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20, AVENUE APPIA – CH-1211 GENEVA 27 – SWITZERLAND – TEL CENTRAL +41 22 791 2111 – FAX CENTRAL +41 22 791 3111 – WWW.WHO.INT Ref.: C.L.36.2024 The Director-General of the World Health Organization (WHO) presents his compliments to Member States and regional economic integration organizations, and has the honour to inform them that in accordance with resolution WHA65.19 (2012), establishing a Member State mechanism on substandard and falsified (SF) medical products, the thirteenth meeting of the mechanism will take place from 20 to 22 November 2024, virtually and in Geneva, Switzerland. The meeting will be held in a hybrid format and will open at 10:00 (CET) on Wednesday, 20 November 2024. The working hours will be 10:00–12:30 (CET) and 14:00–16:00 (CET) each day. In order to participate, delegations are requested to register for the meeting in the INDICO registration system using the following link: https://indico.un.org/e/13thMSM_November2024. The INDICO registration system has a two-step authentication process requiring users to enter more than the conventional password to gain access to the system securely. Users will be asked to enter a password and verify their identity through a verification link in an email sent to the email address/user ID provided at login. Member States are encouraged to include in their delegations members with expertise in national health and medical products regulatory matters. Registration includes submitting in INDICO a copy of the credential with the composition of the respective delegation, with details as follows: • The credentials should be in the form of a note verbale or letter and be issued by the Head of State, the Minister for Foreign Affairs, the Minister of Health, or any other appropriate authority, i.e. Permanent Missions and senior government officials, such as Directors-General for Health. • Member States will be represented at the thirteenth meeting by not more than two delegates in person. (Due to space restrictions, each delegation may have two persons physically present in the meeting room at WHO headquarters in Geneva, Switzerland). • Credentials should include the following information for each participant: LAST NAME (in capital letters), first name, title, function, institution, city, gender (unless indicated in title). • The credentials should clearly indicate the delegates (up to two) registering to attend the meeting in person and/or delegates participating virtually (no limit on numbers). • Registrations without credentials cannot be approved.  Page 2 C.L.36.2024 Registration will be open from 16 August 2024 and should be completed no later than 11 November 2024. In case of questions related to registration, an email can be sent to: [email protected]. All registered delegates will receive a personalized Zoom link to access the virtual platform. Documentation for the Member State mechanism meeting will be available at the following link: https://apps.who.int/gb/SF/ as soon as available in all six official languages. There will be an opportunity for Member States to test their connections on Monday, 18 November using the same personalized Zoom link sent to them for the thirteenth meeting. The Steering Committee of the Member State mechanism will meet on Tuesday, 19 November 2024. Member States will have the opportunity to observe the meeting of the Steering Committee through electronic means. The instructions for registration and link to the session will be sent in advance of the meeting. This will be a different link to the one provided for the thirteenth meeting of the mechanism. On the margins of the Steering Committee and mechanism meetings, five informal technical meetings are being organized as side events. These will be hybrid meetings and one Zoom link will be provided for the five sessions. Registration for a Zoom link for these sessions can be made in advance at the following link: https://who.zoom.us/meeting/register/tJwoc--vrDgqHtccF6GMN7QKGL1HahvG6858. These informal technical meetings will cover: 1. Unpacking the WHO Member State mechanism on substandard and falsified medical products: ensure the audience gains a comprehensive understanding of what the mechanism is, how and why it started, the scope and objectives – Friday, 15 November from 12:30 to 14:00. This will be an online meeting and open to all Member States. 2. Improve Member States’ understanding and uptake of technologies to screen and detect substandard and falsified medical products (presentations and discussions on technology development and use). This topic is linked to Activity C – Tuesday, 19 November from 14:00 to 15:00. This will be a hybrid meeting and open to all Member States. 3. Effective risk communication and awareness strategies for tackling substandard and falsified medical products: case studies from Member States. This topic is linked to Activity E – Tuesday, 19 November from 15:30 to 16:30. This will be a hybrid meeting and open to all Member States.  Page 3 C.L.36.2024 4. Detecting and assessing websites suspected of advertising/supplying substandard and falsified medical products: demonstration of tools to automate and triage websites for review by regulators. This topic is linked to Activity G – Wednesday, 20 November from 16:30 to 17:30. This will be a hybrid meeting and open to all Member States. 5. How Member States respond to substandard and falsified medical products in informal markets. This topic is linked to Activity H – Thursday, 21 November from 16:30 to 17:30. This will be a hybrid meeting and open to all Member States. In the event that any limitations to physical meetings would preclude in-person participation, a decision to adjust the meeting modalities would be taken and communicated to Member States. For ease of reference, the schedule can be found below. Date Time – indicated is Meeting Information Central European Time (CET) Unpacking the WHO Online meeting – Zoom Friday Member State mechanism on link 12:30–14:00 15 November substandard and falsified medical products 10:00–12:00 Member States may test Monday their connections using Test session 18 November the Zoom link sent to 14:00–16:00 them. Steering Committee Steering Committee of the members only; Member 10:00–12:30 Member State mechanism States may observe the meeting virtually. Informal technical meeting on improving Member States’ understanding and Room – Auditorium 14:00–15:00 uptake of technologies to Z1/Z2/Z3 screen and detect Tuesday substandard and falsified 19 November medical products Informal technical meeting on effective risk communication and awareness strategies for Room – Auditorium 15:30–16:30 tackling substandard and Z1/Z2/Z3 falsified medical products: case studies from Member States  Page 4 C.L.36.2024 Date Time – indicated is Meeting Information Central European Time (CET) 10:00–12:30 Thirteenth meeting of the Room – Auditorium Member State mechanism Z1/Z2/Z3 14:00–16:00 Informal technical meeting Wednesday on detecting and assessing 20 November websites suspected of advertising/supplying Room – Auditorium 16:30–17:30 substandard and falsified Z1/Z2/Z3 medical products: demonstration of tools to automate and triage websites for review by regulators 10:00–12:30 Thirteenth meeting of the Room – Auditorium Member State mechanism Z1/Z2/Z3 14:00–16:00 Thursday 21 November Informal technical meeting on how Member States Room – Auditorium 16:30–17:30 respond to substandard and Z1/Z2/Z3 falsified medical products in informal markets 10:00–12:30 Friday Thirteenth meeting of the Room – Auditorium 22 November Member State mechanism Z1/Z2/Z3 14:00–16:00 The Code of Conduct to prevent harassment, including sexual harassment at WHO events, is available at the following link: Code of Conduct to prevent harassment, including sexual harassment, at WHO events. The Director-General of the World Health Organization takes this opportunity to renew to Member States and regional economic integration organizations, the assurance of his highest consideration. GENEVA, 13 August 2024 Saatja: [email protected] Teema: C.L.36.2024 (13th meeting of SF medical products) Kuupäev: 2024-08-13 14:39 Dear Member States of the World Health Organization, Please find attached, in the six official languages, C.L.36.2024 regarding the thirteenth meeting of the Member State mechanism on substandard and falsified (SF) medical products which will be hel from 20 to 22 November 2024. Should you have questions regarding C.L.36.2024 please send an email to <mailto:[email protected].> [email protected]. Best regards, Department of Governing Bodies World Health Organization