Below are some basic questions about the Pharmaceutcical Industry and how Templar 5 address the issues.

What is pharmacovigilance?
Pharmacovigilance encompasses surveillance of side effects after short-term and long-term use of medicines. Also referred to as Adverse Events.

What is the ESTRI Gateway?
The Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway allows the electronic filing of regulatory information. The purpose of the ESTRI Gateway is to place a centralized, Agency-wide gateway into day-to-day operations for receiving regulatory submissions securely within the U.S. Food and Drug Administration.

What is EudraVigilance?
EudraVigilance is the European data-processing network and database management system for the exchange, processing and evaluation of Individual Case Safety Reports (ICSRs) related to medicinal products authorized in the European Economic Area (EEA).

The purpose of the EudraVigilance Gateway is to operate a single, common, EEA-wide Gateway for receiving regulatory submissions in a fully automated and secure way including all aspects of privacy, authentication, integrity and non-repudiation of all transactions in pharmacovigilance.

The EudraVigilance Gateway allows the pharmaceutical industry to report to a common reporting point within the EEA from where the transactions are re-routed to the addressed Competent Authorities and the European Agency for the Evaluation of Medicinal Products (EMEA). It provides the Competent Authorities with a secure reporting mechanism to the pharmaceutical industry and to the EMEA. The pharmaceutical industry (i.e. marketing authorization holders) is responsible for implementing at least one of the multiple ESTRI standards in order to ensure electronic communication with any Regulatory Authority

Which Gateway solution is the FDA using?
The FDA is currently using Templar. The FDA does not require using Templar software, but does require interoperability with FDA's Templar system utilizing any comparable software with the same functionality.

Which Gateway solution is the EMEA using?
The EMEA is currently using Cyclone Commerce for their Electronic Gateway. The EMEA is not endorsing any particular software, but is must be compatible with EMEA's chosen solution. Templar version 5.3 is fully compatible with EMEA's solution.

Why use a Gateway?
•  Utilize the Internet for streamlined reporting of regulatory information.
•  Extremely Secure.
•  Reduces human error during data entry and handling of paper reports.
•  Creates a seamless electronic two way exchange for data.
•  Operates under open standards in accordance with the International Conference on Harmonization.

What does a Gateway do?
•  Tracks the full life cycle of industry data, logs receipts and sends acknowledgements. If a transaction fails, the gateway will automatically reprocess while simultaneously alerting the administrator. This entire process is fully automated.
•  Stores trading partner information within a trading partner agreement.
•  Stores public keys that authenticate individual trading partners.
•  Automatically receives and sends data, authenticate sender, encrypts/decrypts and processes to appropriate directory.

What are the benefits to using an Electronic Gateway?
•  Reduced Costs – avoiding the processing of paper and error in data entry for both Pharmaceutical companies and Regulatory Authorities.
•  Faster – individual case data is immediately available for rapid evaluation of potential safety issues.
•  Increased Consistency – the ability to have a standard format of data and transmissions to multiple regulatory authorities.
• Streamlined Processes – the ability to easily manage the entire life cycle of pharmacovigilence information, from managing duplicates, receipt acknowledgement and the identification of errors.