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January 23 |
How to meet GMP's for phase 1 trials |
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February 6 |
Risk Evaluation Management |
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Febrary 27 |
Facility Size and Challenges in the Lab: More Volume, More Problems? |
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March 13 |
Business Models and Cost of Goods |
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March 27 |
How to always be inspection-ready |
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May 08 |
Validation Requirements for Computerized Systems |
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June 05 |
Preclinical PK/PD analysis of cell therapies vs. small molecules |
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June 17 |
ATMP Regulations |
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July 10 |
Practical Guide to INDs/IDEs |
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July 24 |
Highlights from 2013 Annual Meeting Quality and Operations Track |
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August 07 |
Clinical Trials Design End Points |
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September 25 |
TBD |
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October 09 |
Technological Advances in Contamination Testing |
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October 23 |
Reimbursement Topic |
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November 06 |
Preparing the Lab for a New Clinical Trial |
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November 20 |
Clinical biomarkers for cell therapies |
LPC - Lab Practices Committee
NA LRA - North America Legal & Regulatory Affairs Committee
CC - Commercialization Committee
Registration Rates
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Early Registration |
Late Registration |
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ISCT Members |
$90 |
$105 |
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Non-ISCT Members |
$105 |
$120 |
Registration includes:
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1 audio line and 1 web access to the live webinar
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access to PDF copies of the slides before the webinar
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access to the audio recording post-webinar upong completion of the webinar survey
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one credit hour for the registered participant upon completion of the webinar survey. Additional CMLE credits are available for $5 per participant/webinar
- Registration and Recording Fees are in USD
Non Canadian/US Participants
We now offer broadcast audio for ALL webinars! Please register and you will be forward instructions on how to tune in prior to the webinar.
Cancellation Policy:
We are unable to offer refunds for cancellations. However, we can exchange your webinar registration for a digital recording in the event you are no longer able to attend the live event.
Digital Recordings for Purchase
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Price |
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ISCT Members |
$70 |
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Non-ISCT Members |
$85 |
Digital Recordings are available if you cannot make the webinar. The Digital Recording includes:
- PDF slide presentations
- audio recording of the presentations
- Multimedia slide presentation with audio overlay
CMLE credit is not granted for Digital Recording purchases
ISCT MEMBERS: Please note that all ISCT members will receive access to the slides and audiorecording on the website 3 months post-event. The purchase of a Digital Recording would be advantageous in the event you require access to the slides and recording within this time frame.
How to meet GMP's for phase 1 trials
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Organized by the ISCT North America Legal and Regulatory Affairs Committee Chair and Speaker: Debe Griffin, MSc, Quality Assurance Manager for Cellular Therapies, University of Pittsburgh Cancer Institute, USA Speaker: Angela Pardee, Postdoctoral Associate, Dept. Medicine, University of Pittsburgh, presenting on behalf of Lisa H. Butterfield, Ph.D. Associate Professor of Medicine, Surgery and Immunology Director, UPCI Immunologic Monitoring and Cellular Products Laboratory University of Pittsburgh
Registration (Early Deadline: January 16th; Late Deadline: January 21st): Early registration for members: $90, non-members: $105 About the Webinar: Goals of the webinar (for the presenters):
Learning objectives (for the participants):
Register NowPurchase or Access the Recording (FREE for members 3 months post event) Back to top |
Risk Evaluation Management
