FIELD VISITS

WHO Pre-Qualified Manufacturing

Facilities

Technical Partners:

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29th Jan – 02nd Feb, 2018GOA, INDIA

INTERNATIONAL WORKSHOP ON

QUALITY ASSURANCE IN PROCUREMENT & SUPPLY

CHAIN MANAGEMENT

*Board Member *Administrator

COURSE OBJECTIVE

• Get an insight into the fundamentals of pharmaceutical quality inProcurement and Supply Chain

• Determine how to budget for quality assurance activities in theprocurement budget - analyse the relevance of pharmaceutical referencestandards and their impact on pharmaceutical prices

• Gain hands-on experience in observing and understanding Quality Control• Gain experience in working knowledge of various instrumentation required

for analytical testing of pharmaceuticals (GLP)

WHO SHOULD ATTEND?

The course is a combination of policy, strategy, planning andimplementation. The course provides an accelerated but solid overviewof Quality Assurance in Procurement and Supply Chain.The course is targeted at:• Pharmacists, chemists, microbiologists, public health professionals,

medical doctors, working in public health programs and industry(government, NGOs, civil society, academia, industry)

• Procurement and supply chain professionals working in procurement,warehousing, distribution, policy, planning, quality assurance

• Physicians and healthcare professionals working in HIV, TB, malariaand RMNCH

• Community-based organisations and treatment activists

▪ Course fees: US$ 2100 which includes:• One week face-to-face training in Goa + 2 weeks preparatory work• Certificate from Empower School of Health• Local transportation for field visits• One-year technical assistance

Does not include – International travel, airport transfers, dinner andaccommodation

REGISTRATIONS

▪ Registration deadline: 10th January, 2018▪ To apply, please click here▪ Email us at: training@empowerschoolofhealth.org

COURSE FEE

ABOUT THE COURSE

“Empower’s training on promoting access to medicine was acomprehensive training package enabling the staff responsiblefor PSM of medicines and medical equipment by buildingcapacity in access to medicines. It was an excellent training andthe choice of training venue gave us the opportunity tounderstand the functioning of various UN agencies.”

Kyaw Kan Kaung, Director, Ministry of Health, Myanmar

“Very nice experience to meet with different people fromdifferent countries, highly impressed with the teachingmethodology of Empower faculty. A well-organized trainingand excellent hospitality by Empower.”Dr. Sucheta, Indian Pharmacopoeia Commission, MoH, India

TESTIMONIALS

“This has been a highly informative week. The practical exerciseand site visits were essential to ‘bringing it all together’. Thankyou for excellent quality professors and team.”Justina Ogechi Ehirim, Procurement Officer, WHO SEARO,India

“The workshop organized by Empower was exceptional. Thecourse materials and additional resource readings wereexcellent covering the full spectrum of the medical commoditysupply system - from product selection through rational use ofmedicines. The knowledge and experience of the instructorswas beyond expectations.”Kathleen Downs, Pharmacist & Medical CommoditiesTechnical Advisor, OFDA, USAID, USA

“This course was one of its kind in my career and hopefullywill add value to my management and leadership skills inSouth Sudan. I have learnt a lot and now I am able to deliverand ensure that the people of my country have access toquality, safe and effective health product.”Dr. Moses Deng, Director General, Ministry of Health (SouthSudan)

COMPREHENSIVE QUALITY ASSURANCE STRATEGIES ACROSS ENTIRE SUPPLY CHAIN

Procuring good quality pharmaceuticals

How to ensure you are buying good quality products

Maintaining quality How to ensure the products do not

deteriorate during storage and transport

Comprehensive QA systemsHow to ensure total product quality

approach - from ‘production to patient’

PHARMACEUTICAL PRODUCT QUALITY :

Introduction to Quality Assurance of Pharmaceuticals and Health Commodities: Difference between QA and QC ; Prevalence of poor

quality products; Major categories of QA.

Product Quality Standards: Lack of global QA standards; need to clearly define quality standards; understanding Pharmacopeial

standards; therapeutic window; bioavailability considerations; product stability; consequences of poor quality (above topics will include

examples of pharmaceuticals from HIV; TB; malaria; reproductive health products; antibiotics; anti-fungal and drugs for NCDs).

