ISCT 2014 Pre-Conference Workshop PARIS, FRANCE

Transcription

1 Global Regulatory Perspectives ISCT 2014 Pre-Conference Workshop PARIS, FRANCE Shanta Sharma. Ph.D. & Abdelghani Tbakhi, MD, FCAP, Amman, Jordan

2 FROM BLACK IRIS TO GLOBAL REGULATORY COMPLIANCE

3 Jordan's National Flower BLACK IRIS is AN ENDANGERED SPECIES Described as: A flower of immense beauty and elegance, that will not live in housegardens. It has evolved in a windblown harsh environment and has acquired a unique color matching the black eyes of remote shepherds

4 At Nursing Day Celebration In the year 2009 I first learned about BLACK IRIS OF JORDAN Black Iris was chosen due to its spirit of determination, adaptability and survival that resembles the country of Jordan and its people.

5 The Story of Black Iris is also the story of In 1997, through dime and dinar donations of the citizens of Jordan, a humble community hospital was born. It was named Al-Amal Hospital. Al-AMAL MEANS HOPE

6 Birth of After King Hussein s passing away in 1999, Royal Family decided to build a cancer center in memory of their beloved King, so that cancer treatment is available, right at home. THUS A NOBLE DREAM BECAME A REALITY When in 2002, Al-Amal Hospital was restructured to become (KHCC).

7 Today Total Number of Staff is Around 1,900 Physicians 243 Full Time Consultants: 91 Specialists : 46 In Training Fellows: 27 Residents: 79 Nurses 607 RN s: 511 LPN s: 96 Pharmacists 75 Pharmacists : Assistant Pharmacists Clinical Pharmacists: 13 Other Staff

8 Growth of Services..limited only by space KHCC Parameter No. of OP visits 65,117 82,835 97, , , ,449 No. of Admissions Average length of stay Average length of stay (without BMT) Patient Satisfaction (Inpatient) Patient Satisfaction (outpatient) % 89% 86% 91% 89% 87% 87% 89% 86% 90% 92% 89%

9 Entering Global Healthcare Given its growth and to enter global healthcare, in 2011, KHCC decided to double its capacity by building: 14 story twin towers Global economical recession delayed the construction, however, the process has resumed and the structure will finish by the end of year 2015 and become functional in 2016.

10 Completed Facility will look like

11 KHCC Takes Pride in its Quality It has met many international accreditations JCI clinical care program CAP

12 Jordanian Regulations Healthcare regulations require joint approval of Jordanian King and the Parliament. Ministry of Health (MOH) enforces regulatory compliance through Jordanian FDA (JFDA). For the traffic of healthcare items, Jordanian security is also involved. For collaborative work outside, regulatory guidelines of participating countries are also followed

13 Jordanian Regulations are Still Evolving 2001: The first draft of Healthcare regulations was published. It was revised. The regulations are available through Jordan Ministry of Health (MOH) Jordanian citizens are informed about applicable regulations by publishing them in the local newspapers for 30 days

14 AREAS REGULATED BY Jordan-FDA 1. Direct Patient Care 2. Clinical Research Trials 3. Food, Drugs and Pharmaceuticals The regulations apply to private or public hospitals, academic institutions, research centers, laboratories, pharmaceutical companies and commercial facilities who offer above services

15 Jordanian Regulatory Documents Contain 1. Applicable rules and regulations 2. Qualifications of the institutions and staff 3. Ethical Issues 4. Penalty for deviations

16 Jordan also conducts Clinical Research Trials Jordan FDA ( a part of MOH), oversees clinical trials. Participating institutions have to have IRB and have to meet protocol guidelines. Regulatory compliance also applies to: Testing laboratories All collaborators ICH guidelines and global human ethical standards have to be met All subjects are medically insured

17 KHCC Patients enrollment in Clinical Trials is Growing Year # of Patients

18 Cell Therapy and Applied Genomics The plans are ambitious. One entire floor will be dedicated to cell therapy and applied genomics, including basic and translational research. Floor plans are shown in the next slide

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20 The regulations for Cell Therapy products 1. Basic guidelines were recently published, are in Arabic and still in the process of development. 2. For unrelated cellular products, we follow international guidelines, from procurement to storage, transplant and its outcome. The data are submitted to international registries.

21 Currently The facility will be launched under qualified GMP consultant Jordan has highly qualified and ambitious professionals, locally and overseas. The new task will be to enter global market, and focus on connectivity and global regulatory compliance

22 Picture Perfect Regulatory System With a recent trend of picture perfect regulatory system, innovative experiments are being conducted in different parts of the world, intended to maximize regulatory compliance, while minimizing the cost.

23 Is this yet another opportunity for the leaders in cell therapy? ISCT has always been an innovative, inclusive and futuristic organization. From time to time, it has streamlined information and charted the course. Prime examples are: ISHAGE Protocol for CD34+ enumeration Defining Mesenchymal Stromal Cells Why not now REGULATORY GUIDELINES THAT WILL SIMPLIFY THE BUDEN FOR ALL WITHOUT COMPROMIZING THE QUALITY?

24 Thanks For Your Attention