Everyone welcome to the channel pharma focus. I hope you guys are doing really great and I'm back with another video. This time the video is about the SEOs form which is used in pharmarmacco vigilance.
So this form is a standardized international form and it is used to report the adverse drug reactions to the regulatory authorities and this form is being used by the pharmaceutical companies, health authorities so as to collect and share the essential information about an adverse event in a consistent format. And if we talk about the history of Seon's firm then it was developed in 1980s and in collaboration with WH it was developed. So the major goal was to harmonize the global drug safety reporting and to simplify the communication between pharmaceutical companies and health authorities.
So it is the foundation for the modern pharmacco vigilant systems that we use today. uh if I talk about the role of SEO's form uh in PV then it is very obvious that it is for the development of international guidelines and apart from that there is a harmonization of pharmacco vigilance practices with the soms form in place and then we have the creation of standard uh terminology and standard formats so introduced the standardized format s like SEO's fun form which was widely used for the expedited adverse drug reaction reporting. Then next up we have it uh facilitates the collaboration that is it acts as a bridge uh between the regulatory authorities, industries, academia and who it ensures that the PV policies they are scientifically sound and they are globally applicable.
So if we talk about um the other things then going forward uh we'll be looking at the SEOs form how it look like and what information is exactly entered into a SOM's form. All right. So heading on to the SOS form.
So this is the website where you can download the yoms form and this yams form links with ICH E2B R2 and R3 guidelines and it can be downloaded here. So as you click on this then you get the COMs form. So, COPS form is the suspect adverse reaction report as it is already stated here.
And if we talk about uh the sections that are listed uh here, then it includes the reaction information wherein uh particularly you're going to put the patient initials, the country, the date of birth, age, sex, reaction onset and describe the reaction. So including any kind of relevant test or lab data and apart from that we have a section here which is very critical and because this uh particular section leads to the case if it is a serious adverse reaction in any cases if these of the parameters qualify for the reaction you're reporting those are selected here. Apart from that we have a section of suspect drug information which is um basically going to be the company drug and the drug which we suspect that is responsible behind any kind of adverse reaction.
[sighs] So we need to capture it here. The daily dose, root of administration, indication for use for what purpose you were taking that drug, the therapy dates from and to and the therapy duration. So this is particularly is an editable form and you can edit it here save it and then further process it.
So if we talk about the reaction abate after stopping the drug and the reaction reappear uh after reintroduction of the drug then these particular sections are the section number 20 that is abate after stopping drug refers to the D challenge and if we talk about section number 21 then it is about the rechallenge of the suspect drug. Apart from that we have a section for conccommittant drug and history which is this section where you need to capture any kind of conccommittant drugs that you were taking at the time you were having uh that suspect drug [snorts] and any kind of other relevant history which may include the diagnostics, allergies, pregnancy with the last month of period etc. you need to capture it here.
Then we have the manufacturer information number uh section. So this is the name and address of manufacturer and whatever details you are having you need to capture it here. Apart from that uh this is about what kind of fields in this form are R2 fields and what are the R3 fields.
So that's all for the SEOs form. All right. So this is the example of um health Canada website where you can find the SOM's form.
So the basic thing here is that whenever you're looking for a SEOs form, you need to look for it for somewhere where there is a credible source. So this is mandatory adverse reaction reporting form for the industry and these reports must be made within 15 calendar days of receiving or becoming aware of the information of adverse reaction and this is where you need to submit the report. So this will again redirect you to the soms one form uh where you can download it and you can enter the details as I stated earlier.
So that's all for the video related to Soms. I hope you guys like it. If you have any questions, do drop it in the comment section.
And yeah, keep watching, keep growing. Thank you.
