Conference Booklet April The Main Conference Rooms of Maritim Jolie Ville Hotels. Sharm El Sheikh - Arab Republic of Egypt

Transcription

1 Third Arab Conference for Future Begins Now Conference Booklet April 2018 The Main Conference Rooms of Maritim Jolie Ville Hotels Sharm El Sheikh - Arab Republic of Egypt

2 Third Arab Conference for Future Begins Now Organizers Participants Official Sponsor

3 H.E. Dr. Ahmed Emad Minister of Health and Population Arab Republic of Egypt Further to the fruitful cooperation between the Egyptian Ministry of Health and Population, the Arab Administrative Development Organization (ARADO), the Saudi Food and Drug Authority (SFDA), the Gulf Health Council for Cooperation Council States, and the General Secretariat of the League of Arab States in holding the 1st and 2nd Arab Conferences on, the Ministry is pleased to take part in organizing the Conference for the third time, under the title: (Future Begins Today), scheduled to be held during the period from 15 to17 April 2018, in Sharm El Sheikh. 2

4 Based on its accomplishments in the field of pharmaceutical policy, and in ensuring the availability and supply of drug through the Health Insurance Act -which will be issued soon- as well as its pioneering experience in the treatment of hepatitis C Virus, the Ministry was keen on co-organizing this Conference for third time. I am certain that this Conference is a top priority for the political leadership of Egypt, as it opens new horizons for effective relations, constructive partnerships, and fruitful cooperation between governmental organizations, scientific and research bodies, manufacturers, and distributors and enhances trust among them. I look forward to coming out with sound recommendations which guarantee regulatory compliance, nationalization of the food, drug, and medical devices industries, as well as ensuring their safety and quality in all Arab states. Finally, I would like to extend my sincere thanks and gratitude to the organizers of this Conference and the scientific committees. With all best wishes. 3

5 H.E. Prof. Hisham Bin Saad Al-Jadhey Chief Executive Officer of the (SFDA) Kingdom of Saudi Arabia President of the Conference Praise be to Allah, and prayer and peace be upon Prophet Muhammad and his family and companions. Building on the success of the 1st and 2nd Arab Conferences on Food, Drug, and Medical Devices, in promoting the concept of food, drug, and medical devices control, the 3rd Arab Conference on Food, Drug and Medical Devices is held in Sharm El Sheikh, Egypt, during the period from 29 Rajab to 1 Shaaban, (15 17 April 2018) under the title: (Future Begins Today). The Conference aims to shed light on the outcomes of the 1 st and 2 nd conferences and their impact on developing legislative and control processes concerning quality standards of food, drug, and medical devices and products in the Arab States. The Conference also discusses the challenges and difficulties faced by the regulatory and control bodies, the marketing agencies, and the manufacturers in the Arab world in these fields. 4

6 It further stresses the necessity of reconsidering the local regulations and systems for developing food, drug and medical devices industries in the Arab world to ensure local self-sufficiency and to be able to compete in the global market. Thus, we were keen in this Conference to bring together diverse expertise to discuss both Arab and international experiences to come out with Arab models that match the global market in quality and efficiency. We hope that this Conference though held in light of the global economic challenges and industrial blocs will reflect the spirit of challenge and optimism to overcome the obstacles facing the legislative and control systems in the Arab States, and help achieve supervisory excellence in food, drug and medical devices sectors, in a way that ensures thriving local industries to achieve safety and efficiency in food, drug and medical devices sectors, which will consequently impact the community welfare of the Arab citizen. Finally, I would like to extend my sincere thanks and gratitude to the Arab Administrative Development Organization (ARADO) League of Arab States, the Saudi Food and Drug Authority (SFDA), the Egyptian Ministry of Health, the Egyptian National Food Safety Authority (NFSA) and the Gulf Health Council for Cooperation Council States for their effective support and for providing all the potentials for the success of this conference, and I would also like to thank all the committees for their efforts, as well as various Arab States for working as a team for the Future begins Today. I ask God, the Almighty, to guide all efforts to the good of Man, and to help the participants benefit from this Conference. May the peace, mercy, and blessings of God be upon you. 5

