The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.
FDA released guidance in May 2019 to help sponsors demonstrate that a proposed therapeutic protein product is interchangeable with a reference product when submitting a marketing application or supplement under 351(k) of the Public Health Services Act. The guidance provides an overview of scientific considerations and discusses the type and amount of data needed to support interchangeability.
Specifically, the guidance addresses product-dependent factors such as product complexity and immunogenicity risk. Biosimilar postmarketing data are also discussed. FDA also details considerations for switching studies to support demonstration of interchangeability including study endpoints, study design and analysis, study population, conditions of use, and route of administration. Also discussed in the guidance are the development of presentations for proposed interchangeable products and postmarketing safety monitoring.
Information source: http://www.pharmtech.com/fda-publishes-guidance-interchangeability-protein-products-0
These terms of use are binding for Makromedicine.com, its distribution partners, and all related portals (see paragraph 2).
1. Preface
By using Makromedicine.com (including searching the database, visiting profiles, adding/updating information as well as submitting any information to the portal) or a related portal (see below "Party to the Contract") you agree to these Terms of Use.
2. Party to the Contract
The Makromedicine.com Database is property of and managed by Makromed LLC, Baku, Azerbaijan. Database subscription agreements are made between the subscriber and Makromed LLC. These Terms of Use are also binding for all portals related to Makromedicine.com and for all Makromedicine.com 's distribution partners (such as any portal mentioned at https://mm.lunacenter.us). Therefore in the following Terms of Use, the expression "Makromedicine" includes the Makromedicine.com Database as well as all related portals.
3. Publishing of company profiles
Adding and updating company profiles to Makromedicine.com is completely free of charge. Makromed LLC reserves the right to exclude or otherwise edit any information submitted to its databases. All profiles will be reviewed prior to activation.
4. Extent of Available Information
The number of profiles and additional information available on our website may vary from day to day. We do our best to increase the extent of the available information and its accuracy. Each profile can be updated by the organization itself. Makromed LLC then checks the updated data before it is put online. However, we do not guarantee a minimum number of available company profiles, nor the completeness or accuracy of any profile published in the database. Makromed LLC cannot be held liable for any information available or missing from the database.
5. Quality of available information
Makromed LLC assumes no liability for any damage or loss arising from access to or use of the Makromedicine.com website, the database, and the information contained therein.
The Makromedicine.com Database and all the data included in the database are free of any infringements of any third party’s rights and/or breaches of Makromedicine.com obligation under other agreements.
6. Use of information
The subscriber agrees that any downloaded content will be used for internal purposes only. Particularly, data harvesting will not be allowed, nor the unreasonable use of contact details in sending out emails. Furthermore, no data can be made available to third parties. No part of this website may be reproduced or transmitted in any form or by any means, electronically, mechanically, by photocopying, by recording, or otherwise, without prior permission from Makromed LLC. All data must be deleted if your subscription to this data ends.
7. Extent of use
Makromedicine.com subscriptions are not restricted in terms of the amount of data, but are intended for reasonable usage. The "unlimited" access a subscriber gets to the database does not constitute the right to systematically download all available information in the database. Makromed LLC has the right to block or cancel an account if Makromed LLC deems that a subscriber has exceeded the limit of normal usage (especially if it can be inferred that a subscriber is collecting e-mail addresses). Any use of automated data collecting software is strictly prohibited.
8. Subscriptions & Pricing
Unless otherwise stated in the proposal, the prices for subscriptions are valid for one (1) license per person for the corresponding time period (see also "Automatic Renewal" below). All terms described in this document also apply to site licenses (multiple users). Special rates are available for small and mid-size companies. Please contact us for more details (see below "Contact information").
We keep the right to vary or increase the prices of the subscriptions. Price increases for auto-recurring payments will be announced by e-mail at least one month prior to the renewal of the subscription. If a subscriber does not agree to the new pricing, the subscription can be canceled according to the terms described under "Cancellation of Subscription".
9. Automatic Renewal
Unless you cancel your database subscription, subscriptions will be automatically renewed for the duration that you signed up for and the payment method on record will be automatically charged accordingly. The automatic renewal will be processed 1 to 2 days before the subscription for the current period expires. The receipt for this recurring payment can be downloaded from the "My account - Subscriptions" area in your profile on Makromedicine.com and with the link in the confirmation mail that is being sent to you. Please make sure you have a current e-mail address registered in your profile.
