expected cpd outcome sfda capacity development project id ...€¦ · saudi food and drug authority...

United Nations Development ProgrammeCountry: Saudi Arabia

Project Document

Project Title: Support SFDA Second strategic plan implementation

SAU1O/82003Project ID:

Expected CPD Outcome #3: Sustainable Development Mainstreamed across the Economy

SFDA Capacity DevelopmentExpected Output(s):

Saudi Food and Drug AuthorityExecuting Entity:

Implementing Agencies: SFDA

Project SummarySFDA is the leading regional regulatory authority for food, drugs and medical devices with professionaland excellent services that contributes to the protection and advancement of the health in Saudi Arabia.In its continuing efforts to achieve its vision, SFDA recently developed its second strategic plan from2012 to 2016 which focuses mainly on building broad and deep capabilities, ensure thoroughness,transparency, and consistency in enforcement and communication, and complete the coverage of allrelevant areas. UNDP’s technical assistance in this project shall focus on the following outputs on thefollowing outputs; 1- Capacity development of SFDA; 2- Ensure thoroughness, transparency, andconsistency in enforcement and communication; 3- Complete the coverage of all relevant areas as perSFDA’s mandate; 4- Develop systems and processes to improve pro-activity in addressing emergingrisk

Programme Period: 2012—2016Total resources required US$ 17,759,492

Atlas Proposal ID: SAU1O!65588

Total allocated resources:Start date: 1sApnl 2012

0 Government $ US$ 17,759,492End Date 31st December2016

Previous unbudgeted SPAC Meeting Date 24th March 2012

Manaaement Arranoements NIM

Agreed by (SFDA):

Dr Mohammed AL Kanhal -

Executive President-

Agreed by ‘UNDP)/J / /

Kishan Khoday %./ //UNDP Resident Representative a

—_-- 7 /

United Nations Development ProgrammeCountry: Saudi Arabia

Project Document

Project Title: Support SFDA Second strategic plan implementation

SAU 10/82003Project ID:

Expected CPD Outcome #3: Sustainable Development Mainstreamed across the Economy

SFDA Capacity DevelopmentExpected Output(s):

Saudi Food and Drug AuthorityExecuting Entity:Implementing Agencies: SFDA

Project SummarySFDA is the leading regional regulatory authority for food, drugs and medical devices with professionaland excellent services that contributes to the protection and advancement of the health in Saudi Arabia.In its continuing efforts to achieve its vision, SFDA recently developed its second strategic plan from2012 to 2016 which focuses mainly on building broad and deep capabilities, ensure thoroughness,transparency, and consistency in enforcement and communication, and complete the coverage of allrelevant areas. UNDP’s technical assistance in this project shall focus on the following outputs on thefollowing outputs; 1- Capacity development of SFDA; 2- Ensure thoroughness, transparency, andconsistency in enforcement and communication; 3- Complete the coverage of all relevant areas as perSFDA’s mandate; 4- Develop systems and processes to improve pro-activity in addressing emergingrisk

Programme Period: 2012 —2016Total resources required US$ 17,759,492

Atlas Proposal ID: SAU1O/65588

Total allocated resources:Start date: lstApnl 2012o Government $ US$ 17,759,492

End Date 31st December 2016Previous unbudgeted S

PAC Meeting Date 24’ March 2012

IManaaement Arranaements NIM

Agreed by (SFDA):Dr. Mohammed AL Kan ha!

Executive President

Agreed by (UNDP):Kjshan KhodayUNDP Resident Representative a.i

BRIEF DESCRIPTION

Saudi Food & Drugs Authority (SFDA) completed the implementation of its first strategic plan (2007-2011).

Taking strategic planning as the planning approach to achieve its vision and mission, SFDA completed its

forward looking planning by developing its second strategic plan (2012-2016). SFDA has approached the

United Nations Development Programme (UNDP) to seek technical assistance and to jointly collaborate in

achieving its strategic goals set out in SFDA second strategic plan, based upon UNDP’s comparative and

competitive advantages in providing the required technical support.

in this context, the objective of this Project Document (PD) is to provide substantive support to SFDA,

through enabling SFDA to implement Food, Drugs and medical Devices strategic goals and initiatives laid

out in SFDA second strategic plan; as well as develop the required institutional capacity to discharge its

mandate and ultimately meet the national development plan’s aspiration to achieve its vision.