7 H.E. Dr. Nasser Alqahtani Director-General The Arab Administrative Development Organization As part of our ongoing effort to develop coordination and communication mechanisms among all parties concerned with the safety of food, drugs and medical devices in Arab States to develop a realistic vision and solutions to the common challenges facing these industries in the Arab states, and based on the recommendations of the 2nd Arab Conference on Food and Drug we hold the 3rd Conference on. The Conference is considered a transformative paradigm shift in addressing food, drug, and medical devices issues and in applying the latest management principles and concepts to these three sectors, based on the importance of efficiently and effectively managing the research, production, marketing and control aspects. The conference is considered the largest Arab gathering which includes decision-makers, officials from ministries and departments of pharmaceutical affairs and medical devices, directors of pharmaceutical registration, food control bodies, nutrition centers and agricultural research centers from all the Arab States, as well as the representatives of relevant international organizations and institutions, academia, researchers, local and international food, drug and medical companies. 6

8 Perhaps one of the most strongly distinguishing feature of this Conference is holding - in addition to scientific sessions and the accompanying exhibition - meetings between governments representatives in the fields of food, drug and medical devices from diverse Arab states (G2G); meetings between governments representatives and representatives of companies, manufacturers and business community (G2B); and meetings between companies and business community (B2B) which will help open new horizons of cooperation, integration and partnership, in addition to promoting trust among them. In its endeavor to fulfill its mission, the Arab Administrative Development Organization holds this remarkable Conference as well as other distinguished events with the aim of enhancing administrative development throughout different sectors and services, including food and drug sectors that -if effectively managed-will contribute to the safety and security of citizens, thus resulting in the abundance of resources which will promote sustainable development in the Arab world. Finally, I would like to express my deep thanks and gratitude to his H.E. Dr. Ahmed Emad Eldin Rady-the Egyptian Minister of Health and Population- and H.E. Prof. Hisham Bin Saad Al-Jadhey-the Chief Executive Officer of the Saudi Food and Drug Authority(SFDA)-for their fruitful efforts, support, and sincere cooperation in organizing this Conference. I would like also to thank the General Secretariat of the League of Arab States (Health and Humanitarian Aid Department), the Gulf Health Council for Cooperation Council States, the Egyptian National Food Safety Authority (NFSA) and all participating parties. Last but not least, I would like to extend my sincere thanks and appreciation to all the members of the scientific and organizing committees, the experts, and scholars who participate with research papers to enrich the conference with their scientific and practical expertise, and to the representatives of the ministries and the participants from all the Arab and foreign countries, as well as the sponsors and exhibitors. May the peace, mercy, and blessings of God be upon you. 7

9 H.E. Mr. Sulaiman S. Aldakheel General Manger of Gulf Health Council s word Riyadh- KSA After the success of two cycles of (Arab Food and Drug Conference), a third round of the matter is launched under the name (future starts now) foreseeing a bright future for those vital sectors at all levels and fields, and aspiring for more unified efforts and roles coordination to achieve full integration with all concerned public or private sectors. Gulf Health Council participates in this conference after the success of the two previous cycles that had been held in Sharm-El-Sheikh. It represents a fundamental pillar of the Council s orientations towards supporting this kind of scientific and professional conferences. The outcomes and recommendations will reflect positively on various sectors within the Council including medicine group purchasing program and medicine and medical device central registration. Besides, Committee of Nutrition and Micronutrient and Gulf Unified Strategy for Food that lately resulted in Children Obesity Control Strategy. In addition, the support of health issues that concerns our societies and to contribute in achieving nutrition and medicine security through applying best practices. 8