10. Cancellation of Subscription
A subscription can be canceled up to two days before the current subscription period ends. You can cancel your subscription either in the area "My account - Subscriptions" or by sending us an e-mail (see "Contact information" below). If you canceled later, the subscription fee for one more period will be charged to your credit card.
If you cancel a recurring subscription, the subscription remains active until the end of the period for which the last payment has been made.
If you cancel a subscription by e-mail, you will receive an e-mail notification once the subscription has been canceled. If you do not receive such a notification within 48 hours after cancellation, it must be assumed that we did not receive the e-mail. In this case please contact us again.
11. Refund of payments
Makromed LLC does not refund any payments after the cancellation of the subscription. If a subscription is canceled, no further payments will be charged in the future.
12. Expired Subscriptions
If a subscription expires, the account is still available to the user for at least one year after the date of expiration but the extent of information and features will be limited.
13. Use of subscriber's company for reference purposes
Unless otherwise stated in the proposal, Makromed LLC has the right to use the company name and logo of users as a reference on its websites, in email marketing campaigns, on printed materials, or on social media. If a client does not agree to this, the client must inform Makromed LLC in writing. Makromed LLC will then remove the logo and company name from all its website(s) within 14 days and will not use them in any future campaigns and printed material.
14. Limitation of Liability
In no event shall Makromed LLC be liable for damages resulting from loss of data or use of the Makromedicine.com Database, or for any incidental, indirect, punitive, or consequential damages in connection with this agreement or in connection with any products or services provided. We shall exert our best effort to provide you with the highest availability of Database services. We are, however, dependent on external parties and cannot provide any guarantee as to availability or accuracy. We reserve the right to change external parties and information providers at any time.
15. Copyright
All content on Makromedicine.com and its related portals, including text, graphics, logos, button icons, images, audio clips, video clips, digital downloads, data compilations, and software, is the property of Makromed LLC or its content suppliers and protected by international copyright laws. The compilation of all content on this site is the exclusive property of Makromed LLC and protected by international copyright laws. All software used on this site is the property of Makromed LLC or its software suppliers and is protected by international copyright laws.
16. License and Site Access
Makromed LLC grants you a limited license to access and make personal use of this site but not to download (other than page caching) or modify it, or any portion of it, except with expressed written consent of Makromed LLC. This site or any portion of this site may not be reproduced, duplicated, copied, sold, resold, visited, or otherwise exploited for any commercial purpose without expressed written consent from Makromed LLC. This license does not include any resale or commercial use of this site or its contents or any derivative use of this site or its contents.
17. Applicable Law
By visiting Makromedicine.com or a related portal, you agree that the laws of Switzerland, without regard to principles of conflict of laws, will govern these Conditions of Use and any dispute of any sort that might arise between you and Makromed LLC or its affiliates.
18. Site Policies, Modification, and Severability
We reserve the right to make changes to our site, policies, and these Terms of Use at any time. If any of these conditions shall be deemed invalid, void, or for any reason unenforceable, that condition shall be deemed severable and shall not affect the validity and enforceability of any remaining conditions.
19. Changes to Terms of Use
If Makromed LLC decides or needs to change these Terms of Use, it will post those changes in this Terms of Use and other places deemed appropriate. Makromed LLC reserves the right to revise, amend, or modify these Terms of Use, and any of our other policies and agreements at any time and in any manner, so please review this document frequently. If we make any changes to these terms, we will notify you here or by means of a notice on our homepage.
20. Contact information
Makromed LLC
sizin unvaniniz
Azerbaijan
Phone:
Fax:
E-mail:
www.makromedicine.com
21. Update history
These Terms of Use were published on May 04, 2022.
1. Introduction
Makromed LLC, through its database Makromedicine.com, will collect and process your personal data and any other information relating to your interactions and dealings with us or through external sources like press releases, company websites, and other publicly available databases. This Privacy Policy explains how we will manage your personal data, the purposes for which we use it, the security measures we have put in place to protect your data and what your rights under data protection legislation are, and how you may choose to exercise these.
