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This Seminar will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. It will also provide few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. Learn the fundamentals of stem cells and FDA’s regulatory approach for its use in medicine.

Stem cells harness the power to differentiate into numerous cells upon stimulation. This has led to their wide exploration across all of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications. Attend this seminar to learn and apply the definitive ways to needed for the field to progress.

Learning Objectives:

Upon completing this course participants should have an understanding of:

  • Fundamentals of stem cells
    • How to control stem cell differentiation
    • Sources of stem cells
    • Incorporating stem cells into biomaterials
    • Avoiding immune system clearance of stem cells
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
  • FDA regulatory approach for the use of stem cells in medicine
    • Currently approved/accepted uses of stem cells in medicine
    • FDA guidance documents for stem cell technologies
    • Global approval of stem cell technologies (emphasis on EMA, Japan, China, India and Canada)
    • How the FDA regulates regenerative treatments and therapies
    • The use of human cells, tissues, and cellular and tissue-based (HCT/P) products and FDA’s regulatory framework
    • Use of non-HCT/P therapeutic materials (e.g., PRP and BMC) in the US
    • The drug and biological approval process
    • Regenerative products as medical devices
    • How to design appropriate clinical trials with an emphasis on stem cell-based materials
    • Applicable good manufacturing and good laboratory practices
    • Product labeling, marketing and advertising
    • FDA and other federal agency enforcement action
  • Future thoughts on approaches for regulatory approval of stem cell technologies
    • Remaining hurdles
    • Outlook for new technologies

Who will Benefit:

This course is designed for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Labelers and private labelers
  • Contract manufacturers
  • Importers and custom agents
  • U.S. agents of foreign corporations
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Legal professionals
  • Financial advisors and institutional investors
  • Patent lawyers
  • Graduate students
  • Academic faculty and professors
  • Clinicians
  • Entrepreneurs
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • Fundamentals of stem cells
    • Definitions
    • What is all the excitement about
    • How to control stem cell differentiation
    • Sources of stem cells
    • Incorporating stem cells into biomaterials
    • Avoiding immune system clearance of stem cells
    • Research examples pre-clinical approval
    • Research examples post-clinical approval
  • FDA regulatory approvals for the use of stem cells in medicine
    • Currently approved use of stem cells in medicine
    • FDA guidance documents for stem cell technologies
    • Global approval of stem cell technologies
Day 02(8:30 AM - 4:30 PM)
  • FDA regulatory approvals for the use of stem cells in medicine (continued)
    • How the FDA regulates regenerative treatments and therapies
    • The use of human cells, tissues, and cellular and tissue-based product criteria and “Minimal Manipulation Standard”
    • The drug and biological approval process
    • Regenerative products as medical devices
    • How to design appropriate clinical trials
    • Applicable good manufacturing and good laboratory practices
    • Product labeling, marketing and advertising
    • FDA and other federal agency enforcement action
  • Future thoughts on approaches for regulatory approval of stem cell technologies
    • Remaining hurdles
    • Outlook for new technologies
    • Strategies for commercializing stem cell technologies
  • Questions
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Theodore Sand

Theodore Sand,
Vice President, Greyledge Technologies LLC

Theodore T. Sand, Ph.D. (Vice President Research & Regulatory Affairs) joined Greyledge Technologies, LLC in September 2016. He is responsible for expanding the network of in-clinic processing laboratories operated by Greyledge. Dr. Sand also handles implementation of Greyledge’s Quality Management System, manages its clinical studies and the company’s research program. He previously was VP of Cellular Therapies & Regulatory Affairs at Celling Biosciences (Austin, Texas). Dr. Sand started working in translational cell therapy and regenerative medicine in 2002 when he created, optimized and validated the autologous fat tissue-derived stem cell therapy service offered by Vet-Stem, Inc. (Poway, CA).

Dr. Sand received both his B.S. (Microbiology, 1975) and Ph.D. (Biochemistry, 1982) degrees from the University of Minnesota (Minneapolis, MN) and was a Postdoctoral Fellow in the Department of Immunology at Scripps Clinic and Research Foundation (La Jolla, CA) from 1982 to 1983.

Dr. Sand has been the inventor or co-inventor on 15 patents, has coauthored 14 scientific publications and writes posts covering scientific, clinical and regulatory aspects of translational cell therapy for a blog on the Greyledge Technologies website. Two book chapters on the regulatory aspects of the point-of-care regenerative medicine field are pending publication.

Randall Thoma

Randall Thoma,
Principal, VeeSquared Consulting Services

Randy is currently the Principal at VeeSquared (V2) Consulting Services. "VeeSquared" is Verification and Validation. His consulting practice includes development and remediation of Quality Systems (medical device, over-the-counter drug, and blood processing) and process (especially cleaning validation) and test method qualification and validation and education.

He has also been an inspector for the American Association of Tissue Banks (AATB) since 2016.

Prior to entering consulting, he was the Associate Director of Quality Assurance for Zimmer Biologics. In this role he was responsible for Quality at the product development facility and for teaching the scientists how do develop and commercialize products, including human tissue products, targeting orthopedic early intervention.

He served on the AATB Accreditation Committee and is a past-Chair of the committee.

He is also the author and technical contact for the ASTM "Guide for Validating Cleaning Processes used during the Manufacture of Medical Devices".