10 The Gulf Health Council aspire the participation in events which represent a typical opportunity to move forward with more fruitful coordination and cooperation with the relevant bodies. We are honoured to participate in this conference with the Ministry of Health and Population of the Arab Republic of Egypt, the Saudi Food and Drug Authority, Arab Administrative Development Organization, the General Secretariat of the League of Arab States and the National Food Safety Authority in the Arab Republic of Egypt. The high goals that the conference seeks to be achieved, the scientific papers to be presented, the successful experiences that will be highlighted, and the specific initiatives that will emerge from this scientific and professional gathering, make this edition of the conference particularly important. Based on the outcome of this conference, relevant sectors will take practical steps, towards new and advanced stage in the fields of food, medicine and medical devices. At the end, I would like to take this opportunity to express my gratitude and appreciation to His Excellency Dr. Ahmed Emad Aldeen Radhi, His Excellency the CEO of the SFDA and the head of the conference Hisham bin Saad Al-Jadhey, General Director of the Arab Administrative Development Organization Ph.D. Nasser Ali Alqahtani. And I would like to extend my thanks for all the supporting and participating organizations. In addition to, all experts and specialists who will enrich the conference with their papers and specialized qualitative research. We are looking forward to achieve the desired goals and results and their impact that soon will be reflected on our Arab Society. 9

11 Introduction

12 Based on the recommendations of the 1 st and 2 nd Arab Conferences for Food, Drug, and Medical Devices, and with a view to boosting cooperation between the Arab Administrative Development Organization (ARADO), the Saudi Food and Drug Authority (SFDA), the Egyptian Ministry of Health, the Egyptian National Food Safety Authority (NFSA), and the Gulf Health Council for Cooperation Council States and believing in the importance of the exerted efforts to develop coordination and integration mechanisms between the bodies and agencies in the fields of food, drug and medical devices safety- both regionally and globally- to reach realistic solutions to the common challenges and draw a better future for food and drug production system in the Arab States and due to the importance of these critical sectors, the 3 rd Arab Conference on is held under the title: (Future Begins Today) during the period from 15 to 17 April 2018 in Sharm El Sheikh, Egypt. The conference aims to cast light on the importance of the legislative, regulatory and supervisory frameworks in ensuring food, drug and medical devices safety, and to present successful experiences in the Arab States, in addition to encouraging entrepreneurship, innovation and creativity. The conference also seeks to develop a vision that helps achieve food and drug security in Arab states. Furthermore, it highlights the latest technologies in manufacturing and producing food, drug, and medical devices, and launches an Arab network for drug and medical devices that facilitates the exchange of information between the supervisory agencies, strengthens cooperation and integration between the government and the private sector, and fosters trust between the supervisory agencies, manufacturers and producers. In order to achieve these objectives, the scientific Committee invites a number of experts, scholars, and specialists the fields of in food, drug, and medical devices from Arab and non-arab States to share and exchange their experiences. 11

13 Objectives of the Conference:

14 1. To indicate the importance of governance (legislative, regulatory and supervisory frameworks) to ensure the safety and control over food, drug and medical devices. 2. To support the nationalization of food drug and medical devices production. 3. To build a Sharing Platform to share and exchange the successful experiences among the Arab States. 4. To achieve food and drug security, accessibility and availability in the Arab States. 5. To create a paradigm shift in the cooperation, integration and partnership between the government and the private sector and boosting trust between them. 6. To encourage innovation, creativity, and entrepreneurship. 7. To highlight latest trends and technologies in the production of food, drug and medical devices. 8. To remove technical and health-related obstacles, which are not science-based nor meeting the universal standards, facing the intraregional Arab trade of food. 9. To harmonize drug supervisory systems and standardize drug registration mechanisms in Arab states. 10. To protect the Arab consumer through legislative frameworks and supervisory systems that ensure the safety of food, drug and medical devices. 11. To build an Arab network for drug and medical devices. 12. To implement the recommendations of the 1 st and 2 nd conferences. 13

15 The Features of the Third Arab Conference on (Future Begins Today) The 3 rd Arab Conference on Food and Drug is the first of its kind in the Middle East, which aims to promote the Arab efforts in order to ensure the safety of food, drug and medical devices. Driven by their leading roles in shedding light on the most important topics that aim at uplifting nations and securing a healthy life for Arab citizens, the Arab Administrative Development Organization, the Egyptian Ministry of Health and Population, and the Saudi Food and Drug Authority took on the challenge of organizing the conference periodically after the success of the first two conferences in 2013 and 2015, and gathering the experts in this field to come out with recommendations that ensure implementing its objectives. The most important features of the conference are: A. This conference is the largest Arab gathering in the field of food, drug and medical devices. It includes four integrated categories: 1. Decision Makers - Officials, leaders and managers of pharmaceuticals and drug registration. - Arab and global food organizations, and food control officials from ministries of agriculture, trade and industry in the Arab States. 14

