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                CVM Offices

CVM Offices

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          CVM Offices
          Strategic PlanCVM Offices Strategic Plan
  
  	
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*Enhancement of Global Outreach through
Leadership, Coordination, and Management*

Center for Veterinary Medicine
International Affairs

Strategic Plan

Mission

The mission of the Center for Veterinary Medicine (CVM) is to protect U.S. human and animal health by assuring the safety and efficacy of animal drugs, including drugs intended for food producing animals, and the safety of animal feeds and pet foods.

The role of International Affairs is to lead, coordinate, and manage CVM’s international activities in collaboration with relevant FDA Centers and Offices, including the Office of International Programs and Office of Regulatory Affairs, as well as FDA’s international regulatory counterparts, to advance the overall mission of CVM and FDA.

As part of its work, CVM-IA will seek the establishment of programs that promote and protect animals, and humans who are exposed to them, through use of One Health strategies that decrease the spread of zoonotic diseases and enhance the societal importance of the human-animal bond globally.

Strategic Partners

The CVM-IA will accomplish its mission by working with various strategic partners within and outside of FDA. The following are the primary partners CVM-IA will engage with:

FDA’s Office of International Programs
	Other FDA Centers and Offices
	USDA
	USAID
	CDC
	EPA
	WHO and PAHO
	WOAH
	CODEX
	VICH
	Other regulatory agency counterparts
	FAOSummary of Goals

Goal A – Regulatory and Technical Capacity Building
	Goal B – Innovative and Emerging Technology Initiatives
	Goal C – Global Pharmacovigilance and Post-Market Surveillance
	Goal D – Leverage Resources Across Internal and External StakeholdersGoals and Objectives

**Goal A – Regulatory and Technical Capacity Building** - Provide scientific and regulatory knowledge to CVM’s regulatory counterparts, international standard-setting organizations, and industry

Exchange scientific/regulatory information between CVM and its regulatory counterparts, international standard-setting organizations, and industry
	Periodically distribute the “Informational Needs Assessment Questionnaires” internationally for CVM to gain insight into the scientific and regulatory needs of its international counterparts and industry
		Develop and maintain working relationships with regulators, scientists, and industry personnel in foreign countries
		Use multilateral discussion groups/scientific forums for sharing current information
		Develop alternative approaches to resolving non-scientific issues for any products including products involving new technologies
		Reduce barriers that hinder collaboration among a global network of international counterparts and industry (for example, by using Confidentiality Agreements)
		Develop and maintain an FDA CVM-IA Internet web page devoted to CVM’s international activities
		Maintain list of frequently asked questions (FAQs) on the CVM-IA website for public information that relates to import safety and other topics of interest to an international audience
		Participate in the work of international organizations including those provided in Section D of this plan
		Use CVM’s membership on leadership/steering committees to help guide the direction of international organizations
			Use CVM’s support role as members of various international working groups to provide technical/regulatory assistance within these working groups
	Sponsor and maintain educational programs for international training on both regulatory and technical topics
	Use the CVM-IA internet web page as a training platform to include:
		Training portal for U.S. and International animal health workers
			Web-based training videos
		Sponsor and participate in international scientific and regulatory training workshops to improve regulatory science and increase the awareness worldwide of FDA requirements in a proactive effort to reduce the incidence of inspectional issues at the border
		Improve regulatory science by sponsoring, maintaining, and participating in educational programs for international training both on regulatory and technical topics
		Support translation of FDA educational and training documents into various languages**Goal B – Innovative and Emerging Technology Initiatives**- Lead coordination within CVM of international issues involving innovation

Be a source of information about innovative developments internationally and guide CVM’s work to avoid duplication of effort
	Maintain awareness of developments in other countries
	Ensure CVM’s presence at the table whenever innovative technologies in animal health are topics of international discussions
	Identify the appropriate countries and international organizations to approach about working jointly on specific innovations
		Establish communications between CVM experts and appropriate international partners
		Maintain liaisons with international partners concerning innovative technologies
	Reach out to identify new innovative technologies in other countries
	Match CVM experts with foreign counterparts to analyze important public and animal health questions about emerging, innovative technologies
	Work to eliminate international barriers that would prevent innovations from reaching the marketplace
	Identify potential international bottlenecks of high costs, high levels of corporate protectiveness; and provide guidance for avoiding problems
		Provide guidance on potential non-scientific hurdles in other countries**Goal C – Global Pharmacovigilance and Post-Market Surveillance**– The detection and investigation of adverse events from the use of animal drug products

The goal of this program is to identify safety signals and effectiveness issues of concern in order to protect animal and human health.

