3rd Annual Cold Chain MENA

8:30 AM Registration and refreshments

8:50 AM Chairpersons opening remarks

André N. Verdier , President, Executive Committee Supply Chain and logistics Group, UAE

André N. Verdier
President
Executive Committee Supply Chain and logistics Group, UAE

9:00 AM Reviewing Jordanian GSDP guidelines for temperature sensitive pharmaceuticals

Lubna Qusous , Head of Quality Control Laboratory, Jordanian FDA

Identifying the role of Jordanian FDA in regulating the pharmaceutical industry in Jordan
Overview of the recent JFDA updates regarding the distribution of cold chain pharmaceuticals
Assuring patient safety through appropriate distribution and storage of temperature sensitive pharmaceuticals

Lubna Qusous
Head of Quality Control Laboratory
Jordanian FDA

9:40 AM Executive exchange

Meet, network and exchange business cards in Pharma IQ’s exclusive, lively networking session. In this revolutionary, quick-fire format, you can meet every single delegate and exchange best practice and strategies.

Don’t forget to bring along plenty of business cards.

10:00 AM Exclusive presentation from Cryoport

10:30 AM Networking tea break

11:00 AM On stage interview: The Ministry of Health’s efforts to ensure the safety and quality distribution of temperature sensitive medicines

Dr. Amin Al Amiri , Asst. Undersecretary , Medical Practices and Licenses, (CEO), Ministry Of Health

In this innovative format, Dr. Amin Al Amiri will be interviewed regarding the Ministry of Health’s efforts and strategies to ensure safety and quality distribution of temperature sensitive pharmaceuticals

Dr. Amin Al Amiri
Asst. Undersecretary , Medical Practices and Licenses, (CEO)
Ministry Of Health

Dr. Amin Hussain AI Amiri is the Asst. Undersecretary for Medical Practice and License Sector in UAE Ministry of Health, and the Chairman of the UAE
Supreme National Blood Transfusion Committee. Dr. AI Amiri got his Ph.D. and Ms. C. in Medical Science in 2003 from Faculty of Medicine; Aberdeen University in Scotland; UK.

He is re ...[Read More]

11:30 AM Case Study: Regional overview on Good Distribution Practice regulations to ensure the safety, quality and efficacy of your cold chain

Hany Gamal , Regional Manager of Drug Regulatory, Boehringer Ingelheim

Reviewing GDP regulations across the Middle East and overview of the written procedures to ensure incoming cold chain products are distributed and stored in compliance with regulations
Checking signs of non-compliance with cold chain storage to preserve product quality
Conducting a regular monitoring programme to monitor temperature during storage and transportation

Hany Gamal
Regional Manager of Drug Regulatory
Boehringer Ingelheim

Hany is currently the Regional Drug regulatory Affairs Manager heading the department for an innovative Multinational pharmaceutical company.

He has an extensive experience in the pharmaceutical field with over 18 years; 12 years of which in the sales and marketing side of business while 6 years within DRA, with a good exposure to all th ...[Read More]

12:10 PM Lunch break and networking opportunity

1:10 PM Case Study: Implementing quality management of cold chain in VACSERA– Egypt

Dr. Manal Elkashef , Director, Quality Operation, VACSERA

Understanding the International regulations for Vaccine cold chain management
Monitoring of temperature monitoring through the vaccine life cycle vaccine starting from the raw materials used in vaccine production up to the intermediate bulk and final product
Analysing vaccine stability during storage

Dr. Manal Elkashef
Director, Quality Operation
VACSERA

1:50 PM Conducting stability studies and interpreting stability data to minimise excursion

Hasan Jabarti , Head of Quality Assurance, Novartis Pharma Services

Identifying stability requirements for product registrations in the MENA region
Learning how to set up shipping temperature excursion studies
Creating, analysing and reporting stability data for cold chain products

Hasan Jabarti
Head of Quality Assurance
Novartis Pharma Services

2:30 PM Afternoon tea break

3:00 PM Overcoming the key challenges of managing the global clinical trials logistics

Sahar Ebrahim , Director, Clinical Operations, Quintiles

Dealing with the variable drug import regulations and the local logistics expertise
Satisfying the different labeling requirements and human biological specimen regulations
Understanding the significant impact that clinical logistic approach can have on cost and times of study conduct

Sahar Ebrahim
Director, Clinical Operations
Quintiles

Graduated from Alexandria Medical School complemented her medical background with a public health post-graduate degree from Cairo university.

Dr. Sahar Ebrahim Has more than 16 years of work experience in the pharma industry assuming different roles with last 12 years dedicated to clinical research during which had extensive experience f ...[Read More]

3:40 PM Managing the distribution of clinical trial materials to ensure the preservation of the quality during transportation

Wael Tarhini , Senior Clinical Research Associate, ClinArt

Reviewing new technologies in packaging, temperature monitoring and vendor qualification to ensure good quality distribution of clinical trials materials
Defining the system to be followed during distribution
Learning about potential solution applications of risk management including live examples from the MENA region

Wael Tarhini
Senior Clinical Research Associate
ClinArt

Wael Tarhini is a clinical Research professional with around 5 years of experience as a clinical research associate and project manager for diverse clinical trials, Certified from Association of Clinical Research Professionals (ACRP), he has a deep knowledge of operational issues and challenges within the evolution of clinical trials in the MENA ...[Read More]

Conference Day One: Tuesday 16 October 2012