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accreditation statistics

2018 Third Quarter Accreditations

Cellular Therapy Entities

  • Accredited: 231
  • Applicants: 6

Cord Blood Banks

  • Accredited: 54
  • Applicants: 9

During the third quarter of 2018, 20 entities received FACT accreditation. For details regarding these accreditations, view the full accreditation report.

A complete list of accredited organizations can be found at www.factwebsite.org.

Gratitude Expressed to Outgoing FACT Board Members

Posted in :: 2018 Volume 2 :: Tuesday, May 22nd, 2018

FACT is well-served by an involved, conscientious, and inspiring Board of Directors, and two outgoing Board members embodied all of those characteristics. While overcoming the snowstorms that seemed to follow the BMT community, FACT expressed its appreciation to Hugo Fernandez, MD and Gillian Woollett, MA, DPhil during the Board of Directors meeting at the 2018 BMT Tandem Meetings in Salt Lake City.

We look forward to continuing our relationship with these two outstanding individuals, who will no doubt continue to make a difference. Dr. Hernandez and Dr. Woollett, thank you for your service!

Hugo Fernandez, MD

• FACT, Board Member 2009 – 2017
• FACT, Secretary 2010 – 2016
• Chair, FACT Global Affairs Committee 2010 – 2018
• Member, FACT Technology Committee 2013 – 2018
• FACT Inspector for 20 years performing 30 clinical inspections

Dr. Fernandez’ charge as Chair of the Global Affairs Committee was to provide education, assistance, and a pathway for centers establishing new BMT programs in resource-challenged areas to achieve accreditation. Since 2010, Dr. Fernandez has worked with the committee to identify opportunities to educate the global cell therapy community about the importance of FACT accreditation in establishing quality systems as the foundation for transplant programs.

Dr. Fernandez organized educational outreach sessions in countries including:

• Africa
• Argentina
• Brazil
• Chile
• India
• Japan
• Mexico
• Peru
• Taiwan
• Vietnam

Thanks to the leadership provided by Dr. Fernandez, FACT now has accredited cell therapy programs located in seven countries (Australia, Brazil, Canada, Mexico, New Zealand, Singapore, and the United States) and counting!

Gillian Woollett, PhD

• FACT, Board Member 2009 – 2017
• FACT Public Director
• FACT Audit Committee 2009 – 2017
• Member, FACT Professional Relations Committee 2009 – 2017
• FACT Representative – ISCT Cell Therapy Liaison Committee (CTLM)

Dr. Woollett leads the FDA Policy and Regulatory Strategy Practice as a Senior Vice President at Avalere and supports clients throughout the healthcare system, from patients’ groups to biopharma companies and payers/providers.

Dr. Woollett has provided a wealth of knowledge and insight to FACT regarding:

• Scientific and regulatory policy expertise regarding medicinal products gaining FDA approval.
USP’s Compendial Notices informing stakeholders of the changing status of USP monographs and other USP standards-setting initiatives (Dr. Woollett serves on USP’s • Nomenclature and Labeling Expert Committee),
• FDA Guidance Documents and Final Rules,
• FDA Law and Proposed Legislation, and
• FDA Center for Biologics Evaluation and Research (CBER) Guidance.