ComplianceOnline

In 1997, the FDA proposed a comprehensive regulatory program for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/Ps) outlining the registration and listing procedures for HCT/Ps. This program also differentiates between HCT/Ps that will be regulated via the traditional pathway and those that will undergo approval as new drugs, biologics or devices.

In this seminar, we'll discuss the historical context for the use of HCT/Ps in medicine as well as how the HCT/P market is evolving. You will be shown examples of the FDA-approved use of HCT/Ps and what is required for successful product development. This course will also provide an overview of the health authority regulating HCT/Ps, discuss the regulations that govern HCT/Ps, discuss potential product development strategies and provide an overview of product development in the United States.

Learning Objectives:

Upon completing this course, participants will better understand:

  • The FDA’s regulatory approval process for HCT/Ps
  • Keys to successful product development of HCT/Ps
  • Application of “Minimal Manipulation,” “Homologous Use” and “Chemical Action”
  • Currently approved use of HCT/Ps in medicine
  • The drug and biologic approval process
  • Nonclinical requirements to support product development
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
  • Challenges of product characterization and specifications with respect to HCT/Ps
  • Requirements for compliance with good tissue practice, good manufacturing practice and good laboratory practice
  • FDA enforcement actions
  • The global regenerative medicine market
  • The One Health Initiative and its impact
  • HCT/Ps and translational medicine
  • Future approaches for regulatory approval of HCT/Ps in regenerative medicine

Who will Benefit:

This course is designed for professionals in biotechnology, regenerative medicine, HCT/P, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

  • Graduate students
  • Academic faculty and professors
  • Clinicians
  • Entrepreneurs
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing professionals
  • Quality Control professionals
  • Contract manufacturers
  • Foreign corporations in the regenerative medicine field
  • Financial advisors and institutional investors
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
  • FDA regulatory oversight of HCT/Ps
    • Historical Perspective
    • Laws and Regulations
    • Definitions
    • Jurisdiction
      • Tissue Reference Group
      • Office of Combination Products
        • Request for Designation
  • FDA regulatory approval process
    • HCT/Ps as drugs/biologics
    • HCT/Ps as medical devices
  • Compliance
    • Good tissue practice
    • Good manufacturing practice
    • Quality system regulations
    • Good laboratory practice
    • FDA enforcement actions
    • Adverse event reporting
Day 02(8:30 AM - 4:30 PM)
  • FDA regulatory guidance regarding HCT/Ps
    • Minimal manipulation
    • Homologous use
    • Same surgical procedure
    • Adipose tissue
  • Overview of FDA Public Workshop on Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval
    • Product development
    • FDA viewpoint
    • Views from professional societies
    • Patient experiences
  • Overview of FDA Part 15 Hearing on Draft Guidance Relating to the Regulation of HCT/Ps
    • Industry perspective
    • Professional society perspective
    • Patient perspective
    • HCT/Ps and translation medicine
    • One Health Initiative
  • Approaches for regulatory approval of HCT/Ps in regenerative medicine
    • FDA expedited review programs
    • Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Debra Webster

Debra Webster,
Principal Scientist, Regulatory Affairs and Product Development, Cardinal Health Regulatory Sciences | Ex-FDA Professional (Reviewing Pharmacologist)

Debra Webster, PhD, is Principal Scientist, Regulatory Affairs and Product Development, for Cardinal Health Regulatory Sciences. She began her regulatory career at the FDA and has more than 25 years of experience in drug development, focusing on nonclinical toxicology and proof-of-concept. Dr. Webster is responsible for nonclinical and regulatory consulting to guide products from pre-Investigational New Drug (pre-IND) application interactions with the FDA to New Drug Application (NDA) and Biological License Application (BLA) approval.

Prior to joining Cardinal Health, Dr. Webster was a medical writer at Quintiles, where she authored clinical study reports and nonclinical sections of INDs. Previously, she was in private practice, where she authored summaries of nonclinical data to support due diligence and regulatory submissions. Dr. Webster worked for the FDA in the Center for Food Safety and Nutrition, where she evaluated color and food additive petitions. Subsequently, she was a pharmacology/toxicology reviewer in the FDA Division of Antiviral Drugs in the Center for Drug Evaluation and Research, where she received the Commissioner Frank E Young Appreciation recognition for her role in the approval of Foscarnet.