Personal Data is defined as information relating to identifiable living individuals, which we have obtained or you provide to us, such as your name, address, email address, telephone number, date of birth, ID Card, from which you can be directly or indirectly identified, and may include but not limited to information such as employee number, IP addresses, and online identifiers.
2. Data Controller
Makromed LLC is defined as the Data Controller of personal data collected via Makromedicine.com and is therefore responsible for protecting your personal data in line with our obligations under data protection legislation.
We may use third parties to process your personal data (Data Processors) where we have outsourced a particular function or where we wish to avail of that third party’s expertise in providing the particular service. These third parties will be carefully selected to ensure that your data is adequately protected by the use of appropriate technical and organizational security measures.
3. Sources of Personal Data
Customers/ Prospective Customers
We obtain personal data where you provide this directly to us where you enter your information into an online form to contact us regarding our services and where you fill in the company, management, and personal profile in Makromedicine.com.
Public sources
We obtain company and personal data from external, publicly available sources such as the internet, press releases, conferences, and other sources we deem reliable to complete and complement our dataset of a company profile.
4. Purposes of Data Collection
We use personal data in our capacity as a commercial enterprise in furtherance of our business activities and as an employer. The purposes for which we use personal data can be summarised as follows:
For collecting information for a global business development database designed for the pharmaceutical industry, containing key information about companies involved in its respective sectors such as biotechnology, pharmaceuticals, and medical technology.
For the purposes of advertising, direct marketing, and public relations i.e. where you provide your email address to receive our newsletter;
To perform functions of a commercial enterprise i.e. to perform accounting and other record-keeping functions;
5. Legal Basis for using Personal Data
We rely on the following legal bases under data protection legislation to process your personal data:
I. Consent
Where you provide your email address for the purpose of signing up to receive our newsletter, we rely on Article 6(1)(a) of the GDPR in processing your data for this purpose. You may revoke this consent at any time by unsubscribing from our email list by clicking the unsubscribe link at the end of every email and by emailing us using the contact details provided below.
II. Performance of a Contract
Where you provide your email address for the purpose of signing up to receive our newsletter, we rely on Article 6(1)(a) of the GDPR in processing your data for this purpose. You may revoke this consent at any time by unsubscribing from our email list by clicking the unsubscribe link at the end of every email and by emailing us using the contact details provided below.
III. Legitimate interests
Where we rely on legitimate interests or the legitimate interests of a third party to process your personal data we will require data for legitimate purposes such as:
For day to day operational and business purposes
The pursuit of our activities as a commercial enterprise or that of a third party e.g. managing our contracts and relationships with our customers, suppliers, service providers, vendors, and other commercial partners
Compliance with legal and regulatory obligations
Development of any guidelines, improvement, and development of business operations and service offerings
Conducting analytical and statistical research and profiling
To help us improve our services and systems and to improve your experiences on our website
To provide you with information in relation to our products and services where we are permitted to do so
The reorganization or sale of the whole or part of our business
6. Disclosure of Personal Data
We will not disclose your personal data except as outlined above and/or as follows:
For day to day operational and business purposes of our global business development database, allowing registered, paying subscribers to contact individuals within a target company
Where the disclosure is necessary to enable us to carry out our obligations under any agreement we have with you
Where we need to provide your data to counterparties to transactions entered into by you e.g. payment service providers
Where we need to share your personal data with our auditors in accordance with applicable tax and regulatory reporting obligations
Where we need to share your personal data with our legal advisors where necessary to establish, exercise, or defend our legal rights or for the purposes of legal proceedings.
Where we are required to share information to any (or proposed) assignee, transferee, or successor in title to the whole or any relevant part of our business, and their respective officers, employees, agents, and advisers; and
If the disclosure is required by law or regulation, or court or administrative order having the force of law, or is required to be made to any of our regulators
7. Other Recipients of your Personal Data
In any case, where we share your personal data with a third-party data controller, your personal data will be used by that third party subject to their own privacy policies.
8. International Transfers of Personal Data
Personal data may be transferred outside of the European Economic Area (EEA) in line with the purposes set out above and this may include transfer to a country that is not currently deemed by the European Commission to have adequate data protection legislation in place.