This joint project will benefit SFDA —in specific- in terms of institutional capacity development to support

SFDA in building broad and deep capabilities, help SFDA to ensure thoroughness, transparency, and

consistency in enforcement and communication, complete the coverage of all relevant areas as per SFDA’s

mandate, and finally develop systems and processes to improve pro-activity in addressing emerging risk.

This nationally executed project aims at providing advisory services, specialized experts, and administrative

support to SFDA. In the process, these activities will help in developing the authority’s policy, advocacy, and

executing capacity in the areas of food, drugs and medical devices.

II. SITUATION ANALYSIS

The 9tM National Development Plan (NDP; 2010-14) has the overall theme of sustaining the development

with a record $385 billion, 67% increase on 8’ NDP, targeted at improving standards of living, regional

development, economic diversification, knowledge-based economy and competitiveness, and human

resources including youth and woman. The NDP is based on the tenets of long-term strategy towards 2024

with the overarching target of having the kingdom as, “a developed, thriving and prosperous economy, built

on sustainable foundations’

As per the Ninth Development Plan, the plan envisages continued efforts to raise health standards for the

entire population, through expanding health facilities to cope with population growth, and improve

performance, quality of service and user satisfaction. The plan adopts a set of policies and programmes

directed towards furthering the role of cooperative health insurance to cover more segments of society;

achieving more decentralization in management and operation of health facilities; and supporting primary

healthcare facilities and their integration with secondary, specialist and referral care, and facilitating their

availability to the entire population in all regions.

SFDA developed its first strategic plan for the period from 2007 to 2011 with a vision “to be the leading

regional regulatory authority for food, drugs and medical devices with professional and excellent services

that contributes to the protection and advancement of the health in Saudi Arabia.” SFDA made some

distinguished achievements by implementing its first strategic plan. For the food sector, for example, one

main achievement is SFDA completed the inspection strategy on the borders of entry and also developed

the border inspection processes according to ISO 17020. An example of the Drug sector achievements is its

efforts to automate all drug and drug establishment processes using IT systems. Medical devices developed

the national register which contains a list of all medical devices and establishments which is the first to be

developed in Saudi Arabia.

In its continuing efforts to achieve its vision, SFDA recently developed its second strategic plan from 2012 to

2016 which focuses SFDA efforts on achieving high impact goals as set by its mandate. The second

strategic plan focuses mainly on building broad and deep capabihties. ensure thoroughness, transparency,

and consstency ri enforcement and communication, complete the coverage of all relevant areas as per

SFDAs mandate. and finally develop systems and processes to improve pro-activity in addressing emerging

risk.

III STRATEGY

The preliminary discussions between SFDA and UNDP focused on areas where UNDP could provide

substantive support in building SFDA capacity in implementing its second strategic plan. This project

document focuses on four major outcomes:

1 Support SFDA in building broad and deep capabilities, where UNDP competitive advantage in

building institutional capacity could support SFDA in enriching its expertise by attracting, retaining

and developing the appropriate human resources, enhance SFDA key internal tools and processes

to better support its mission, develop the required set of capabilities to take over key processes,

support Information Technology and Planning (ITP) and shared services sector in building their

capabilities

2. Support SFDA to ensure thoroughness, transparency, and consistency in enforcement and

communication, where UNDP competitive advantage in building institutional capacity could support

SFDA in Improving industry and consumer awareness and intra-agency cooperation through

interactive and coherent communication strategy, define internal control systems and institutionalize

accountability, align with relevant stakeholders on an efficient enforcement model

3. Support SFDA to Complete the coverage of all relevant areas as per SFDA’s mandate, where

UNDP competitive advantage in building institutional capacity could support SFDA in fulfilling

competencies and responsibilities outlined in mandate, also Optimize SFDA’s role regarding

inspection of local market food businesses and water bottling plants, build out pesticide standards

and related control infrastructure to cover the required scope as per SFDA’s pesticide mandate,

