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Pharmaoffer Cookie Policy

 

 

Pharmaoffer uses cookies and similar technologies to help provide, protect, and improve the Pharmaoffer Platform. This policy explains how and why we use these technologies and the choices you have.
A cookie is a small data file that is transferred to your device (e.g. your phone or your computer). For example, a cookie could allow us to recognize your browser, while another could store your preferences. There are two types of cookies used on the Pharmaoffer Platform: (1) “session cookies” and (2) “persistent cookies.” Session cookies normally expire when you close your browser, while persistent cookies remain on your device after you close your browser, and can be used again the next time you access the Pharmaoffer Platform.
We also use other technologies with similar functionality to cookies, such as web beacons, pixels, mobile identifiers, and tracking URLs, to obtain Log Data (as described in the Privacy Policy). For example, our email messages may contain web beacons and tracking URLs to determine whether you have opened a certain message or accessed a certain link.

 

 

Why Pharmaoffer Uses These Technologies

We use these technologies for a number of purposes, such as:

  • To enable you to use and access the Pharmaoffer Platform and the Payment Services.
  • To enable, facilitate and streamline the functioning of and your access to the Pharmaoffer Platform.
  • To better understand how you navigate through and interact with the Pharmaoffer Platform and to improve the Pharmaoffer Platform.
  • To serve you tailored advertising (such as on the Pharmaoffer Platform, emails and on third-party websites).
  • To show you content (e.g., advertisements) that is more relevant to you.
  • To monitor and analyze the performance, operation, and effectiveness of the Pharmaoffer Platform and Pharmaoffer advertisements.
  • To enforce legal agreements that govern use of the Pharmaoffer Platform.
  • For fraud detection and prevention, trust and safety, and investigations.
  • For purposes of our own customer support, analytics, research, product development, and regulatory compliance.


Cookies

When you visit our websites we place cookies on your computer. Cookies are small text files that websites send to your computer or other Internet-connected device to uniquely identify your browser or to store information or settings in your browser. Cookies allow us to recognize you when you return. They also help us provide a customized experience and can enable us to detect certain kinds of fraud. In many cases you can manage cookie preferences and opt-out of having cookies and other data collection technologies used by adjusting the settings on your browser. All browsers are different so visit the “help” section of your browser when to learn about cookie preferences and other privacy settings that may be available. Please note that if you choose to remove or reject cookies or clear local storage this could affect the features, availability, and functionality of our websites.

Pixel Tags and Web Beacons

Pixel tags and web beacons are tiny graphic images and small blocks of code placed on website pages, ads, or in our emails that allow us to determine whether you performed a specific action. When you access these pages, or when you open an email, the pixel tags and web beacons let us know you have accessed the web page or opened the email. These tools help us measure response to our communications and improve our web pages and promotions.

Server Logs and Other Technologies

We collect many different types of information from server logs and other technologies. For example, we collect information about the device you use to access our website, your operating system type, browser type, domain, and other system settings, as well as the language your system uses and the country and time zone where your device is located. Our server logs also record the IP address of the device you use to connect to the Internet. An IP address is a unique identifier that devices require to identify and communicate with each other on the Internet. We may also collect information about the website you were visiting before you came to our website and the website you visit after you leave our site. These tools help us improve user experience and deliver our services.

Device Information

We may use device-related information to authenticate users. For example, we may use your IP address, browser information, or other data provided by your browser or device to identify the device being used to access our platform. We may also use these device-related techniques for associating you with different devices that you may use to access our content including for fraud-protection purposes and to better target advertising.

Third Parties

We may also allow certain business partners to place these technologies on the Pharmaoffer Platform. These partners use these technologies to (1) help us analyze how you use the Pharmaoffer Platform, such as by noting the third party services from which you arrived, (2) market and advertise Pharmaoffer services to you on the Pharmaoffer Platform and third-party websites, (3) help us detect or prevent fraud or conduct risk assessments, or (4) collect information about your activities on the Pharmaoffer Platform, other sites, and/or the ads you have clicked on.
For example, to help us better understand how people use the Pharmaoffer Platform, we work with a number of analytics partners, including Google Analytics. To prevent Google Analytics from using your information for analytics, you may install the Google Analytics Opt-Out Browser by clicking here.
Third parties may also use such tracking technologies to serve ads that they believe are most likely to be of interest to you and measure the effectiveness of their ads both on the Pharmaoffer Platform and on other websites and online services. Targeting and advertising cookies we use may include Google, and other advertising networks and services we use from time to time. For more information about targeting and advertising cookies and how you can opt out, you can visit the Network Advertising Initiative’s opt-out page, the Digital Advertising Alliance’s opt-out page, or http://youronlinechoices.eu.
To opt out of Google Analytics for display advertising or customize Google display network ads, you can visit the Google Ads Settings page. To the extent advertising technology is integrated into the Pharmaoffer Platform and you opt-out of tailored advertising, you may still receive advertising content. In that case, the advertising content will just not be tailored to your interests. Also, we do not control any of these opt-out links and are not responsible for the availability or accuracy of these mechanisms.