In such cases, we will use data transfer mechanisms approved under the General Data Protection Regulation such as standard contractual clauses or data transfer agreements such as the EU-US Privacy Shield.
Any subscriber of Makromedicine.com have to comply with the General Data Protection Regulation.
9. Security of Personal Data
We use appropriate technical and organizational measures to protect your personal data.
Where data is stored electronically, we have implemented appropriate IT security measures to secure your personal data. These measures include and are not limited to anti-virus protection, firewalls, and data encryption technologies. Where data is stored in hard copy format, we have procedures in place and staff training to ensure that paper records are stored securely. Unfortunately, no data transmission over the Internet or electronic storage system can be guaranteed as secure, however, we will ensure that the technical and organizational measures in place are regularly reviewed to ensure that they are up-to-date and functioning effectively.
10. Retention of Personal Data
Personal data will be kept for as long as it is legally required to be kept or for as long as the business has a legitimate need to keep the data for the purposes for which it is originally collected.
Where we hold personal data to provide a product or a service to you we will hold the information for as long as it is required to fulfill the terms of that agreement with you and for a period of 10 years after the end of the customer relationship thereafter to ensure compliance with tax requirements.
Other information will be retained by us for no longer than is necessary for the purposes for which it was obtained or as required or permitted for legal, regulatory, fraud prevention, and legitimate business purposes.
For further information on the period of time for which we retain your personal data please contact us using the details below.
11. Personal Data Rights
The following is a summary of the rights available to you under data protection legislation. These rights may only apply in certain circumstances and may be subject to certain exemptions. Where you make an application for the exercise of your rights, this will be considered on a case by case basis.
I. Updating and correcting your personal data
If we hold incorrect personal data about you, you have the right to have this data amended. While we use reasonable efforts to keep your personal data up-to-date, you will need to notify us where you require your details to be updated in cases when we will be unaware of your change in circumstances.
II. Right of Erasure
You have the right in some circumstances to have your personal data erased i.e. where your personal data has been processed unlawfully or if you object to our processing of personal data on grounds relating to your particular situation and we have no overriding grounds to continue using it, or where you have previously provided consent to the data processing you now wish to withdraw that consent.
However, we will not be required to erase your data where to do so would prevent us from meeting our respective contractual obligations, or where we are required to process (including retaining) your personal data in order to comply with a legal obligation, or if the data is required to establish, exercise or defend our legal rights for the purposes of legal proceedings.
III. Right of Access
You have a right to be given a copy of your personal data on request, subject to certain exceptions which may apply. We have 30 days from the receipt of the request to provide you with a copy of this data. This period may be extended to a further period of 60 days in specific circumstances.
IV. Right to Restriction
You also have the right, in certain circumstances, to request restrictions on the use of your personal data, in each case subject to the restrictions set out in applicable data protection laws.
V. Right to Withdraw Consent
Where you have previously consented to the use of your personal data, you have the right to withdraw this consent and may notify us of your intention to do so.
Where we rely on a legitimate interest of ours, or a third party recipient of the personal data, in order to use or disclose personal data, you are entitled to object to such use or disclosure of your personal data and if you do so will cease to use and process your data for that purpose, unless we can demonstrate that there are compelling legitimate reasons for us to continue using the data or where we require the data for the purpose of legal claims.
VI. Right to Data Portability
In limited circumstances, you may also have the right to receive your data saved onto a portable medium i.e. a structured, commonly used, and machine-readable format, or transmit it to a third party where this is technically feasible.
VII. Right to Lodge a Complaint
You also have the right to lodge a complaint in respect of how your personal data has been processed by us with the Data Protection Commission in your home country or with the Federal Data Protection and Information Commissioner ('FDPIC') in Switzerland.
12. Applicable Law
By visiting Makromedicine.com you agree that the laws of Switzerland, without regard to principles of conflict of laws, will govern this Privacy Policy and the forum for a dispute of any sort that might arise between you and Makromed LLC or its affiliates will be determined by the courts of Switzerland.
13. Contact information
Makromed LLC
sizin unvaniniz
Azerbaijan
Phone:
Fax:
E-mail:
www.makromedicine.com
14. Update history
This Privacy Policy (v2) was published on May 04th, 2022.