RATIONAL QUALITY ASSURANCE SYSTEM :

Risk Assessment and Risk Management: Identifying critical items; focusing on high risk areas.

Three Tier System Approach (explaining why QA is NOT just lab testing): Inspections and sampling (product certificates; batch

certificates); Screening (verifying quality); Analytical testing (different types of lab tests).

NATIONAL QUALITY ASSURANCE PLANS AND MANUAL :

QA at the National Level: National QA policy - key decisions; QA plan - key approaches; QA manuals/SOPs – staffing and training.

Specifics of QA Implementation: Rates of sampling, inspections, screening, analytical testing; Chain of custody; who will do what?

Product recalls; Monitoring indicators; Sampling and visual inspections; Minilab screening testing; Preparing QA manuals and plans.

FIELD VISITS TO WHO PREQUALIFIED MANUFACTURING FACILITIES

COURSE TOPICS

Prof. Paul S. Lalvani: Director of Empower School of Health, former head of Global Fund’s department of Procurement and Supply Chain Management,advisor to Gates Foundation, World Bank, WHO, and various Ministries of Health

Prof. Andy Barraclough : Director, Empower School of Health, Professor of Public Health Procurement & Supply Chain Management; GMS certifiedGlobal Fund PSM consultant; has over 25 years of experience of working with major International Funding Institutions and bilateral

Dr. Denis Broun: Ambassador, Permanent Representative of PPD to UN and International Organization in Geneva; Former Executive Director UNITAID,former Regional Director UNAIDS

Dr. Alassane BA: CHMP, Director; combines a strong experience of GMP Guidelines, National Pharmaceutical Policy, Pharmaceutical Regulations, dealingwith international institutions, NGOs and endemic countries in the field of public health

Ms. Sakhile Dube-Mwedzi: She has over 15 year of experience in global pharmaceutical quality assurance. She is a proficient GMP inspector and MAassessor

COLLABORATING PARTNERS Empower School of Health's vision is to empower lives by promoting universal access to health and education. We work with healthprofessionals from more than 30 countries to strengthen institutional capacity of global health programs. We also conduct assessments, researchand provide advice to donors, governments and UN agencies on sourcing, logistics, pricing, quality, drug regulations, catalyzing local productionand technology transfer. We offer intensive programmes (online, classroom and onsite) for participants/organizations seeking a morecomprehensive understanding in a specific area of expertise.

Pharmaceutical Export Promotion Council of India (Pharmexcil) is the authorized agency of the government of India (under Ministry ofCommerce) for promotion of pharmaceutical exports from India. It was set up under the provisions of Foreign Trade Policy by the Ministry ofCommerce and Industry in May 2004.

CHMP is a not-for-profit humanitarian organization based in France. It is a WHO Prequalified Laboratory and is recognized as a centre ofexcellence in the areas of pharmaceutical quality assurance and combating the proliferation of falsified health care products. CHMP worksinternationally to strengthen international institutions, Ministries of Health and non-governmental organizations.

The People that Deliver Initiative (PtD) was established in 2011 as a global partnership of organizations focusing on professionalization of supplychain personnel by advocating for a systematic approach to HR for supply chain management. PtD envisions a world where health supply chainworkforces are empowered and equipped to optimize health outcomes by improving access to health commodities.

IAPHL India Chapter, managed by Empower, promotes the IAPHL mission of supporting the professionalization of supply chain officers andmanagers in India and others working in the field of public health logistics and commodity security. The objective of this chapter is to promotethe importance of “Supply Chain” in public health programs in India.

For more details on the Workshop, Contact - Course Counselor

training@empowerschoolofhealth.org+91 95.99.83.50.01

www.empowerschoolofhealth.org

For aspirants who wish to pursue an advanced course in PSM, Empower offers anonline Post-Graduate Diploma in Global Health Procurement & Supply ChainManagement, in collaboration with Kent State University, Ohio.For more details, follow this link: CLICK HERE

SCHOLARSHIPS AVAILABLE

CONTACT US

KEY ADVISORS/LECTURERS

…and several other faculty of international repute