i taked a mail from MHRA. everyone taked this ? Mail:
Dear Contributor,
Thank you for previously registering to receive notifications about the [review] of psychiatric and sexual side effects suspected to be associated with isotretinoin, which is being carried out by the Commission on Human Medicines (CHM).
The CHM’s Isotretinoin Expert Working Group (IEWG) is carefully considering all of the available information and thanks everyone who has already provided contributions to the review.
To aid the assessment of these important issues, the IEWG would like to hear directly from patients and other stakeholders on the following questions:
- Based on your experience of isotretinoin, what aspect of treatment has had the greatest impact (positive or negative)?
- How should the risks associated with isotretinoin be managed?
The IEWG is holding a meeting on Friday, 16 July 2021 and inviting patients and other stakeholders to attend and present their answers to these questions. Due to the current pandemic this meeting will be held virtually.
The purpose of this meeting is for the IEWG to hear any additional information directly from patients and stakeholders that has not already provided through the consultation or reported to our Yellow Card scheme.
You can register your interest in presenting at this meeting using this link. The deadline for registering is on Thursday, 17 June 2021.
We want to ensure as many people as possible can contribute so the IEWG hears the full range of views in the time available, so each person will be able to speak for up to 5 minutes.
Please note that it may not be possible to invite all those who express an interest in speaking to the IEWG, we will aim to cover the range of stakeholders who have indicated they wish to speak to the IEWG, and represent the positive, negative and neutral opinions in a balanced way.
Everyone who registers will receive a response by 30 June 2021, confirming whether or not they are invited to speak. If invited, you can stay for the whole meeting or leave at any time after your contribution.
Before presenting at the IEWG, we will contact you and offer you a preparatory meeting to explain more about how the IEWG meeting will operate and the Zoom meeting functions that will be used. The preparatory meetings will be held on Monday, 5 and Thursday, 8 July 2021. When you register you will be asked to indicate your preference. You only need to attend one preparatory meeting if selected to speak.
Attendance at the IEWG meeting will be by invitation only. However, the meeting will be recorded and subsequently published by the MHRA.
All attendees will be asked to confirm their consent to be recorded and will be able to specify their preferences regarding how their name is presented and whether or not they appear on camera. Consent will be verified before and after the meeting and agreed position reflected in the published recording. The final recording may be edited to respect the privacy preferences of the participants.
Patient and other stakeholder views are an essential part of this review of isotretinoin. If you are not able to present to the IEWG in this instance and you have additional new information you wish to share with them, please email us at MHRACustomerServices@mhra.gov.uk by Friday, 16 July 2021.
Kind regards,
Patient, Public and Stakeholder Engagement team
The Medicines and Healthcare products Regulatory Agency