Pharmacovigilance Abbreviations / Acronyms

Term	Description
ADCO	Addendum to Clinical Overview
ADRs	Adverse Drug Reactions
AE	Adverse Event
AERS	Adverse Event Reporting System
ANDA	Abbreviated New Drug Application
ATC	Anatomical Therapeutic Chemical  (in Anatomical Therapeutic  Chemical Classification System)
ATMP	Advanced Therapy Medicinal Product
CAPA	Corrective And Preventive Action
CCDS	Company Core Data Sheet
CCSI	Company Core Safety Information
CHMP	Committee for Medicinal Products for Human Use
CIOMS	Council for International Organizations of Medical Sciences
CMDh	Coordination Group for Mutual Recognition and Decentralised  Procedures - Human
CMS	Concerned Member State
CRO	Contract Research Organization
CT	Clinical Trial
CTD	Common Technical Document
DCP	Decentralised Procedure
DDD	Defined Daily Dose
DHPC	Direct healthcare professional communication
DIBD	Development international birth date
DLP	Data Lock Point
DME	Designated Medical Event
DSUR	Development safety update report
DUS	Drug Utilization Study
EMA	European Medicine Agency
EU	European Union
EURD	European Union Reference Date
EV	Eudravigilance
FDA	Food and Drug Administration
GCP	Good Clinical Practice
GMP	Good Manufacturing Practice
GVP	Good Pharmacovigilance Practice
IB	Investigator´s Brochure
IBD	International birth date
ICH	International Council for Harmonisation of Technical Requirements for  Pharmaceuticals for Human Use
ICSRs	Individual Case Safety Reports
IME	Important Medical Event
IND	Investigational New Drug
INN	International Non-proprietary Name
LBI	Late Breaking Information
MA	Marketing Authorisation
MAH	Marketing Authorisation Holder
MedDRA	Medical Dictionary for Regulatory Activities
MHRA	Medicines and Healthcare Products Regulatory Agency
MRP	Mutual Recognition Procedure
NAP	National Authorised Product
NCA	National Competent Authority
NDA	New Drug Application
PASS	Post-authorisation safety study
PBRER	Periodic Benefit-Risk Evaluation Report
PI	Product Information
PIL	Product Information Leaflet
PL	Package Leaflet
PRAC	Pharmacovigilance Risk Assessment Committee
PSMF	Pharmacovigilance system master file
PSUR	Periodic Safety Update Report
PSUSA	Periodic Safety Update Single Assessment
PT	Preferred Term
PTD	Patient Treatment Days
PTY	Patient Treatment Years
PV	Pharmacovigilance
QPPV	Qulified Person responsible for Pharmacovigilance
REMS	Risk Evaluation & Mitigation Strategies
RMM	Risk Minimisation Measure
RMP	Risk Management Plan
RMS	Reference Member State
RSI	Referenced Safety Information
SAE	Serious Adverse Event
SAR	Serious Adverse Reaction
SDEA	Safety Data Exchange Agreement
SmPC	Summary of Product Characteristics
SMQ	Standardized MedDRA Query
SOC	System Organ Class
SOP	Standard Operating Procedure
TSSS	Tabular Summary of Safety Signals
WHO	World Health Organization
XEVIMPD	Extended EudraVigilance Investigational Medicinal Product Dictionary
XEVPRM	eXtended EudraVvigilance Product Report Message

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Privacy Policy

Effective date: December 04, 2018

DRUG SAFETY & PHARMACOVIGILANCE (PV) ("us", "we", or "our") operates the https://pvbasics.blogspot.com blog (hereinafter referred to as the "Service"). This page informs you of our policies regarding the collection, use, and disclosure of personal data when you use our Service and the choices you have associated with that data. Our Privacy Policy for DRUG SAFETY & PHARMACOVIGILANCE (PV) is managed with the help of Privacy Policies.

We use your data to provide and improve the Service. By using the Service, you agree to the collection and use of information in accordance with this policy. Unless otherwise defined in this Privacy Policy, the terms used in this Privacy Policy have the same meanings as in our Terms and Conditions, accessible from https://pvbasics.blogspot.com

Information Collection And Use

We collect several different types of information for various purposes to provide and improve our Service to you.

Types of Data Collected

Personal Data

While using our Service, we may ask you to provide us with certain personally identifiable information that can be used to contact or identify you ("Personal Data"). Personally identifiable information may include, but is not limited to:

• Email address
• First name and last name
• Cookies and Usage Data

Usage Data

We may also collect information on how the Service is accessed and used ("Usage Data"). This Usage Data may include information such as your computer's Internet Protocol address (e.g. IP address), browser type, browser version, the pages of our Service that you visit, the time and date of your visit, the time spent on those pages, unique device identifiers and other diagnostic data.

Tracking & Cookies Data

We use cookies and similar tracking technologies to track the activity on our Service and hold certain information.
Cookies are files with small amount of data which may include an anonymous unique identifier. Cookies are sent to your browser from a website and stored on your device. Tracking technologies also used are beacons, tags, and scripts to collect and track information and to improve and analyze our Service.
You can instruct your browser to refuse all cookies or to indicate when a cookie is being sent. However, if you do not accept cookies, you may not be able to use some portions of our Service. You can learn more about how to manage cookies in the Browser Cookies Guide.
Examples of Cookies we use:

• Session Cookies. We use Session Cookies to operate our Service.
• Preference Cookies. We use Preference Cookies to remember your preferences and various settings.
• Security Cookies. We use Security Cookies for security purposes.