16 2. The Relevant International Organizations and Institutions - Codex Alimentarius Commission (CODEX) - Food and Agriculture Organization (FAO) - World Trade Organization (WTO) - World Health Organization (WHO) - United Nations Industrial Development Organization (UNIDO) - United States Food and Drug Administration (FDA) - Food and drug Arab federations and agencies - General Secretariat of the League of Arab States (Health and Humanitarian Aid Department) - Ministries of Health in Arab countries - Gulf Health Council for Cooperation Council States 3. Academia and research centers. 4. Business community. 5. Food manufacturers and producers. 6. Manufacturers and producers of drug and medical devices. 15

17 B. The conference opens networking channels with drug control and supervision officials, drug registration officials in ministries of health as well food quality control officials in the bodies and ministries of agriculture, trade and industry in the Arab states. It also raises manufacturing and marketing issues, and comes out with recommendations that contribute to solving them. C. The conference open horizons of cooperation, investment, and market penetration, for the participants, sponsors, and exhibitors, as well as examining the opportunities and mechanisms of forming strategic alliances between the Arab manufacturers of food and drug, and the importance of merge takeover & technology transfer in boosting the nationalization of the Arab food and drug industry, and creating a paradigm shift in the cooperation, integration and partnership between the government and the private sector and fostering trust between them. D. The Conference Includes: 1. An accompanying exhibition of the products and the newsletters of the sponsors. 2. Scientific sessions and applied research to demonstrate the latest trends in the field of food and drug. 3. A panel to present the successful Arab experiences in establishing food and drug authorities, in order to share them with the Arab states. 4. Meetings between the representatives of the Arab Governments. (G2G) 5. Meetings between the representatives of Governments, the manufacturers and the producers. (G2B) 16

18 Target Audience 1- General Secretariat of the League of Arab States 2- The Egyptian Food Safety Authority (Health and Humanitarian Aid Department) 3- Gulf Health Council for Cooperation Council States 4- Ministries of Health in the Arab states 5- WHO Regional Office for the Eastern Mediterranean (WHO EMRO) 6-7- Food and Agriculture Organization of the United 8- Nations (FAO). 9- Arab Union of Manufacturers of Pharmaceuticals 10- and Medical Appliances 11- Ministries of Agriculture in Arab states 12- The Faculty of Pharmacy Cairo University U.S Food and Drug Administration (FDA) Jordan Food and Drug Administration (JFDA) Ministries of Health in Arab states 13- Import Control Organizations 14- Scientific Research Ministries, Agencies and Centers in Arab states 15- Arab Organization for Agricultural Development Faculties of Pharmacy, Veterinary Medicine and 18- Agriculture in Arab states 19- Agriculture Institutions and Centers in the Arab States Nutrition Institutes Union of Arab Industries The Arab Pharmaceutical and Medical Supplies 26- Companies 27- Food Companies and Factories Agricultural Development and Land Reclamation 30- Companies Regulatory Bodies in Arab States Customs Departments in Arab states General Union of Chambers of Commerce, and Industry Organizations concerned with medical devices and products Beverages and Juice Companies and Factories Fisheries and Fish Farming Companies Livestock Development Companies Food Packaging Companies 17

19 Conference Themes Food Sector Theme1: Governance and Food Production Management - Consistency of Arab and international legislation in the field of food safety. - Control of Halal Food. - Control of Organic Products. - Control the handling of feed to ensure the safety of food. Theme 2: The role of international food organizations in the governance of food production and processing - Codex Alimentarius Commission (CODEX). - Food and Agriculture Organization (FAO). - World Trade Organization (WTO). - World Health Organization (WHO). - United Nations Industrial Development Organization (UNIDO). Theme 3: Successful stories (experiences) in Arab and foreign countries - Experience of the Saudi Food & Drug Authority (SFDA). - Experience of the National Food Safety Authority of Egypt (NFSA). - Experience of the Abu Dhabi Food Control Authority (ADFCA). 18