Implement effective processes to operationalize pesticide safety standards, reinforce safety of

drugs, bio-products, health, herbal and veterinary products across the value chain, pursue the

development of cosmetics standards and ensure the safety of cosmetics products, tighten SFDA’s

control over manufacturing , import and export of medical devices, and develop best practice

policies for specific / emerging product categories

4. Develop systems and processes to improve pro-activity in addressing emerging risk

Where UNDP competitive advantage in building institutional capacity could support SFDA in

establishing collaborative knowledge-sharing systems enabling early detection of potential hazards

to food and feed control system. fortify preparedness to emerging threats by discerning early on

market trends and emerging risks, and also Identify and swiftly act upon risks to patient safety

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V. MANAGEMENT ARRANGEMENTS

Execution ArrangementsThis project will be nationally executed through SFDA. SFDA will assume implementation

responsibilities with UNDP for recruitment of international and national advisors and other activities as noted

in the annual work plan. All project activities will be done through standard project board mechanism to

serve as a steering committee between SFDA and UNDP to ensure coherence of all activities under the

project. UNDP will provide technical support to all activities through the UNDP country office in Riyadh and

other reated resources as appropnate.

Project Board

The project board a the group responsbie for making on a consensus bas!s management decisions

for the project when guidance is required by the national project manager, including recommendation for

approval of project revisions.

Project reviews by this group are made on annual basis, or as necessary when raised by the national

project manager. The group is consulted by the national project manager for decisions, This group has two

roles, one for executive representing the project ownership to chair the group, and senior supplier role to

provide guidance regarding technical assistant to the project.

Project Organisation Structure

Project BoardSenior Beneficiaries Executi or Supplier

SFDA SFDA IJNDP

Project Assurance

Project assurance is the responsibility of each project board member, but the role can be delegated to

a staff within each organization. The project assurance role supports the project board by carrying out

objective and independent project oversight and monitoring functions, This role ensure appropriate project

management milestones are managed and completed. The Assistant Deputy Resident Representative

(ARR) UNDP Saudi Arabia will hold the project assurance role for the UNDP, and coordinator of SFDA

would undertake this role for SFDA. The national project manager and project assurance roles will never be

held by the same individual in SFDA.

National Project Manager

The national project manager will be appointed by SFDA and has the authority to run the project on a

day-to-day basis on behalf of the project board within the constraints laid down by the project board. The

national project manager is responsible for the day-to-day management and decision making for the project.

The project managers prime responsibility is to ensure that the project produces the results specified in the

project document, to the required standard of quality and within the specific constraints of time and cost. The

national project manager is appointed by SFDA through letter to UNDP. SFDA will also provide counterpart

staff, offices facilities and necessary office equipment (including computers) for project staff, and any other

project support facilities as deemed necessary.

Project Assistant

The project assistant will be appointed by SFDA with the responsibility to carry on the day- to- dayadministrative and financial project support.

Prior Obligations and Requisites

There are no prior Obligations and Requisites attached to this document

The schedule of Payments (USD) arid UNDP bank account details:

[ DATE AMOUNT (USD)

2012 $2,908,960

2013 1 $3,199,856

2014 $3,519,842

2015 $3,871,826

2016 $4,259,008

Total $17,759,492

1 The value of the payment, if made in a currency other than United States dollars, shall bedetermined by applying the United Nations operational rate of exchange in effect on the date ofpayment. Should there be a change in the United Nations operational rate of exchange prior tothe full utilization by the UNDP of the payment, the value of the balance of funds still held at thattime will be adjusted accordingly. If, in such a case, a loss in the value of the balance of funds isrecorded, UNDP shall inform the Government (SFDA) with a view to determining whether anyfurther financing could be provided by the Government (SFDA). Should such further financing notbe available, the assistance to be provided to the project may be reduced, suspended orterminated by UNDP.

2. The above schedule of payments takes into account the requirement that the paymentsshall be made in advance of the implementation of planned activities. It may be amended to beconsistent with the progress of project delivery.

