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Consultative Workshop on Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods

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Consultative Workshop on Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods

National Regulatory Authorities are responsible to ensure that recalls are handled properly and promptly, including alerting the public, classifying the type of drug recall, and safely removing the affected product from the market. DRAP in collaboration with WHO, organized one-day consultative workshop on “Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods” held at DRAP Headquarter in Islamabad on 20th July, 2023. The workshop was aimed at ensuring strong communication skills and knowledge to effectively handle the SF threat and execution of recalls and rapid alerts. Government Analysts from all Quality Control Laboratories (QCLs) working under the DRAP Act 2012 and Drug Act 1976, as well and representatives from drug control administration of all federating units participated in the workshop.

The workshop focused on the following key objectives:

  1. Implementation of effective and integrated Recall and Rapid Alert system in Pakistan.
  2. Emphasizing the need and importance of Recall and Rapid Alert System.
  3. Training and building capacity of all the participants.
  4. Enhancing coordination and communication with provincial governments and related departments.
  5. Safe disposal system of SF products
  6. Improvement in DRAP’s guidelines and harmonization with International best practices.

Risk Communication flow chart for handling SF threats

Core Activities and Topics Covered

1. Introduction and Objectives of Workshop The day began with an overview of current system for rapid alerts and recalls for removing defective therapeutic goods from the market. Director Quality Assurance and Lab Testing, DRAP briefed the participants on the strategies designed to strengthen the collaboration among regulators and QCLs of all federating units. He emphasized the importance of timely and accurate communication to combat the challenge of SF therapeutic goods.

2. Overview of DRAP’s guidelines on Recalls and Rapid Alerts of Defective products This session explained the guidelines of DRAP and action response currently opted by DRAP, highlighting its strengths and limitations. Participants engaged in group discussions to evaluate which methods would be most effective in different scenarios.

3. WHO recommendation on Recalls and Rapid Alerts System in the benchmarking visit Participants were introduced to the WHO GBT indicators, sub-indicators and IDPs, WHO recent visit and their recommendation for the improvement of the current Rapid Alert system. The trainer comprehensively delivered the details, ensuring that the information provided is easily comprehensible and actionable.

4. Harmonization of Terminologies for Defective Products and Role of QCLs in Detection and Disposal of SF products This segment focused on the terminologies being used nationally and their harmonization with WHO recommended terminologies. Later the role of Quality Control Laboratories was emphasized and discussed in group discussion. 

5. Best practices for storage and disposal of SF products This session highlighted the current available practices and international practices as recommended by the WHO for safe storage and disposing of the SF products.

6.Effective communication among stakeholders for their removal from the market ;Recall is an effective means of protecting the public from a defective or potentially harmful product, and strong communication among relevant stakeholders is essential for the effective recall of SF Products. It was suggested to utilized modern communication channels by all federating units to ensure in time action on trigger information to safeguard public health. It was agreed by all the participants that prompt and effective communication is very crucial for implementing an proficient Rapid Alert and Recall System to removal of SF product from markets. 

7. Practical Exercises The afternoon session involved hands-on practical exercises. Participants were divided into groups and tasked with case studies for different hypothetical scenarios. Case studies and simulations illustrated the effective collaboration between all the relevant stakeholders. This interactive exercise encouraged teamwork and allowed attendees to apply the concepts learned throughout the day.

8. Concluding Remarks and Distribution of Certificates Director Pharmaceutical Evaluation & Registration (PE&R) concluded the workshop with his closing remarks on appreciating the active participation from all regulatory entities and QCLs across Pakistan. The certificates of participation were distributed among the participants at the end of session.  

DRAP and WHO collaborated to hold a “Two-Day Consultative Meeting on WHO AWaRe Classification of Antimicrobials in the National Essential Medicine List (NEML) of Pakistan”

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DRAP and WHO collaborated to hold a “Two-Day Consultative Meeting on WHO AWaRe Classification of Antimicrobials in the National Essential Medicine List (NEML) of Pakistan”

Access, Watch, and Reserve (AWaRe) classification was introduced by the World Health Organization in 2017 for strengthening antibiotic stewardship and controlling antimicrobial resistance at the national level. This also includes in WHO GPW 13 indicators of antibiotic use. AWaRe is a relatively “easy” tool that offers more than overall antibiotic use or more conventional classifications.