Cookies are very small text files that store very small amounts of information. They are used to remember settings and preferences between visits to the site, as well as information between different pages on the same site.
For security reasons, cookies can only be read by the site that sets them. We have no access to cookies set on your computer by, for example, Google, Firefox, Edge, or any other website on the internet. However, through the use of third-party cookies, it is possible for sites to collect information about visitors to other sites. For example, online advertisers may use third-party cookies to anonymously track an individual's visits to sites on the web.
More information about how we allow third-party cookies on our sites is given below.
To find out more about cookies in general, you might find the following link useful: Wikipedia: HTTP Cookies
Currently, there are four types of cookies that may be generated as you browse our site: session cookies, preference cookies, analytics cookies, and third-party cookies.
1. Session Cookies
As you move through the site, various pieces of information need to be stored in order for the site to function properly. For example, if you perform a search for companies, the search criteria you use will be remembered so that you can change them later. If you log in to your Makromedicine.com account, we will remember your login settings and access rights.
This information is stored on our server. We set one cookie to keep track of which session you are using. Old session data is automatically deleted from our server multiple times a day or automatically if you log out of your account or close the browser. So we do not store this information long-term.
How do I control session cookies?
You can use your browser settings to control whether or not we set session cookies. More information on your browser settings is provided at the bottom of this page.
Please be aware that cookies are critical to the working of the site. If you choose to disable cookies from this site, the site functionality will be greatly reduced. In addition, you will not be able to log in to your Makromedicine.com account.
2. Preference Cookies
We use preference cookies to allow your browser to remember choices and preferences you did during your current or previous visits to our website. We use these cookies as follows:
When you click OK to signify that you have accepted cookies, we set a cookie. We will then not display the banner at the top of the page anymore.
If you log in to your Makromedicine.com account, you can tick a checkbox to remember your username and password in order to enable auto-login. This information is saved in a cookie.
You may see a pop-up window once in a while that asks you to subscribe to our newsletter. We set a cookie to save if you already subscribed for a newsletter or if you wish not to see this pop up anymore.
How do I control preference cookies?
These cookies are set as a direct result of your choice, and function solely as indicators of what that choice was. We do not believe they pose any risk to your privacy. However, you can always use your browser settings to control whether or not our site can set cookies on your computer. Also, you can delete these cookies in your browser settings anytime.
Please be aware that cookies are critical to the functionality of the site. If you choose to disable cookies from this site, the site functionality will be greatly reduced. In addition, you will not be able to log in to your Makromedicine.com account.
3. Analytics Cookies
In order to monitor how our sites are performing, we collect data about page visits. This information is completely anonymous – we cannot determine who it came from. When we use this data, we look at the number of visitors overall rather than individual visits.
Analytics information is used in reports and to improve our site. For example, we have used analytics data to add, remove or change features of the site based on how popular they are with users.
We track, for example:
the numbers of visitors to individual pages;
when pages were visited;
how long users stayed on the page;
the page they came from;
Technical data about the device being used to browse the site (such as browser and operating system version, and display size) – we use this data to ensure that the technology our site uses is appropriate for the majority of our users, and how best to display the site for users who have less capable browsers.
We use Google And StatCounter to provide our analytics data. You can read more about how Google Analytics treats your data at Google: Safeguarding your data.
More information about StatCounter is available on their website: Statcounter
How do I control analytics cookies?
Google provides a tool to opt out of Google Analytics. This is available for all modern browsers in the form of a browser plugin.
Additionally, you can control how cookies are set using your browser settings. See below for more information.
A browser is a program you use to view web pages. Your browser allows you to control what cookies are set on your computer, and how long they are stored. You may have more than one browser installed on your computer. In this case, you will need to change the settings for each browser you use.
Browser help pages relating to cookie settings
Browser manufacturers provide help pages relating to cookie management in their products. Please see below for more information.
For other browsers, please consult the documentation that your browser manufacturer provides.
If you still have any concerns relating to our use of cookies, please contact us at:
Makromedicine email address.
If this page is in your subscriptions, then it will be removed. You will not see this page. If you want to unblock a user, go to the settings, the list of blocked users and click unblock
After registration a request will be send administrator of the page for approval.
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