Dr. Webster received a doctorate degree in pharmacology and toxicology at Virginia Commonwealth University, Medical College of Virginia. She received a bachelor’s degree in biology from Virginia Polytechnic and State University, where she graduated with honors and worked as a research associate in the anaerobic microbiology laboratory.

David A. Cummings

David A. Cummings,
RAC, Director, Scientific and Regulatory Consulting

David A. Cummings is Director, Chemistry, Manufacturing and Controls (CMC), for Cardinal Health Regulatory Sciences. He is responsible for scientific and regulatory consulting activities associated with pharmaceutical and biological product development, regulatory affairs strategy development, participation in FDA meetings, preparation of investigational and marketing applications for small molecules and biologics, good manufacturing practice qualification audits and good laboratory practice audits.

Cummings has more than 24 years of experience with development and regulatory affairs of small molecule and biologic products. His biologic experience includes viral antigens, enzymes, monoclonal antibodies, gene therapy products and therapeutic proteins. Prior to joining Cardinal Health in 2008, Cummings worked in several product development and regulatory affairs roles with Chiron Corporation, Gen-Probe, Collateral Therapeutics and Peregrine Pharmaceuticals.

Cummings received a bachelor’s degree in molecular, cellular and developmental biology from the University of Colorado and worked in the laboratory of Dr. Richard G. Ham. Cummings received regulatory affairs certification (RAC) in 2001.

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Online using Credit card

$1,699.00

March 2-3, 2017, Boston, MA
(For Registrations till December 20, 2016 - $1699)
(For Registrations till January 20, 2017 - $1799)
(For Registrations till February 5, 2017 - $1899)
(For Registrations after February 5, 2017 - $1999)

$2,299.00

Seminar One Registration (With 2 Nights Stay)

March 2-3, 2017, Boston, MA

$7,799.00
$10,194.00 (23%)*

Save $2,395.00

Special Group Discount Register for six attendees

March 2-3, 2017, Boston, MA
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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 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us 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.

Online using Credit card

$1,699.00

Seminar One Registration

July 13-14, 2017, Irvine, CA
(For Registrations till December 20, 2016 - $1699)
(For Registrations till January 20, 2017 - $1799)
(For Registrations till February 5, 2017 - $1899)
(For Registrations after February 5, 2017 - $1999)




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 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us 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.

Online using Credit card

$1,699.00

Seminar One Registration

October 19-20, 2017, Newark, NJ
(For Registrations till December 20, 2016 - $1699)
(For Registrations till January 20, 2017 - $1799)
(For Registrations till February 5, 2017 - $1899)
(For Registrations after February 5, 2017 - $1999)




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 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us 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 1:

Boston, MA
(Venue to be announced shortly)

March 2-3, 2017

Location 2:

Irvine, CA
(Venue to be announced shortly)

July 13-14, 2017

Location 3:

Newark, NJ
(Venue to be announced shortly)

October 19-20, 2017

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Media Partners
Platinum Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Gold Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert

If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

Sponsors
Platinum Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
Gold Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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

Local Attractions of Boston, MA

Boston Public Garden

Boston Public Garden

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

Boston Public Library

Boston Public Library

The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).

Fenway Park

Fenway Park

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

Museum of Fine Arts

Museum of Fine Arts

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

Museum of Science

Museum of Science

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

Local Attractions of Irvine, CA

The Irvine Museum

The Irvine Museum

The Irvine Museum collects and preserves California Art, with an emphasis on landscapes and Impressionist work. The Museum itself is a lovely hacienda style building, reminiscent of the Golden Land's early days.

Tanaka Farms

Tanaka Farms

Located in the heart of sunny Irvine, Tanaka farms provides fun, educational activities for kids and families. Seasonal tours of the Pumpkin Patch and Strawberry Fields, plus elaborate cook-outs and entertainment are among the delights offered at Tanaka farms.

Pretend City Children's Museum

Pretend City Children's Museum

Pretend City Children's Museum is a very promising place to bring children.

Orange County Great Park

Orange County Great Park

The Orange County Great Park is a vital center that brings together some of the southern California's exciting, diverse communities with educational workshops, farmer's markets, concerts and exhibits. The Park is currently expanding and will soon have an elaborate sports field as well.

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One of the largest and most popular Orange County attractions is just a short trip away. See Mickey, Minnie, Peter Pan, Winnie the Pooh, Alice in Wonderland and many of the world's most beloved characters and rides during a visit to the Magic Kingdom.

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