Third Party Social Plugins

The Pharmaoffer Platform may use social plugins provided and operated by third parties, such as Facebook’s Like Button. As a result of this, you may send to the third party the information that you are viewing on a certain part of the Pharmaoffer Platform. If you are not logged into your account with the third party, then the third party may not know your identity. If you are logged in to your account with the third party, then the third party may be able to link information or actions about your interactions with the Pharmaoffer Platform to your account with them. Please refer to the third party’s privacy policies to learn more about its data practices.

Your Choices

Most browsers automatically accept cookies, but you can modify your browser setting to decline cookies by visiting the Help portion of your browser’s toolbar.
Your mobile device may allow you to control cookies through its settings function. Refer to your device manufacturer’s instructions for more information.
If you choose to decline cookies, some parts of the Pharmaoffer Platform may not work as intended or may not work at all.

 

 

 

 

 

Hvad er det FDA?
Food and Drug Administration

David Blok | Udgivet den 23. oktober 2023

  1. Introduktion
  2. Rollen af FDA i lægemiddelindustrien
  3. FDA Godkendelsesproces
  4. Nøglevilkår forbundet med FDA
  5. Virkningen af FDA Beslutninger om lægemiddelindustrien
  6. FDA's globale indflydelse
  7. Kritik og kontroverser
  8. Konklusion

Introduktion

Har du nogensinde spekuleret på, hvem der sikrer, at den medicin, du tager, er sikker og effektiv? Gå ind i FDA. Tjener som vogter af folkesundheden FDA spiller en central rolle i den farmaceutiske industri. Men hvad er det helt præcist FDA, og hvorfor betyder det noget for branchefolk?

Kort historie om FDA

FDA, eller US Food and Drug Administration, har sine rødder spor tilbage til det tidlige 20. århundrede. Etableret i 1906 var dens primære mission at beskytte forbrugerne mod forkerte og forfalskede fødevarer, lægemidler og kosmetik. I løbet af årtierne blev dens ansvar udvidet, hvilket gjorde den til den kraftcenterregulator, den er i dag.

Rollen af FDA i lægemiddelindustrien

Forestil dig det farmaceutiske landskab uden en vagthund. Risikabelt, ikke? Det FDA træder ind for at udfylde denne afgørende rolle.

Sikring af lægemiddelsikkerhed

Sikkerheden er i højsædet. Inden et stof kommer på markedet, gennemgår det en streng undersøgelse af stoffet FDA. Dette sikrer, at fordelene ved lægemidlet opvejer eventuelle potentielle risici.

Overvågning af kliniske forsøg

Kliniske forsøg er rygraden i lægemiddeludvikling. Det FDA overvåger disse forsøg og sikrer, at de udføres etisk, og at de genererede data er nøjagtige og upartiske.

Regulering af håndkøbs- og receptpligtig medicin

Ikke alle stoffer er skabt lige. Mens nogle fås i håndkøb, kræver andre en læges recept. Det FDA klassificerer og regulerer disse lægemidler og sikrer, at håndkøbslægemidler er sikre til offentligt forbrug uden kyndig tilsyn, mens receptpligtig medicin administreres under en sundhedspersons vejledning.

Vejen til FDA Godkendelse

Store skridt i FDA's lægemiddelgennemgang

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dyreforsøg

Sponsor tester medicin på flere dyrearter for at indsamle information om sikkerhed og effekt.
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IND ansøgning

Sponsor indsender en Investigational New Drug (IND) ansøgning, som omfatter indledende fund og planer for forsøg med mennesker, for FDA anmeldelse.
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Kliniske forsøg

Sponsor påtager sig tre faser af kliniske forsøg, der gradvist øger antallet af frivillige, for at bestemme lægemidlets bivirkninger, sikkerhed og effektivitet.
ekstern-eksamen-online-læring-foto3ideastudio-gradient-photo3ideastudio-1
NDA ansøgning

Sponsor indsender en ny lægemiddelansøgning (NDA), som omfatter resultater fra kliniske forsøg, for FDA anmeldelse.
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Etiketgennemgang

FDA sikrer, at passende information til både sundhedspersonale og forbrugere er inkluderet på lægemiddeletiketten.
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Godkendelse

FDA enten godkender eller afviser lægemidlet til det amerikanske marked.
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Overvågning efter markedsføring

Sponsor indsender periodiske sikkerhedsopdateringer til FDA.

by Ikoner8

Kilde: US Food and Drug Administration.

