ComplianceOnline

Course "FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies" has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.

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.

This tutorial 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 the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in industry on how such therapies should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

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

Learning Objectives:

Upon completing this course participants should have an understanding of:

  • Fundamentals of stem cells
    • 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
  • 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
    • 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

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)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • 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
Gwen Wise-Blackman

Gwen Wise-Blackman
Principal Consultant, Gwen Wise-Blackman Consulting, LLC

Gwen Wise-Blackman, Ph.D., has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals. She is currently Principal Consultant at Gwen Wise-Blackman Consulting. Her career focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,499.00

Seminar One Registration

February 1-2, 2018, San Francisco, CA
(For Registrations till December 12, 2017 - $1499)
(For Registrations till January 14, 2018 - $1799)
(For Registrations after January 14, 2018 - $1899)

$2,299.00

Seminar One Registration (With 2 Nights Stay)

February 1-2, 2018, San Francisco, CA

$6,799.00
$8,994.00 (24%)*

Save $2,195.00

Special Group Discount Register for six attendees

February 1-2, 2018, San Francisco, CA
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




Early bird seats are limited and based on first-come, first-serve.

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


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

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
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.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
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.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location:

San Francisco, CA
(Venue to be announced shortly)

February 1-2, 2018

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

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

Media Partner:

Media Partner

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Local Attractions of San Francisco, CA

Think Escape Party Bus

Think Escape Party Bus
San Francisco Bay Area

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.

Alcatraz Lunch Cruise

Alcatraz Lunch Cruise

The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

Luxury Catamaran Sailing Cruise

Luxury Catamaran Sailing Cruise

A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.

City Kayak

City Kayak

City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

Think Escape Casino

Think Escape Casino Tour
San Francisco Bay Area

San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We need below information to serve you better

Best Sellers
You Recently Viewed
    Loading