3. UNDP shall receive and administer the payment in accordance with the regulations, rulesand directives of UNDP.

4. All financial accounts and statements shall be expressed in United States dollars.

5. If unforeseen increases in expenditures or commitments are expected or realized (whetherowing to inflationary factors, fluctuation in exchange rates or unforeseen contingencies), UNDPshall submit to the government on a timely basis a supplementary estimate showing the furtherfinancing that will be necessary. The Government (SFDA) shall use its best endeavours to obtainthe additional funds required.

6. If the payments referred above are not received in accordance with the payment schedule,or if the additional financing required in accordance with paragraph above is not forthcoming fromthe Government or other sources, the assistance to be provided to the project under thisAgreement may be reduced, suspended or terminated by UNDP.

7. Any interest income attributable to the contribution shall be credited to UNDP Account andshall be utilized in accordance with established UNDP procedures.

in accordance wtth the decismns and directives of UNDPs Executive Board:

The contribution shaH be charged:

(a) 5%1cost recovery for the provision of general management support iGMS) by UNDPheadquarters and country offices

8. Ownership of equipment, supplies and other properties financed from the contribution shallvest in UNDP. Matters relating to the transfer of ownership by UNDP shall be determined inaccordance with the relevant policies and procedures of UNDP.

9. The contribution shall be subject exclusively to the internal and external auditing proceduresprovided for in the financial regulations, rules and directives of UNDR”

VI. MONITORING FRAMEWORK AND EVALUATION

in accordance with UNDP programme and operations policies and procedures (POPP) outlined in the UNDP

user guide. the project will be monitored through the following:

within the annual cycle

on a quarterly basis, a quality assessment shall record progress towards the completion of key

resufts, based on quality criteria and methods captured in quality management table below,

• An issue log shall be activated in Atlas and updated by the project manager to facilitate tracking and

resolution of potential problems or requests for change

• Based on the initial risk analysis submitted (annex 1), a risk log shall be activated in Atlas and

regularly updated by reviewing the external environment that may affect the project implementation.

Based on the above information recorded in Atlas, a project progress report (PPR) shall be

submitted by the project manager to the project board through project assurance using the standard report

format available in the executive snapshot. Project lessons-learned log shall be activated and regularly

updated to ensure ongoing learning and adaptation within the organization, and to facilitate the preparation

of the lessons learned report at end of project.

Monitoring schedule plan shall be activated in Atlas and updated to track key management

actions/events

the annualccle

Annual review report. An annual review report shall be prepared by the project manager and

shared with the project board. As minimum requirement, the annual review report shall consist of the

Atlas standard format for the QPR covering the whole year with updated information for each above

element of QPR as well as a summary of results achieved against pre-defined annual targets at the

output level.

- Annual project review, Based on the above report, an annual project review shall be conducted

during the fourth quarter of the year or soon after, to assess the performance of the project and

appraise the annual work plan for the following year. In the last year. this review will be the final

assessment, This review is driven by the project board and may involve others as required. It shall

focus on the extent to whch progress is being made towards output, and that these rerr. a!n aligned

to appropriate outcomes.

Project Quarterly Progress Report (OPR) progress reports. Will be suDmitted by the National

Frolect Coordinator to Proiect Assurance and to the Outcome Board Such progress reports should

t: a cans ar ec s cs ea a “a son sn n o nsa

VII. QuALm’ MANAGEMENT FOR PROJECT AcTIvITY RESULTS

Replicate the table for each activity result of the A WP to provide information on monitoring actions based on

quality criteria. To be completed during the process “Defining a Project” if the information is available. This

table shall be further refined during the process “Initiating a Project”.

OUTPUT 1: Capacity of Institutional, indMdual and systems developed to serve processesand tools in all relevant sectors.

.

