAP is fully committed to undertake all measures to ensure consistent supply of standards quality therapeutic goods for the people of Pakistan.
Am interactive session on healthcare research, ethical practices and collaborative role of academia and regulators was arranged at DRAP HQ, Islamabad on 26th July, 2022. A renown academician, Prof.Dr. Zaheer ud din Babar, Professor in Medicines and Healthcare, Department of Pharmacy, School of Applied Sciences, Director, Pharmaceutical Policy and Practice Research Centre, University of Huddersfield, presented his expert views on the topic and led various discussions with regulators.
The ISPE Annual Conference & Exhibition, 2022 for Pharmaceutical and biomanufacturing professionals is happening from 17-19 August, 2022 at Suntec, Singapore. This conference is aimed at highlighting global and regional best practices in process, technology and innovations. International and Asian manufacturers, regulatory agencies and subject matter experts share knowledge from manufacturing facility design to finished product.
The exhibition is known as showcasing latest technologies and services, workshops and discussion sessions. This year, participants can join the conference both in-person or virtually.
Free Registration for Inspectors, Pharma and Biomanufacturers form Pakistan
The organizers of ISPE Conference and Exhibition, 2022 have offered free registration for inspectors and all industry people from Pakistan who can get register for free to attend the ISPE Singapore conference in august, either online or in person.
Interested applicants are required to fill out the google form provided on the this link or by open below link in the browser:- https://docs.google.com/forms/d/e/1FAIpQLSdoBS_9feTiQZG_921XB1t1cZTn2uDAUj7lfX5C44uFzRIDrQ/viewform?usp=sf_link. Please type in ‘ISPE’ in the first question field. The organizers will help them to issue the complimentary passes.
National Pharmacovigilance Centre (NPC), Drug Regulatory Authority of Pakistan (DRAP) in collaboration with Holy Family Hospital, Rawalpindi Medical University conducted a one-day pharmacovigilance training session on 20th July, 2022 at Rawalpendi Medical University for Clinical Pharmacy and Pharmacovigilance Officers and Hospital Pharmacists of the public sector hospitals of the Rawalpindi Division.
Dr Noor Muhammad Shah, Director Division of Pharmacy Services (Head of National Pharmacovigelance Centre), Mr. Abdul Mateen, Assistant Director Pharmacy Services (Focal Person National Pharmacovigilance Centre), Mst. Aqsa Hashmi, Assistant Director Pharmacy Services and Mst. Nazima Asghar, Clinical Pharmacy and Pharmacovigilance Officer, Holy Family Hospital gave detailed presentations in the subject matter.
Medical Superintendent and Drugs Controller of Holy Family Hospital and Professor/HOD of Pharmacology Department along with her team from Rawalpindi Medical University also joined the session. Participants from Holy Family Hospital, Rawalpindi Institute of Cardiology, Benazir Buttto Hospital, Rawalpindi Institute of Urology and Transplant and Tehsil Headquarters hospitals of Murree, Taxila, Gujar Khan, Kallar Syedan, Kotli Sattian were trained by the above team of trainers from DRAP and Holy Family Hospital on different aspects of pharmacovigilance such as the establishment of pharmacovigilance centre, collection of data and subsequent reporting to the provincial pharmacovigilance centre of the Punjab. The training was concluded by the Head of the National Pharmacovigilance Center by highlighting the imminent points of the presentations with the hope that the session will bring significant improvement for establishment of Pharmacovigilance Centers and reporting of ADRs accordingly.
DRAP, in collaboration with Health Partner Organization United States Pharmacopeia, Promoting Quality of Medicines Plus, organizes a training workshop for regulatory staff to strengthen implementation of Strategic plan through regulatory functions KPI based performance measurement system.
National Pharmacovigilance Centre (NPC), Drug Regulatory Authority of Pakistan (DRAP) in collaboration with Islamabad Pharmacovigilance Centre and Shifa International Hospital, Islamabad conducted a one-day pharmacovigilance training session on 19th of May, 2022. Director and Deputy Director Pharmacy Services Division, Team Lead Vigilance and Focal Persons of National Pharmacovigilance Centre and Islamabad Pharmacovigilance Centre attended the training session.
Pharmacovigilance focal persons of public and private sector hospitals of Islamabad were trained on ADRs reporting as per Pharmacovigilance Rules, 2022. Hands-on training on collecting and filling in ADRs reporting forms and subsequent causality assessment was provided to the participants. The training was concluded with the hope of arranging further such sessions in the future.
Mr. Asim Rauf, CEO DRAP met with WHO Country Representative for Pakistan, Dr Palitha Gunarathna Mahipala on Monday 25th April, 2022 at WHO Country Office, Islamabad, to discuss the bilateral cooperation among WHO and Drug Regulatory Authority of Pakistan.
Dr. Mahipala appreciated the efforts of DRAP and Ministry of National Health Services, Regulation & Coordination for strengthening the national regulatory framework to ensure and enhance the access of quality assured, safe and efficacious therapeutic goods in the country for better health of the people of Pakistan. Mr. Asim Rauf, acknowledged the role of WHO and country office’ team for extending assistance in various health programs which are improving the access of Pakistani citizen to quality assured therapeutic goods.
The meeting ended with the reiteration of the commitment from WHO and DRAP for strengthening the bilateral cooperation and to take all possible measure for protecting the health of the people of Pakistan.