WHO country office, in Pakistan, has been facilitating the development of Pakistan’s first “Evidence-based AWaRE classification of essential antibiotics” online active engagement of stakeholders. In the past two years, national experts in the field and consultants were engaged on multiple occasions through online and face-to-face meetings to develop the needful tools, formulate a comprehensive desk review, and collect the indigenous AMR data with support of NIH. The first consultative meeting of the process was held on 29th April 2021 and was attended by more than twenty participants from federal, and provincial levels with representation from both public and private sector.

Drug Regulatory Authority of Pakistan in collaboration with Ministry of National Health Services, Regulation and Coordination convened the final consultative meeting for development of the AWaRe classification of antibiotics for Pakistan. The meeting participants included the representatives from the M/o NHSR&C, DRAP, World Health Organization, National Institute of Health, Healthcare Commissions and National AMR surveillance program leads at federal and provincial levels, and the AMR sentinel sites. Leading national experts from the field of microbiology, infectious diseases, and other specialties including pharmacists, nurses, academicians, and public health professionals and epidemiologists were invited to ensure maximum contribution from the stakeholders.

The developed list will act as a guiding principle for designing institutional antibiotic policies and act as a stepping stone to achieve control of the growing antimicrobial resistance in the country.

World Patient Safety Day: DRAP takes part in global health campaign on Medication Safety; NPC holds a Webinar on” Medication without Harm” on 16th September, 2022

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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 using Microsoft Team

Join a Microsoft Teams Meeting by ID | Microsoft Teams 
Meeting ID: 264 775 816 387 Passcode: J4tvFx

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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.

Asim Rauf, CEO DRAP represented Pakistan in the 2nd Meeting of the Heads of National Medicine Regulatory Authorities (NMRAs) of the Member States of the Organization of Islamic Cooperation, (OIC)

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Asim Rauf, CEO DRAP represented Pakistan in the 2nd Meeting of the Heads of National Medicine Regulatory Authorities (NMRAs) of the Member States of the Organization of Islamic Cooperation, (OIC)

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.

September, 06, 2022: The 2nd Meeting of Heads of National Medicine Regulatory Authorities (NMRAs) held on September 05-07, 2022 in Istanbul, Türkiye

Director General, Department of Drug Administration (DDA), Government of Nepal with a delegate visited DRAP HQ to foster mutual cooperation

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Director General, Department of Drug Administration (DDA), Government of Nepal with a delegate visited DRAP HQ to foster mutual cooperation

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.

DRAP and Islamia University of Bahawalpur (IUB) signed a Memorandum of Understanding (MoU) to promote scientific Collaboration

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DRAP and Islamia University of Bahawalpur (IUB) signed a Memorandum of Understanding (MoU) to promote scientific Collaboration

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.

Training Sessions on Regulatory Data Standards for Manufacturers at Karachi and Lahore

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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:

SrSession TitleDateNo. of Participant* (approx)
1Training on Regulatory Data Standards for Pharmaceutical Manufacturers19th August 2022 at Karachi.30
2 Training on Regulatory Data Standards for Pharmaceutical Manufacturers 22nd August 2022 at Lahore.30

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.

Join using Microsoft Team

Join a Microsoft Teams Meeting by ID | Microsoft Teams 
Meeting ID: 251 494 560 025 Passcode: p2MTFn

Time: 10:00 AM to 03:30 PM  

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-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.

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Training on Pharmacovigilance Module (AEFI/PV) in the Pakistan Integrated Regulatory Information Management System (PIRIMS)

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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.

Bob Tribe, TGAs former GMP Chief, assists DRAP for Strengthening of Inspection System towards harmonized PIC/s GMP Standards

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Bob Tribe, TGAs former GMP Chief, assists DRAP for Strengthening of Inspection System towards harmonized PIC/s GMP Standards

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.