Call for Volunteers to participate on a Veterinary Electronic Submissions Working Group

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Dear Stakeholder:

In the 2002 Speech from the Throne, the Government of Canada made a commitment to speed up the regulatory process for drug approvals to ensure that Canadians have faster access to the safe drugs they need and to create a better climate for research on drugs. In response, Health Canada initiated the Therapeutics Access Strategy (TAS) with partners and stakeholders. A component of TAS is the electronic review initiative (E-review) which is intended to develop technologies that support better processing of submissions from industry, create faster and more accurate automated workflows, foster information sharing in the system, and provide better access to information to both stakeholders and the public. E-review is on target to be fully functional by March 2008.

To take full advantageof the specifications published in the Guidance for Industry - Preparation of Veterinary New Drug Submissions and to design practical and efficient solutions to the transmission, receipt and processing of electronic information, it is necessary to work in partnership with key stakeholders. Stakeholder involvement in E-review first began in 1999, and continues today in the E-Review initiative through the HPFB Advisory Committee on Electronic Submissions (ACES).

To assist in providing timely and on-going advice on technical issues associated with electronic interchange, ACES has recommended the formation of a Working Group on Veterinary Electronic Submission (WGVES). WGVES will develop and recommend actions on a wide range of issues related to E-Submissions¹, including but not limited to the following:

• Assisting Health Canada in the development of E-submissions;
• Providing input to guidance to industry documentation;
• Developing specifications for veterinary drug E-submissions;
• Determining industry readiness for migration to E-submissions.

By way of this notice, Health Canada is soliciting nominations from key Canadian partners, associations and stakeholders to fill five positions on the Working Group. Nominees should possess experience in information management (such as knowledge of the International Conference on Harmonization (ICH) M2 standards, specifications as provided in the Guidance for Industry - Preparation of Veterinary New Drug Submissions and XML) and a good understanding of the regulatory process. Nominees are asked to submit a letter expressing their interest, summarizing their expertise and a curriculum vitae to
E-review@hc-sc.gc.ca by November 10, 2005.

Working Group members will be selected from the list of nominees by ACES so as to achieve the best combination of expertise and broad representation of key stakeholder interests. We anticipate holding three to four meetings a year commencing early in 2006.

Yours sincerely,

Kathy Dobbin,
Acting Director General
Veterinary Drugs Directorate