Use of Data

DRUG SAFETY & PHARMACOVIGILANCE (PV) uses the collected data for various purposes:

• To provide and maintain the Service
• To notify you about changes to our Service
• To allow you to participate in interactive features of our Service when you choose to do so
• To provide customer care and support
• To provide analysis or valuable information so that we can improve the Service
• To monitor the usage of the Service
• To detect, prevent and address technical issues

Transfer Of Data

Your information, including Personal Data, may be transferred to — and maintained on — computers located outside of your state, province, country or other governmental jurisdiction where the data protection laws may differ than those from your jurisdiction.

If you are located outside India and choose to provide information to us, please note that we transfer the data, including Personal Data, to India and process it there.

Your consent to this Privacy Policy followed by your submission of such information represents your agreement to that transfer.

DRUG SAFETY & PHARMACOVIGILANCE (PV) will take all steps reasonably necessary to ensure that your data is treated securely and in accordance with this Privacy Policy and no transfer of your Personal Data will take place to an organization or a country unless there are adequate controls in place including the security of your data and other personal information.

Disclosure Of Data

Legal Requirements

DRUG SAFETY & PHARMACOVIGILANCE (PV) may disclose your Personal Data in the good faith belief that such action is necessary to:

• To comply with a legal obligation
• To protect and defend the rights or property of DRUG SAFETY & PHARMACOVIGILANCE (PV)
• To prevent or investigate possible wrongdoing in connection with the Service
• To protect the personal safety of users of the Service or the public
• To protect against legal liability

Security Of Data

The security of your data is important to us, but remember that no method of transmission over the Internet, or method of electronic storage is 100% secure. While we strive to use commercially acceptable means to protect your Personal Data, we cannot guarantee its absolute security.

Service Providers

We may employ third party companies and individuals to facilitate our Service ("Service Providers"), to provide the Service on our behalf, to perform Service-related services or to assist us in analyzing how our Service is used.
These third parties have access to your Personal Data only to perform these tasks on our behalf and are obligated not to disclose or use it for any other purpose.

Analytics

We may use third-party Service Providers to monitor and analyze the use of our Service.

• Google Analytics
  Google Analytics is a web analytics service offered by Google that tracks and reports website traffic. Google uses the data collected to track and monitor the use of our Service. This data is shared with other Google services. Google may use the collected data to contextualize and personalize the ads of its own advertising network.
  You can opt-out of having made your activity on the Service available to Google Analytics by installing the Google Analytics opt-out browser add-on. The add-on prevents the Google Analytics JavaScript (ga.js, analytics.js, and dc.js) from sharing information with Google Analytics about visits activity.
  For more information on the privacy practices of Google, please visit the Google Privacy & Terms web page: https://policies.google.com/privacy?hl=en

Links To Other Sites

Our Service may contain links to other sites that are not operated by us. If you click on a third party link, you will be directed to that third party's site. We strongly advise you to review the Privacy Policy of every site you visit.

We have no control over and assume no responsibility for the content, privacy policies or practices of any third party sites or services.

Children's Privacy

Our Service does not address anyone under the age of 18 ("Children").

We do not knowingly collect personally identifiable information from anyone under the age of 18. If you are a parent or guardian and you are aware that your Children has provided us with Personal Data, please contact us. If we become aware that we have collected Personal Data from children without verification of parental consent, we take steps to remove that information from our servers.

Changes To This Privacy Policy

We may update our Privacy Policy from time to time. We will notify you of any changes by posting the new Privacy Policy on this page.

We will let you know via email and/or a prominent notice on our Service, prior to the change becoming effective and update the "effective date" at the top of this Privacy Policy.

You are advised to review this Privacy Policy periodically for any changes. Changes to this Privacy Policy are effective when they are posted on this page.

Contact Us

If you have any questions about this Privacy Policy, please contact us:

• By email: neerajrathod6@gmail.com

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Disclaimer

This is a personal blog. The information contained in this blog is for general information purpose only.

All views express on this site are my own and do not represent the opinions of any entity whatsoever with which I have been, am now or will be affiliated. I am not responsible for any errors or omissions, or for the results obtained from the use of this information. All information in this blog is provided “as is”, with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information. Comments on this site are sole responsibility of their authors, but I reserve the right to delete any comment falling unacceptable criteria. The authors and the blog are not to be held responsible for misuse, reuse, recycled and cited and/or uncited copies of content within this blog by others.         

The blog may contains links to other websites such as drug regulatory agencies worldwide or content belonging to or originated from third parties or links to websites and features in banners or other advertising. Such external links are not investigated, monitored or checked for accuracy, adequacy, validity, reliability, legality or completeness by me. The information should not be use as a basis for the making business, legal or any other decisions.   

      

Any content provided here are not intended to malign any religion, ethnic group, club, organization, company, individual, anyone, or anything.

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