17th September has been declared as the World Patient Safety Day, to raise awareness about Global Patient Safety Challenges with a specific theme each year. One of the basic component of patient safety is putting an end to avoidable errors within healthcare settings.
WHO has identified “Medication Without Harm” as the theme for 2022 which is the third Global Patient Safety Challenge. This campaign is aimed to propose solutions to remove the obstacles prevalent today to ensure the safety of medication practices. The objective and voice “Medication Without Harm” aims to reduce avoidable medication-related severe harms by 50% globally in the next five years. Over the years, The challenge to ensure patient safety become more complex with new technology, treatments, and medicines being introduced in healthcare systems.
DRAP invites all healthcare professionals to work together to improve patient safety and ensure use of medications without harm
How to Join Our Webinar
The National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan has scheduled an online session on 16th of September, 2022. This session is the part of the our campaign on the World Patient Safety Day 2022 with a focus on theme “Medication Without Harm”.
Topic: Medication without Harm
Date and Time: Friday 16, September, 2022 at 10:00 AM to 11:00 AM
Join virtually using Microsoft team preferably 15 minutes before the start of session. Participants are advised to display their names and organization 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.
-Sessions recordings and Training Materials will be available shortly after the session.
DRAP celebrated World Patient Safety Day 2022
The National Pharmacovigilance Centre, Division of Pharmacy Services, DRAP conducted an online session on the “Medication Without Harm” campaign of the World Patient Safety Day 2022. The target audience were healthcare professionals. The topics of Medication errors in context of healthcare institutes and medication safety & role of DRAP in the perspective of patient safety and pharmacovigilance were focused on in the session. Mst. Saharish Nazar, Agha Khan University Hospital (AKHU) and Mr. Abdul Mateen Focal Person National Pharmacovigilance Centre were the speakers in the session.
Dr. Noor Muhammad Shah, Head of National Pharmacovigilance Centre gave the message that patient safety is a mutual responsibility and presence of a reporting and learning system is essential. Muhammad Asad, Depuy Director Pharmacy Services conveyed the global scenario of harm caused due to medication and the importance of patient safety in provision of healthcare.
The session ended with the expectation of a positive impact on the working and output of pharmacovigilance in the country.
The Second meeting of Heads of National Medicine Regulatory Authorities (NMRAs) held on September 05-07, 2022 in Istanbul, Türkiye. Mr. Asim Rauf, CEO DRAP and Dr. Obaidullah, Director, DRAP represented Pakistan in the meeting.
More than 40 member states participated in the meeting and adopted OIC Action Plan to promote collaboration among OIC NMRAs for access to safe, effective and quality medicines and vaccines in OIC Member States, 2022-2024.
The Action Plan includes eight objectives, among others, to strengthen cooperation and networking among NMRAs in OIC Member States, to develop the capacity of human resources and to establish and strengthen regional and sub-regional harmonization and networking among OIC countries.
The Meeting also adopted Istanbul Declaration, which included the recognizing of the challenges posed by the COVID-19 pandemic.
An official delegate from Department of Drug Administration (DDA), Ministry of Health & Population, Government of Nepal under the leadership of Mr. Bharat Bhattarai, Director General, DDA visited DRAP HQ, Islamabad on Tuesday, August 23, 2022. Mr. Asim Rauf, CEO DRAP warmly welcomed the Mr. Bhattarai and other senior officials from DDA and MoH, Nepal.
Directors of Division of Pharmaceutical Evaluation & Regisatrion (PE&R), Medical Devices and Medicated Cosmetics (MDMC), and Health & OTC Products (H&OTC) demonstrated their respective presentations on the various regulatory functions of DRAP. The delegates shows keen interest in the journey of Pakistan toward successful implementation of WHO/ICH Common Technical Document (CTD) format for registration of pharmaceutical and biological drugs in Pakistan, and praises the IT Systems establish by DRAP for integrated regulatory data management in the country.
The officials of the international Health Partner, United States Pharmacopeia- Prompting Quality of Medicine Plus, from Nepal and Pakistan, were also present in these meetings.
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.