    FDA Godkendelsesproces

    Et lægemiddels rejse fra laboratoriet til apotekshylden er indviklet. Lad os afmystificere FDA's godkendelsesproces.

    Faser af kliniske forsøg

    Et lægemiddel gennemgår flere faser af kliniske forsøg, før det anses for sikkert:

    1. Fase I: Sikkerhedsevaluering med et lille antal deltagere.
    2. Fase II: Effekt- og bivirkningsvurdering i en større gruppe.
    3. Fase III: Storstilet test for at bekræfte effektivitet og overvåge bivirkninger.
    4. Fase IV: Overvågning efter markedsføring.

    For at få en dybere forståelse af forviklingerne ved kliniske forsøg, især i relation til Active Pharmaceutical Ingredients (API), bør du overveje at læse 'ALT DU BEHØVER AT VIDE OM API KLINISKE FORSØG'.

    Overvågning efter godkendelse

    FDA's job ender ikke med lægemiddelgodkendelse. Det overvåger løbende lægemidler for eventuelle negative virkninger, hvilket sikrer langsigtet sikkerhed.

    Nøglevilkår forbundet med FDA

    Lad os afkode nogle jargon forbundet med FDA.

    Ny lægemiddelansøgning (NDA)

    En NDA er det formelle skridt, en lægemiddelsponsor tager for at anmode om, at FDA overveje et lægemiddel til kommerciel markedsføring og salg.

    Generisk lægemiddel

    Et generisk lægemiddel er et lægemiddel, der tilbyder de samme terapeutiske fordele som dets varemærkemodstykke, men sælges under et andet navn.

    Biologics License Application (BLA)

    For biologiske produkter som vacciner indsendes en BLA i stedet for en NDA. Det er FDA's grønt lys for produktion og salg.

    Virkningen af FDA Beslutninger om lægemiddelindustrien

    FDA har stor indflydelse i den farmaceutiske verden. Dets beslutninger kan tage eller ødelægge et lægemiddels fremtid. Fra tidsplaner for godkendelse, der påvirker en virksomheds aktiekurs, til tilbagekaldelser, der kan skade et brands omdømme, FDA's domme overvåges nøje af industriens interessenter.

    For at dykke dybere ned i de udfordringer, medicinalvirksomheder kan stå over for på grund af FDA beslutninger, overvej at læse 'Navigerer i FDA's advarselsbrev: En omfattende vejledning'. 

    FDA's globale indflydelse

    Mens FDA er en amerikansk enhed, mærkes dens indflydelse globalt. Mange lande ser på FDA's beslutninger som benchmark. Når FDA godkender et lægemiddel, baner det ofte vejen for godkendelser i andre nationer.

    Kritik og kontroverser

    Ingen institution er uden sine kritikere. Det FDA, givet sin centrale rolle, har stået over for sin andel af kontroverser. Fra beskyldninger om at være for langsom med at godkende livreddende lægemidler til bekymringer om potentielle interessekonflikter, er det vigtigt at forstå de udfordringer FDA navigerer.

    Konklusion

    FDA, en vogter af folkesundheden, spiller en uundværlig rolle i den farmaceutiske industri. Dens beslutninger, baseret på streng videnskabelig evaluering, har til formål at sikre, at de lægemidler, vi indtager, er sikre og effektive. Som fagfolk i den farmaceutiske industri, at forstå FDA's funktioner og processer giver os bedre mulighed for at navigere i det komplekse landskab af lægemiddeludvikling og markedsføring.

    Hvad er forskellen mellem FDA og EMA?

    6
    7

    FDA er det regulerende organ for USA, mens EMA (European Medicines Agency) fører tilsyn med lægemiddelgodkendelser i EU.

    Hvor lang tid tager det FDA godkendelsesprocessen typisk tage?

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    7

    Mens tidslinjerne varierer, tager det ofte omkring 8-12 år fra lægemiddel opdagelse til FDA godkendelse.

    Er FDA-godkendte lægemidler altid sikre?

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    FDA sikrer, at lægemidler har fordele, der opvejer risici. Men som alle medicinske indgreb er intet lægemiddel helt uden risiko.

    Kan et stof miste sin FDA godkendelse?

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    7

    Ja. Hvis der opstår nye sikkerhedsproblemer, eller hvis lægemidlets fordele ikke længere opvejer dets risici, FDA kan tilbagekalde sin godkendelse.