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WG1 Quality

Minutes for the meeting 1 July 2024

Chair: Md. Harun-Or-Rashid (Bangladesh)

Members present in the meeting: Sarwat Jahan Pia (Bangladesh), Hamida Begum (Bangladesh), Sonam
Chophel (Bhutan), V. Rajappan (India), Atiek Supardiati (Indonesia), Dwi Damayanti (Indonesia), Aishath
Mohamed (on behalf of the member, Maldives), Saraswati Dangol (Nepal), Gowrie Kathriarachchi (Sri
Lanka), Boontarika Boonyapiwat (Thailand), Saiwarul Jadoonkittinan (Thailand), Saowalak Pomsuwan
(Thailand), Soraya Surasarang (Thailand), Delfim Costa Xavier Ferreira (on behalf of the member, Timor-
Leste).

Members absent: Amin Ngawang Tashi (Bhutan), BK Samantaray (India), Arum Prasetyaningtyas
(Indonesia), Dio Ramondrana (Indonesia), Helsy Pahlemy (Indonesia), Khairunnisaa’ Anindita (Indonesia),
Onne Widowaty (Indonesia), Sutanti Siti Namtini (Indonesia), Aishath Jaleela (Maldives), Sachita Joshi
(Nepal), K.A.P.S. Kuruppu (Sri Lanka), Paisan Pungjunan (Thailand), Piyamaporn Chantarasomchin
(Thailand), Crispin (Timor-Leste), Antonio Oqui (Timor-Leste)

SEARN Secretariat: Anil Chawla, Naina Sethi, Adrien Inoubli

Other participants: Representatives from SEARN Members and other organizations participating in the
meeting of the Assembly (please refer to the minutes of the Assembly), Pravin A Jagtap (India), Vivian
Rakuomi (MTaPS), Karen Loft (TGA), Natasha Brockwell (TGA), Angela N. Oliver (USP), Jeyakhandan E
(USP), Dhamari Naidoo (WHO)

Location: Virtual Meeting (the connexion information is shared by email)

Time Agenda item Lead


(Dhaka)
10:00 1 Introduction

1.1 Welcome Chair

1.2 Introduction of new members Chair / New members

The working group welcomed one new member:


• V. Rajappan (India)
• Helsy Pahlemy (Indonesia),
• Khairunnisaa’ Anindita (Indonesia),
• Onne Widowaty (Indonesia),
• Sutanti Siti Namtini (Indonesia),
• Piyamaporn Chantarasomchin (Thailand),

WG1 – Minutes of the meeting on 1 July 2024 Page 1 of 4


• Saowalak Pomsuwan (Thailand),
• Ms. Crispin (Timor-Leste)

The working group wished farewell to Mirawati Siregar (Indonesia) and Mrs Endang da Silva (Timor-
Leste) and expressed its gratitude for the contribution to SEARN.

1.3 Adoption of the Agenda Chair / Secretariat

The agenda was adopted unchanged.

1.4 Attendance to the working group Secretariat

The members were presented with the attendance in the working group since the start of the 2023-
2024 workplan.

10:15 2 Feedback from the Steering group Chair / Secretariat

The members were informed about the discussions held during the meeting of the Steering group.

10:20 3 Discussion and adoption of drafting groups’ outputs Chair / Secretariat

10:20 3.1 AP8: Improve the use and access to reference Bangladesh
standards
The WG adopted the proposed output, the recommended actions in the 2024-2025 workplan, and
agreed to its publication, including:
 the highlights from the Regional hybrid workshop on the optimal use of reference standards.

10:45 3.2 AP9: Strengthen collaboration between National Sri Lanka


Control Laboratories to develop capacity
The WG adopted the proposed output, the recommended actions in the 2024-2025 workplan, and
agreed to its publication, including:
 the template of a practical guide to testing in a country
The WG highlighted that the question of payment for hands on training still required to be further
discussed, and that payment from the participating NRAs may not be required in all situations.

11:10 3.3 AP14: Ensure the integrity of excipients Indonesia

The WG adopted the proposed output and agreed to its publication, including:
 the highlights from the Virtual workshop on testing methods for Ethylene glycol and
diethylene glycol in oral liquid medicines conducted on 17 and 18 October 2023
 the highlights form the engagement meeting with Industry conducted on 15 February 2024
 the highlights from the engagement meeting with Poison Centers conducted on 22 February
2024
 the recommendations to WHO, SEARN Members and the Assembly.

WG1 – Minutes of the meeting on 1 July 2024 Page 2 of 4


It was also agreed to conclude the dedicated action point, following up through action points ‘1
capacity building’, ‘3 information sharing’, ‘9 collaboration between NQCLs’, and the monitoring and
evaluation framework.

11:30 4 Discussion and adoption of the WG proposals in the Secretariat


2023-2024 Workplan, and of the proposed rapporteurs
and drafting group members
The WG adopted the following proposals for the 2024-2025 Workplan:

Action Lead Support


Need Action Rapporteur
Point WG WG
8 1 5 Improve the 1. Support the development and implementation Bangladesh
use and of a system to facilitate sharing and testing of WG1
access to samples between the SEARN NQCLs
reference 2. Support the finalisation and implementation of
standards the expansion of the composition of WG1 (as
needed) to support listing of suppliers of
references standards and, if needed, their
assessment
3. To develop a strategy to ensure alignment
between NQCL needs for primary reference
standards and certified reference materials
(CRM) and established regional and
international producers and pharmacopoeias,
collect and share information about official
reference standards access programmes, and
support convergence on the definitions of the
different categories of reference standards
4. To support Members in their risk-based
approaches through identifying minimum
standards for screening strategies
5. To further develop the strategy for biological
references standards
9 1 Strengthen 1. Develop an MoU to be signed during the next Sri Lanka
collaboration meeting of the Assembly WG1
between 2. Develop a sustainable training strategy (in
National coordination with AP1)
Quality 3. Develop and implement a database on the
Control capacity of SEARN NQCLs
Laboratories 4. Develop a Regional list of reference Quality
to develop Control Laboratories
capacity 5. Develop and pilot the system for collaborative
testing of samples (including draft bilateral
MoUs/contracts) and proficiency / inter
laboratory testing with EG/DEG
In addition, the working group proposed the following drafting group members to participate in the
following proposed action points led by other Working groups:

WG1 – Minutes of the meeting on 1 July 2024 Page 3 of 4


Drafting
Action Lead Support
Need group
Point WG WG
member
1 2 1345 Capacity building to support Members in achieving their Nepal WG1
objectives of Maturity Level using the Global Benchmarking
Tool and/or WLA status
3 4 1235 Facilitate information Sharing Bhutan WG1

5 2 134 Facilitate reliance Maldives


WG1
19 2 1345 Strengthen the capacity of SEARN Members to address Maldives
antimicrobial resistance (TBC) WG1

5 Monitoring and evaluation framework: adoption of the Secretariat


results and proposed changes
The WG adopted the results of the 2023-2024 exercise and the proposed changes in the Monitoring
and evaluation framework.

11:50 6 Any other business Secretariat


• Date of the next meetings
The WG agreed to organize the next meeting on Monday 7 October 2024.

12:00 7 Conclusion of the meeting Chair

The Chair concluded the meeting by appreciating the efforts from all members of the working group
and the secretariat.

WG1 – Minutes of the meeting on 1 July 2024 Page 4 of 4

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