Activity Result 1 Ennch SEDA a expertise by attracting, retaining and developing the Start Date: 1 March 20112. appropriate human resources I

(Atlas Activity ID, j nd uate: 31 icc 2012

Purpose To Enrich SFDA ‘s expertise by attracting, retaining and developing the appropriate humanresources

Description Build SFDA capabilities to:

- Attract and retain best talent

-improve the expertise level of SFDA ‘s employees

- Conduct regular manpower planning studies as a basis for resource / budget allocation

-Ramp up expertise for scientists in biologics and emerging novel drug categories

-Ramp up expertise for inspectors in biologics and emerging novel drug categories

Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessmentactivity result will be measured? used to determine if quality criteria has of quality be performed?

been met?

Pre- and post- questionnaires or similar Questionnaires Annually

Expert feedback Expert Report Annually

OUTPUT 1: Capacity of Institutional, individual and systems developed to serve processesand tools in all relevant sectors.

Activity Result 2 Enhance SFDA key internal tools and processes to better support its Start Date: 1 March 201 12

(Atlas Activity ID)rnesion End Date: 31 Dec 2012

Purpose To Enhance SFDA key internal tools and processes to better support its mission

Description BuIo SFDA capabiities to:

- Es tablish integrated IT system throughout SFDA

- Achieve ISO accreditation for SFOA labs

- Support other departments to advance animal feed expertise and enhance control

- Integration of Feed Testing into Labs

-Streamline, calibrate and prioritize drug registration process

- Build up capacity / expertise of internal labs and contract private labs

- Ensure consistency and quality processes through SOPs and QMS

- Improve capabilities to monitor availability and security of drugs inside the KSA

- Improve evaluation and standard setting processes

- Euro and upgrade IT services n toe drug sector

- Launch Narcotics Druo System tNDS) and soclauze narcotics reaulations and qu:defines

- introduce a quality management system for the MD

OualttvCnte9a Qbauy Metrod - Date of Assessment

how/with what indicators the quality of the Means of verification, what method will be When will the assessmentactivity result will be measured? used to determine if quality criteria has of quality be performed?

been met?



OUTPUT 1: Capacity of Institutional, indMdual and systems developed to serve processesand tools in all relevant sectors.

Activity Result 3 Fully develop the required set of capabilities to take over key control Start Date: 1 July 20112(Atlas Activity ID)

processesEnd Date: 31 Dec 2012

Purpose To Fully develop the required set of capabilities to take over key control processes

Description Build SFDA capabilities to:

- Acquire the capabilities and resources to conduct controls

- Acquire the capabilities and resources to guide post-market inspections

- Acquire the capabilities and resources to conduct audits

Quality Criteria Quality Method Date of Assessmenthow’with what indicators the quality of the Means of verification, what method will be When will the assessmentactivity result will be measured? used to determine if quality criteria has of quality be performed?

been met?



OUTPUT 1: Capacity of Institutional, individual and systems developed to serve processesand tools in all relevant sectors,

Activity Result 6 Support TP and shared serces n buidng their caoabllties Start Date 1 March 201 12(Atlas Activity ID) End Date 31 Dec 2012

Purpose To Sapoort TP and snared servces N Duild’rig ir capacht’es

Description Build SFDA capabilities to

-improve The expertise ieveí of SPDA empio} ees ‘n fTP ana Shared Services

Conduct egular manpov’er pianning stad,es as a cass tor resource budget ai’ocation N fTPanc Shared Services

Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification what method will be When will the assessmentactivity result Nil’ be -nessured1 used to determine if quality criteria has of quality be performed°

been met7

[Pro-and post- quesonnaires or similar Quest,cnnaires Annually

Expert feedback Expert Report Annuai1y

OUTPUT 2: Communication strategy and control frameworks prepared and executed

Activity Result 1 mprove industry and consumer awareness and intra-agency Start Date: 1 March 20112

(Atlas Activity ID) eetbon through interactive and coherent communcahonEnd Date’ 31 Dec 2012

Purpose to Improve industry and consumer awareness and intra-agency cooperation through interactiveand coherent communication strategy

Description j Support SFDA to:

- Strengthen alliance with governmental ministries and agencies by ahaning on split of roles andresponsibilities

-Complete implementation of and full adherence to risk-based system across all departments

Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification. what method will be When will the assessment ofactivity result will be measured? used to determine if quality criteria has quality be performed?

been met?