He is a past President and CEO for a bereavement camp for children and is currently a volunteer driver for the local blood center.

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Register Now

Online using Credit card

$1,699.00

Seminar One Registration

October 7-8, 2019, Newark, NJ

$9,799.00

RECORDED VERSION (Unlimited viewing for 6 Months, Max. 10 Attendees)

Last Recorded on July 18-19, 2019

$9,999.00

One CD/USB (For usage in one location only)

Last Recorded on July 18-19, 2019




Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

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After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location:

    Newark, NJ
    (Venue to be announced shortly)

    October 7-8, 2019

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    Testimonials

    See What People Say About Us

    Presenters were encased & open to discussions.

    Compliance Director,

    Regenerative Medicine Solutions

    It was very helpful high level view of historical changes and the new provisions created to support new science.

    Manager,

    Bluebird Bio

    I really enjoyed this conference as I am new to the regenerative medical space & found this was a great source to get up to speed on how FDA is currently reviewing this space.

    Associate Product Manager,

    Zimmer Biomet

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    For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

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    Local Attractions of Newark, NJ

    Newark Museum:

    Newark Museum:

    The Newark Museum, in Newark, Essex County, is the state's largest museum. It holds fine collections of American art, decorative arts, contemporary art, and art from Asia, Africa, the Americas, and the ancient world. Its extensive collections of American art include works by Hiram Powers, Thomas Cole, John Singer Sargent, Albert Bierstadt, Frederick Church, Childe Hassam, Mary Cassatt, Edward Hopper, Georgia O'Keeffe, Joseph Stella, Tony Smith and Frank Stella. The Newark Museum's Tibetan galleries are considered among the best in the world. The collection was purchased from Christian missionaries in the early twentieth century.

    Prudential Center

    Prudential Center:

    Prudential Center is a multi-purpose indoor arena in the central business district of Newark. Opened in 2007, it is the home of the National Hockey League's (NHL) New Jersey Devils and the NCAA's Seton Hall Pirates men's basketball team. The arena seats 16,592 patrons for hockey and 18,711 for basketball. Fans and sports writers have affectionately nicknamed the arena "The Rock" in reference to the Rock of Gibraltar, the corporate logo of Prudential Financial, a financial institution that owns the naming rights to the arena and is headquartered within walking distance. In December 2013, the arena ranked third nationally and ninth internationally for self-reported annual revenue. It is located two blocks from Newark Penn Station in downtown Newark, just west of Newark's Ironbound district, making it easily accessible via New Jersey Transit, PATH, Newark Light Rail, and Amtrak.

    Branch Brook Park

    Branch Brook Park:

    Branch Brook Park is a county park of Essex County, located in the North Ward of Newark, between the neighborhoods of Forest Hill and Roseville. A portion of the park is also located within the Township of Belleville. At 360 acres, Branch Brook Park is the largest public park in the city of Newark. The park is noted for the largest collection of cherry blossom trees in the United States, with over 4,300 in more than fourteen different varieties collectively called Cherryblossomland, as well as its spectacular Cherry Blossom Festival each April. The festival attracts approximately 10,000 visitors each April. During World War II, the park's grounds served a tent city for recruits, as well as a landing strip for airplanes of the United States Postal Service. To the park’s east is the Cathedral of the Sacred Heart Basilica, one of the largest cathedrals in the United States.

    Cathedral Basilica of the Sacred Heart

    Cathedral Basilica of the Sacred Heart, Newark, New Jersey:

    The Cathedral Basilica of the Sacred Heart, the fifth-largest cathedral in North America, is the seat of the Roman Catholic Archdiocese of Newark. It is located at 89 Ridge Street in the Lower Broadway neighborhood of Newark, New Jersey. Envisioned as a fitting monument to the faith, construction began in 1899 and was finished in 1954. The original design called for an English/Irish-gothic church, but plans were later modified in favor of a French-gothic style. The Cathedral Basilica holds concerts open to the public throughout the year and it has the largest pipe organ ever built by the Schantz Organ Co. which includes 154 ranks playable from two consoles.

    Newark Symphony Hall

    Newark Symphony Hall:

    Newark Symphony Hall at 1020 Broad Street in Newark, Essex County, New Jersey, was built in 1925 and added to the National Register of Historic Places in 1977. Originally built by the Shriners at a cost of more than $2 million as Salaam Temple and colloquially known as The Mosque, the four-story building has been Newark Symphony Hall since 1964. The interior features Greek and Egyptian motifs, marble columns, a crystal chandelier, gold-leaf fret work and two-columned side promenades. The neo-classical building was design by Frank Grad, a prominent Newark architect, whose work includes the Lefcourt Newark Building and many others downtown. The 3,500-seat main concert hall is named for Sarah Vaughan, a native Newarker, and is renowned for its acoustics.

    Military Park

    Military Park:

    Military Park is a 6-acre city park in downtown Newark. It is a nearly triangular park located between Park Place, Rector Street and Broad Street. From 1667, when the city was planned, until 1869 it was a training ground for soldiers. In 1869, it became the town commons. The New Jersey Historical Society, Military Park Building and the New Jersey Performing Arts Center are located across Park Place from the park. A $3.25 million renovation was announced in February 2012 and the park reopened in June 2014.

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