First Arab Conference

“ Regulatory Control on Food, Drug & Medical Devices

…. Ambitions and Challenges”

Drug Sector Program

Time Subject

9:00-11:00 Opening session and Exhibition opening

11:00-11:30 Coffee Break

Day One

Chairman: Prof. Mohammed Taj Aldein

Time Subject Spokesman

First Session: Some experiences of drug regulations

11:30-11:50 The Saudi Food and Drug Authority experience

Prof. Saleh Bawazeer Vice Executive President for Drug Sector

SFDA-KSA

11:50-12:10 Concept of Patient Safety in Pharmaceutical Care

Dr. Tawfiq Khoja

Director General Executive Board,

Health Ministers Council for Cooperation

Council

12:10-12:30 Egyptian Drug Control Authority experience

Dr. Faten Abdel-Aziz Fathalla

Assistant Minister for Pharmaceutical Affairs

Ministry of Health

12:30-12:50 Situation of Medicine Regulatory Authorities in

the Eastern Mediterranean Region

Dr. Mohamed Bin Shahna

Regional Advisor

World Health Organization

12:50-1:10 Immunogenicity With Biologics and Bio similar

Drug.

Prof. Huub Schllekens

Professor Of Pharmaceutical Biotechnology

at Utrecht University Netherlands

1:10-1:30 Discussion

1:30-2:30 Praying & Lunch

Chairman: Prof. Saleh Bawazeer

Second Session: Drug pricing policies

2:30-2:50 WHO studies on drug prices Dr. Mohamed Bin Shahna

Regional Advisor

World Health Organization

2:50-3:10 The Saudi experience in drug pricing Ph. Fahad Al Ntify

Supervisor drug pricing and economy

department- SFDA-KSA

3:10- 3:30 The Egyptian experience in drug pricing

Dr. Hassan Lashin Planning &Drug Policies Director &Pricing

Department - Central Administration for

Pharmaceutical Affairs

3:30-3:50 Drug prices unification in GCC

Dr. Mohammed al-Haidari

Health Ministers Council for Cooperation

Council

3:50-4:10

Discussion

First Arab Conference

“ Regulatory Control on Food, Drug & Medical Devices

…. Ambitions and Challenges”

Drug Sector Program

Day Two

Chairman: Dr. Mohamed Bin Shahna

First Session: Drug counterfeit and its impact on the public health

9:00-9:20 The Saudi experience in PMS Ph. Mohammed Dahhas

Executive Director for enforcement and

compliance-SFDA

9:20-9:40 Morocco experience in fighting drug Counterfeit.

Dr.Abdelhakim Zalim

Docteur en pharmacie

Pharmacien Inspecteur Chef de Division de la pharmacie

Kingdome of Morocco

9:40-10:00 Republic of Iraq experience in fighting drug

Counterfeit.

Prof. Dr. Sabah N. Alwachi

Professor of Physiology

Head of Biology Department

College of Sciences

University of Baghdad

10:00-10:20 Drug manufactures role in fighting Counterfeit.

Dr. Khalid Suliman AL-Shammari

Director Products Development & Regulatory

Affairs-SPIMACO

Member of the National Committee of

Pharmaceutical Industries in the Council of

Saudi Chambers

10:20-10:40 Discussion

10:40-11:00 Coffee break

Chairman: Dr. Mohammed Abduljwad

Time Subject Spokesman

Second Session: Drug registration mechanisms

11:00-11:20 pharmacological Central registry

Dr. Mohammed al-Haidari

Health Ministers Council for

Cooperation Council

11:20-11:40 Drug registration mechanisms in Egypt Dr. Basant Ahmed Hassan Front Office Manager of Human

Registration department

11:40-12:00 The Saudi Drug Registration (SDR) experiment.

Ph. Hassaan S. Alwohaibi

Manager of Regulatory Affairs

SFDA

12:00 -1:20 Discussion

1:30 – 2:30 Praying & Lunch

Chairman: Dr. Abdullah Zain Alabdien

Third Session: Countries experiences in the Common Technical Document (CTD)

2:30 – 2:50 The Saudi experience in the Common Technical

Document (CTD).

Ph. Hassaan S. Alwohaibi Manager of Regulatory Affairs

SFDA

2:50–3:10 Egyptian experience in the Common Technical

Document (CTD)

Dr. Mona Salih Head of Biologicals Registration

Directorate Central Administration for

Pharmaceutical Affairs

3:10 -3:30 Arab Pharmaceuticals Manufacturers’ Perspective

about the Common Technical Document (CTD)

Dr. Abullah Al Mohizea Tabuk Pharmaceutical Manufacturing

Company

3:30-3:4:00 Discussion

End of Day Two

First Arab Conference

“ Regulatory Control on Food, Drug & Medical Devices

…. Ambitions and Challenges”

Drug Sector Program

Day Three

Chairman: Dr. Susan Bint Ahmed Jaafar

Time Subject Spokesman

First Session: Drug manufacturing and Bioequivalence

9:00 – 9:15 Requirements to join the PIC / S and Inspection

rules on pharmaceutical factories

Ph. Mohammed Dahhas

Executive Director for enforcement and

compliance-SFDA

9:15 – 9:30 Developing new Technologies in the field of

Industrial Pharmacy

Prof. Dr. Nazik Elgindy

Head of dept. of Industrial Pharmacy

Faculty of Pharmacy, Alexandria University

Egypt

9:30 – 9:45 Saudi Arabia experience in Bioequivalence

Dr. Fahad Al Jenoobi Executive Director of Product Evaluation

and Standards Setting

9:45 – 10:00 View of Bioequivalence studies centers.

Dr. Naji M. Najeeb

Professor of Pharmaceutics

International Pharmaceutical Research

Center (IPRC)

Amman – Jordan

10:00-10:15 Clinical studies in Tunisia and the Maghreb

Dr. Mohammed Elheltiti

Ministry of Health

Tunisia

10:15 -10:30 Discussion

10:30- 11:00 Coffee break

Chairman: Dr. Fahad Al Jenoobi

Second Session: Drug safety and Awareness

11:00- 11:20 Oman's experience in pharmacovigilance

Dr. Susan Bint Ahmed Jaafar

Director general of Pharmacy and Drug Control Department

Ministry of Health

11:20 – 11:40

Saudi Arabia experience in pharmacovigilance.

Dr. Gahzi S. Saeed

Executive Director of Vigilance and Crisis

Management Department

11:40 – 12:10 Morocco's experience in pharmacovigilance.

Dr. Abdelhakim Zalim

Docteur en pharmacie

Pharmacien Inspecteur Chef de Division de la pharmacie

Kingdome of Morocco

12:10 – 12:30 The Egyptian Ministry of Health and Population

experience in pharmacovigilance.

Dr. Hadir Mamdouh Rostom Rapporteur of Pharmacovigilance Committee & Team Leader of The Egyptian Pharmacovigilance

center (EPVC)- Central Administration of Pharmaceutical Affairs-Egypt

12:30 – 12:50 The Saudi Food and Drug Authority experience in

drug awareness.

Ph. Abdulrhman S. Al Sultan

Executive Director of consumer Awareness

– Drug sector- SFDA

12:50 –1:10 The Egyptian Ministry of Health and Population

experience in drug awareness.

Dr Mahmoud Elmahdaway Hospital Pharmacy Manager, Central

Administration for Pharmaceutical Affairs (CAPA)

Ministry of Health

1:10 – 1:30 Discussion

1:30- 2:30 Praying & Lunch

Chairman: Prof. Saleh Bawazeer

2:30-4:30 Closing session & Recommendations

End of Day Three