CVM can serve as an international collaborating center with additional funding, professional staff expansion, and IT support. Implementation of such a program would include:
	Utilizing questionnaires/surveys and other tools (PVS Gap Analysis) to assess country needs
		Developing memoranda of understanding
		Establishing legal/regulatory framework/guidance (VICH implementation)
		Using adverse event reports that are submitted electronically
		Using pharmacoepidemiology and data analysis reports
	CVM-IA will use the pharmacovigilance program to assist CVM to:
	Identify potential drug residue or contamination issues in food animals
		Serve as an early warning surveillance system to identify drug safety signals and effectiveness issues, and help identify emerging global issues
		Enhance the societal importance of the human-animal bond by protecting and promoting companion animal health
		Promote international collaboration, education, and training (outreach)**Goal D – Leverage Resources Across Internal and External Stakeholders**- CVM’s goals and mission should align with other FDA Centers and Federal agencies that have public health as a primary mission, including:

FDA Office of International Programs
	USDA (APHIS, FSIS, FAS)
	USAID
	CDC
	EPA
	Increase number, scope, and effectiveness of joint regulatory programs with foreign regulatory counterparts using various tools including:
	Inspections (PIC-S)
		Exchange of inspectional reports
		Parallel scientific advice for the review of veterinary drug applications
	Develop and sustain appropriate systems, processes, and procedures to assure alignment with the CVM International Affairs’ Strategic Plan
	Maintain alignment with the CVM’s strategic priorities (to be developed)
		Adopt Results Oriented Management (ROM) strategies to assess performance
		Utilize activity time reporting tied in with specific milestones (project management tool)
		Develop situational awareness and environmental competency of issues both domestic and global
		Commit to and value continual learning
	Coordinate the participation of CVM and ORA’s regulatory investigators in joint/collaborative exercises with international counterparts (e.g., cGMP collaboration – EMA)Next Steps

This Strategic Plan will guide CVM’s international activities as CVM-IA seeks to achieve its mission of the protection of human and animal health by approving safe and effective animal products given to food-producing and companion animals and monitoring the safe use of those products. The Plan outlines CVM’s strategic priorities for developing programs that assure the safety of imported veterinary drugs and feeds, the safety of human food, and the prevention and mitigation of animal disease worldwide.

CVM-IA will leverage its efforts to develop appropriate controls on animal drugs and feed by collaborating with international standard-setting and capacity building organizations and appropriate USG and foreign agencies to, for example, set standards for product reviews and develop conformity assessment procedures. CVM-IA will use tools such as Results Oriented Management techniques, training and educational activities developed by Decernis, and the results of the Best Practices Survey to help us accomplish its goals.

CVM-IA will work closely with its foreign regulatory counterparts, especially in countries that export products to the United States, and explain CVM’s requirements for assuring that only safe and effective animal drugs and feed are imported into the United States.

Finally, CVM-IA recognizes that the use of appropriate performance metrics and benchmarks will be an important component of this plan. CVM-IA will develop and use these tools to make timely assessments of the progress of the strategic plan's goals and objectives. CVM-IA will prepare annual progress reports to review with CVM’s CEB and with OIP in conjunction with CVM and OIP Strategic and Operational plans. Course changes will be made as new information or new opportunities develop.

                                                                                  Content current as of:
      11/07/2023CVM Offices

          
                        Office of the Director
          Office of Management
          Office of New Animal Drug Evaluation
          Office of Surveillance and Compliance
          Office of Applied Science
          Office of Minor Use and Minor Species
 
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