Activity Result 2 Define internal control systems and institutionalize accountability Start Date: 1 March 201 12

(Atlas Activity ID) End Date: 31 Dec 2012

Purpose To Define internal control systems and institutionalize accountability

Description Support SFDA to:

- Go live with all registration processes and licensing systems for local food manufacturers,warehouses, distribution centres, and relevant food products

- Go live with all registration processes and licensing systems, and clearance systems for allforeign food manufacturers,, importers, and relevant products

- Institutionalize quality management systems across food sector departments


been met?



Activity Result 3 1 Align wth relevant stakeholders an an etfcient enforcement model Start Date: 1 July 20112


Purpose To A/ign with relevant stakenolders on an eff,cient enforcement model


- Design and enforce an appropriate fee structure aiming at maximum cost recovery fromregistration and approval activities

- E acage in close parrnershrp with other aqencies to ensure ccns’stent enforcement ofstandards and candies

Quality Criteria Quality Method ‘ Date of Assessmenthow/with what indicators The uafirv of the Means of verification, what methcd wi/be Wnen will ne assessment-

‘ ,ron,, cc en. cc so cc ‘- ‘-e c,.a e — c e—

Expert feedback Expert Report

OUTPUT 3: Standards, control systems and policies developed to cover food, drugs and medicaldevice

Activity Result 1 Continue to fulfill competencies and responsibilities outlined in mandate Start Date: 1 March 201 12


Purpose To Continue to fulfill competencies and responsibilities outlined in mandate


- Develop and rollout GCC Rapid Alert System for Food and Feed and implement recallthroughout KSA

-Establish private food lab registry database and licensing capability

- Establish export certification program

-Build laboratory for analysis and testing of pesticides


been met?



Activity Result 2 Optimize SFDA’s role regarding inspection of local

(Atlas Activity ID)bunesses and water bottling plants

Purpose To Optimize SFDA role regarding inspection of local market food businesses and water bottlingplants


- Fully transfer inspection of bottled drinking water and ice factories from MoMRA & MoC to SFDA

Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessment ofactivity result will be measured? used to determine if quality criteria has quality be performed?

been met?



Activity Result 3 mplement eftectve processes to oerationalize pesticide safety Start Date: 1 March 201 12(Atlas Activity ID) standards

End Date: 31 Dec 2012

Purpose To lrnplement effective processes to operationalize pesticide safety standards


- Develop, communicate and implement a streamlined process for registration / approval ofmaterials and products

Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessmentactivity result sill be measured? used to determine if quality ciiteria has of quality be performed?

been met?

Expert feedback I Expert. Report Annually

__-

-

-

___-

- ---- - ___J_______-


Activity Result 4(Atlas Activity ID)

Reinforce safety of drugs, bio-products, health, herbal and veterinary Start Date: 1 March 201 12products across the value chain

End Date: 31 Dec 2012

Purpose To Reinforce safety of drugs, bio-products, health, herbal and veterinary products across thevalue chain

Support SFDA to:

Complete the veterinary products regulatory framework

Design and implement an adverse events reporting system for pesticides

- Develop and complete the regulatory framework for pharmaceutical establishments

Approve and monitor clinical trials with clear and exhaustive guidelines and appropriateexpertise and capabilities

Quality MethodMeans of verification, what method will beused to determine if quality criteria hasbeen met?

Expert Report


Activity Result 5 Pursue the development

(Atlas Activity ID) of

Purpose To Pursue the development of cosmetics standards and ensure the safety of cosmeticsproducts


Finalize the structure of the cosmetics functions within SFDA

Pursue the listing and creation of standards for cosmetics products

-

how/with what indicators the quality of the Means of verification what method will beactivity result will be measured2 used to determine if quality criteria has

_________________

J been met?

LExpert feedback Expert Report

OUTPUT 3: Standards, control systems and pohces developed to cover food, drugs and medicaldevice

Activty Result 6

(Atlas Activity ID)

Purpose

1’ ghter SFDA s control v iia ufac. uring mport a d “xDort of f Start Date 1 March 201 12nedic.al devices

End Date 31 Dec 2012

To Tighten SFDA s control over manufactunng , import and export of medical devices

Description

Quality Criteriahow/with what indicators the quality of theactivity result will be measured2

Expert feedback

Date of AssessmentWhen will the assessmentof quality be performed2

Annually

_________

Quality Criteria Quality Method Date of AssessmentWhen will the assessmentof quality be performed?