20 - Experience of the National Office of Sanitary Safety of Food Products of Morocco (ONSSA). - Experience of the Jordan Food and Drug Administration (JFDA). Theme 4: Recent trends in food production and processing techniques - Fighting fraud in the food industry. - Food inspection and electronic control. - Functional and special foods. - Genetically modified foods (what they have). Theme 5: the Arab efforts to keep pace with the global regulations in the field of food safety - Arab Rapid Alert System for Food and Feed. - Arab Risk Assessment System. - Food inspection and certification systems in the Arab region. - Assessment of the capacities of Arab food safety systems. Round table meetings between representatives of Governments, manufacturers and producers: - Meetings between government representatives in Arab countries (G2G). - Meetings between representatives of governments, manufacturers and producers (G2B). 19

21 Conference Themes Drug Sector The first session (The governance and pharmaceutical regulatory authorities) - Harmonization of pharmaceutical legislation, regulations and technical guidelines among the Arab countries. - The importance of establishing uniform rules for drug registration and mutual recognition between Arab countries. - Updating the legislation governing biosimilars. - The pivotal role of the information technology and automation in the harmonization (consolidation) and development of pharmaceutical registration. The second session (Industrial localization and technology transfer) - Pharmaceutical manufacturing policies in Arab countries. - Develop legislative incentives to encourage pharmaceutical manufacturing. - The future and ambitions of manufacturing of pharmaceutical raw materials in the Arab countries. - Pharmerging market and therapeutic groups. The third session (International and regional success stories) - Egyptian success story in the eradication of virus C. - Saudi success story in pharmaceutical track and trace. - Jordanian success story in expanding the pharmaceutical exports. - A success story from the European commission. 20

22 The forth session (Cosmetics between luxury and actual need) - The importance of cosmetics market in the Arab countries. - Safety aspects of cosmetics. - Development and harmonization of the control mechanisms for cosmetics. - Therapeutic applications of cosmetics. The fifth session (Arab drug security, access and availability) - Drug safety standards. - The track and tracing system in combating drug counterfeiting. - The role of regulators and pricing policies in achieving Arab drug security. - The guarantees for sustainable drug availability and accessibility (health insurance laws). Round table discussions (Regulators Vs producers and manufacturers) - Governmental representatives (regulators) meeting (G2G). - Governmental representatives (regulators) Vs producers and manufacturers (G2B). 21

23 Conference Themes Medical Devices Sector First Track: Governance of Medical Devices (Working to Harmonize) - Impact of regulations on importing and manufacturing medical devices - Update on the status of medical devices Regulations in the Arab World - Building a regulatory framework for medical devices (WHO Workbook, AHWP playbook) - Global and regional harmonization initiatives (IMDRF, AHWP) Second Track: Elements of Regulatory Framework for Medical devices - The essential principles of safety and effectiveness for medical devices and the role of standards - Quality Management Systems (QMS) for manufacturing and importing medical devices - Post market controls on medical devices - Concept of reliance and mutual recognition between regulatory authorities as a solution for resource constraints. Third Track: Successful Models in Regulating Medical Devices - New european medical devices directive. - Saudi FDA experience in building a regulatory framework for medical devices. - Listing of medical devices in Egypt. - Listing of medical devices Tunisia. 22

24 Fourth Track: Practical Applications in Medical Devices Regulations - Nomenclature of medical devices (UDI, GMDN, and UMDNS) - National center for medical devices reporting in Saudi FDA - National dose reference level in diagnostic and therapeutic radiology departments - Impact of post market surveillance on pre-market approvals Fifth Track: Special Topics in Medical Devices Regulations - MD regulations as basis for Health Technology Assessment - Conformity Assessment Bodies (CAB) role in MD regulation (MDR) - Cyber security for medical devices and equipment - Local manufacturing and the challenge of compliance - Clinical trials for medical devices framework Round Table Discussions (Regulators and Industry) Regulators Meetings (G2G). Regulators Industry Meetings (G2B). 23