برنامج حفل الافتتاح           البرنامج العلمي للندوة       التوصيات Recommendations

برعاية معالي وزير الصحة بالمملكة العربية السعودية الدكتور/حمد بن عبدالله المانع وضمن جهود المكتب التنفيذي العلمية والتطويرية ولأهمية متابعة جودة الدواء لمنع الاصابة أو الإعاقة أو الوفاة نظم المكتب التنفيذي الندوة الخليجية الثالثة في هذا المجال وذلك تحت شعار :

 (وضع نظام لرفع التقارير حول جودة الدواء)

(Drug Quality Reporting System)

وذلك خلال الفترة 8-9 صفر 1428هـ  الموافق 26-27 فبراير 2007م   في الرياض - فندق مادرين كراون (فهد كروان سابقاً)

 برنامج حفل الافتتاح :

 11.00   -   11.05                السلام الملكي  

 11.05   -   11.10                 قرآن كريم

 11.10   -   11.20                كلمــــة الشركــــة الداعمــة

الدكتور/ أنطوان مخيبر - مدير عام الشركة لأفريقيا والشرق الأدنى   

 11.20  -    11.30                كلمة مدير عام المكتب التنفيذي   

الدكتور/ توفيق بن أحمد خوجة                         

11.30   -    11.40             كلمة راعي الندوة معالي وزير الصحة  

الدكتور/ حمد بن عبد الله المانع   

11.40  -     11.50                تسليم  الجوائز والدروع التذكارية 

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البرنامج العلمي للندوة :

FIRST DAY

FIRST SESSION

09.00 – 12.30     Chaired By Dr. Tawfik A M Khoja 

09:00 - 09.30      Recitation of Holy Qur’ an  

                            Welcome                                                                        

                            Dr. T. Khoja - GCC

90:30 - 10:15     Counterfeit medication, The Scope of the problem causes, etc,

                           WHO Perspective                     

                           Dr. Zafar Mirza, EDB WHO/EMRO

 10:15 - 10:30    Coffee Break 

10:30 -11:30      Combating counterfeit drugs, Industrial perspective          

                           H. De Jong - Servier

11:30 - 12:00     Discussion 

12:00 - 13:30    Prayer + Lunch

SECOND SESSION

13.30 – 15.30       Chaired By Dr. Zafar Mirza 

13:30 - 14:30       Combating counterfeit drug by, Enhancing regulatory and enforcement

                             Dr. T. Kubic – PSI 

14:30 -15:00        Counterfeit medicine:

                            Survey on medications,

                            Brought by the pilgrims to Saudi Arabia                

                            Dr. S. Bawazir – SFDA

15:00 - 15:30         Discussion

SECOND DAY

THIRD SESSION

9.00  -  12.00        Chaired By Dr. M. Meshal 

09:00 - 09:30      The need for drug quality, Reporting system

                            Dr. A. Charvill

09:30 - 10:30      How to set up a Drug Quality, Reporting System

                            Dr. A. Charvill

10:30 - 11:00       Discussion

11:00 - 11:15       Coffee Break

11:15 - 12:00      Raw Material and drug Quality                               

                            Dr. H. Muti

12:00 - 13:00     Lunch and prayer

FOURTH SESSION

13.00  -  17.00      Chaired By Dr. S. Bawazir – SFDA

13:00 - 13:30      GMP and drug quality                                                     

                            Dr. M. Meshal

13:30 - 14:30       Drug Quality: a GCC perspective

                            (KSA, Kuwait, Bahrain, Qatar, UAE, Oman, Yemen)

14:30 - 15:00       Recalling System

                            Pharmaceutical company perspective

                            Dr. C. Sauveur - Servier           

15:00 - 15:30      Recalling system                                                              

                            Government Perspective                             

                            Dr. A. Charvill

15:30 - 16:00       Discussion

16:00 - 17:00       Recommendations

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Declaration Of Riyadh

At the GCC Drug Quality Symposium

Dated 26-27 February, 2007

Hotel Madareem Crown, Riyadh

Kingdom of Saudi Arabia  

Counterfeit Medication

 After discussion, the panel formalized a declaration as under:

 Counterfeit medicines are a serious and growing problem and are not limited to one or few countries. The strategy to overcome this problem requires actions at national, regional and global levels. Following recommendations are made from this perspective; 

1. The office of the Executive Board of Health Ministers Council for Gulf Cooperation Council States should initiate action so as to actively engage themselves with worldwide activities like IMPACT (International Medicinal Products Anti-Counterfeit Task Force). The office of the Executive Board of Health Ministers Council for Gulf Cooperation Council States should take the lead to address this problem at the next meeting of Arab Health Ministers.
2. National pharmacovigilance infrastructure and implementation needs to be established and/or strengthened in the GCC member countries. The concept of pharmacovigilance is a broader concept than just ADR reporting and should be operationalized in this sense.
3. Develop network of Single Points of Contact (SPOC) per sector e.g. DRA, inspection, police, customs, industry to allow for communication and immediate action
4. Develop network of Official Medicines Control Laboratories (OMCL) and specific anti-counterfeit expertise.
5. Make an inventory of needs for Training and Education of officials e.g.; police, customs, prosecutors, as to the specifics of medicine counterfeiting.
6. Define Regional and National priorities based on risk analysis.
7. A multi-stakeholder national level committee should be formed involving at least MOH, customs department and law enforcement agencies to develop specific national strategies and operations to combat counterfeit problems.
8. A national level study should be launched to assess the situation with regard to counterfeit medicines
9. A three level approach should be adopted for collaborating with other countries in terms of joint action and information sharing
   1. At GCC level
   2. At EMRO level
   3. At global level

Drug Quality

Drug Quality Reporting System 

1.       Each state should establish a drug quality reporting system as a part of post-marketing surveillance programme .

2.       Encourage the Health Professionals (pharmacists, nurses, physicians) and patients to report any irregularity in drug quality such as;

·         Wrong data on labels, packaging, leaflets

·         Lack of efficacy

·         Packaging labeling

·         Contamination

·         Product mix-up

·         Re-labelling error

·         Non compliance to product specifications

·         Non compliance to specification (analysis)

3.       Each country should establish a recalling system that responds to the needs of protecting the public from defective pharmaceutical products.

Quality of Active Pharmaceutical Ingredient (API)

 1.       Drug regulatory authorities must ensure that drug master file (DMF) must be submitted along with registration file of the Pharmaceutical product.

2.       Drug regulatory authorities should request GMP certificate of API manufacturers and that certificate of suitability (COS) is submitted along with registration file.

3.       Drug regulatory authorities are encouraged to train their staff in process validation and laboratory analysis.

 Good Manufacturing Practices (GMP) 

1.       Drug regulatory authorities should develop experienced inspectors in sufficient numbers that will meet the high demand for conducting Good Manufacturing Practice Inspection to ensure compliance of manufacturers of pharmaceutical products.

2.       Drug regulatory authority should inspect pharmaceutical manufacturers at regular intervals to ensure their compliance with GMP regulations. 

Storage and Transportation

Each GCC country should develop and enforce a system that ensures the proper storage and transportation of pharmaceutical products.