Annually

ow/with what indicators the quality of the Means of verification what method will be When will the assessmentactivity result will be measured’? used to determine if quality criteria has of quality be performed’?

been met’?

Expert feedback —

______

Expert Report Annuafly


rActivity Result 7 Develop best prachce pohces for specbc emergng product Start DateS 1 March 20112

(Atlas Activity ID) categoriesjte’31Dec_2012 —

Purpose To Develop best practice policies for specific / emerging product categories


Draft, regulate & implement guidellnes for specific products

— Regulate & control the flow of special access medical devices

Implement & expand medical devices & establishments inspection program

- Introduce oversight over radiation emitting devices

Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessment ofactivity result will be measured? used to determine if quality criteria has quality be performed?

been met’?


OUTPUT 4: Systems and processes to improve pro-activity in addressing emerging risk developed

Activity Result 1 Establish collaborative knowledge-sharing systems enabling Start Date: 1 March 20112. early detection of potential hazards to food and feed control(Aflas Activity ID) system

Purpose To Establish collaborative knowledge-sharing systems enabling early detection of potentialhazards to food and feed control system


- Establish clear channels for feedback from external stakeholders. particularly private sector andconsumers

[ - Develop crisis management strategy to ensure emergency response preparedness

Quality Criteria Quality Method ‘I Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessment ofactivity result will be measured? used to determine if quality criteria has quality be performed?

been met?


Activity Result 2 Identify and swiftly act upon risks to patient safety Start Date: 1 March 201 12


Purpose To Identify and swiftly act upon risks to patient safety


- Develop a clear process for crisis management and ensure required capabilities are available

Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of Means of verification, what method will be When will the assessment ofthe activity result will be measured? used to determine if quality criteria has been quality be performed?

met?


OUTPUT 4: Systems and processes to improve pro-activity in addressing emerging risk developed

((SFDA finance team should discuss this with legal department after finalizing documentcontents))

VIII. LEGAL CONTEXT

This project document shall be the instrument referred to as such in Article 1 of the SBAA betweenthe Government of (country) and UNDP, signed on (date).

Consistent with the Article Ill of the Standard Basic Assistance Agreement, the responsibility forthe safety and security of the executing agency and its personnel and property, and of UNDP’sproperty in the executing agency’s custody, rests with the executing agency.The executing agency shall:

a) put in place an appropriate security plan and maintain the security plan, taking into accountthe security situation in the country where the project is being carried,

b) assume all risks and liabilities related to the executing agency’s security, and the fullimplementation of the security plan.

UNDP reserves the right to verify whether such a plan is in place, and to suggest modifications tothe plan when necessary. Failure to maintain and implement an appropriate security plan asrequired hereunder shall be deemed a breach of this agreement.

The executing agency agrees to undertake all reasonable efforts to ensure that none of the UNDPfunds received pursuant to the Project Document are used to provide support to individuals orentities associated with terrorism and that the recipients of any amounts provided by UNDPhereunder do not appear on the list maintained by the Security Council Committee establishedpursuant to resolution 1267 (1999). The list can be accessed via

This provision must be included inall sub-contracts or sub-agreements entered into under this Project Document.

IX. ANNEXES

Annex 1: Risk Analysis Log

Annex 2:Terms of Reference TOR for key project personnel should be developed and attached

Terms of Reference/Job Description for the respective long term advisors and short termxpertsiconsultants will be set Ut UOfl on- mencement of the project

An

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Annex 2

TERMS OF REFERENCESSFDA Phase II

Post Title:

Background

Scope of work and Objective

Methodology

IV. Qualifications and Experience Required:

V. Duration:

VI. Duty Station:

VII. Payments:

VIII. Timing:

expected cpd outcome sfda capacity development project id ...€¦ · saudi food and drug authority...

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