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Organized by the ISCT Commercialization Committee February 06, 2013 Chair: Wouter Van't Hof, PhD, Senior Director of Regenerative Medicine, Athersys, Inc. USA Speakers: Natalie Mount, PhD, Chief Clinical Officer, Catapult Limited, UK and Karin Hoogendoorn, Janssen Biologics BV, The Netherlands Registration (Early Deadline January 30th, Late Deadline February 4th): Early registration for members: $90, non-members: $105 About the Webinar: Similar to the path for drugs, the development of cell therapy products (CTP) is a high risk and expensive endeavor. Regulatory expectations, development time and specific challenges for each development stage need to be taken into account. The Target Product Profile (TPP) concept provides an important mechanism for risk management and symbolizes the idea of beginning a development process with the ultimate product in mind. More specifically, as stated in regulatory guidance documents, “the TPP should represent the ideal version of what the sponsor would like to claim for product labeling, and the design, conduct, and analysis of clinical trials to maximize efficiency of program development”. Although commonly implemented for drugs, especially in big pharma, it appears the TPP concept has not yet been widely considered as a disciplined planning approach for CTP development. Purchase or Access the Recording (FREE for members 3 months post event)
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Organized by the ISCT Lab Practices Committee Chair: Deborah Lamontagne, B.S.,MLS (ASCP)CM, Cellular Therapy Manager, Florida Hospital Cellular Therapy Laboratory, USA Speakers: Karl Stasko, MPH, Stem Cell Transplant Lab Supervisor, Cell Manipulation Core Facility, Dana Farber Cancer Institute, USA and Heather Hansen, BSc, Cell Processing Technologist, Cell Manipulation Core Facility, Dana Farber Cancer Institute, USA Registration (Early Deadline February 20th, Late Deadline February 25th): Early registration for members: $90, non-members: $105 About the Webinar: The learning objectives for this webinar are:
Register NowPurchase or Access the Recording (FREE for members 3 months post event) Back to top
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Business Models and Cost of Goods
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Organized by the ISCT Commercialization Committee Speakers: TBD Registration (Early Deadline March 6th, Late Deadline March 11th): Early registration for members: $90, non-members: $105 About the Webinar: TBA Register NowPurchase or Access the Recording (FREE for members 3 months post event) Back to top |
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Organized by the ISCT North America Legal and Regulatory Affairs Committee Speakers: Olive Sturtevant and Ed Brindle, MSc, MT, Manager, Quality and Regulatory Affairs at Insception Biosciences, Ontario, Canada About the Webinar: Are you inspection ready for accrediting or regulatory agencies that might knock on your door? In this ever changing and heavy regulated field of cellular therapy, it is a challenge to keep current with the variety of agencies that inspect and accredit our manufacturing and testing labs. With more and more international clinical trials, many of our labs are subject to inspections from international agencies. Once you understand the focus of each agency assessing, you can better prepared for those encounters. Aside from looking at the basics, this webinar will take a more in-depth look at similarities and differences between US, Canadian and UK agencies. There are steps you can take to make the process less stressful, and to avoid the most common issues arising during these inspections Learning Objectives
Who should attend? Quality & Regulatory Staff responsible for compliance Laboratory staff Managers and Supervisors Why you should attend Cell Therapy programs and manufacturers are subject to numerous inspections from a variety of agencies with different areas of focus. This webinar will address common practices to prepare for both the announced and unannounced audits. We will also discuss some of the similarities and difference between US and International inspections and assessments that are common areas focused on for cell therapy manufacturers. Register NowPurchase or Access the Recording (FREE for members 3 months post event)
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Validation Requirements for Computerized Systems
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Organized by the ISCT Lab Practices Committee May 8th, 2013 Speaker: Andrew Havens, ECL2 Quality Solutions Registration (Early Deadline May 1st, Late Deadline May 6th): Early registration for members: $90, non-members: $105 About the Webinar: Computerized Systems are becoming more prominent in, and in some cases, an integral part of cellular therapy processes. Quality management Systems, Lab Information Management Systems and Inventory Software are just a few examples. According to 21 CFR 1271.160b.6.d regarding computers, the agency states we must validate the performance of computer software for the intended use when we rely on the system to comply with core cGTP requirements, whether custom designed or commercially available. However, the term "Validation" is open to a wide range of interpretation. How does a facility go about properly validating something as complex as a computerized system? Learning Objectives:
Register NowPurchase or Access the Recording (FREE for members 3 months post event)
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Preclinical PK/PD analysis of cell therapies vs. small molecules
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Organized by the ISCT Commercialization Committee June 5th, 2013 Speaker(s): TBD Registration (Early Deadline May 29th, Late Deadline June 3rd): Early registration for members: $90, non-members: $105 About the Webinar:
TBA Register NowPurchase or Access the Recording (FREE for members 3 months post event)
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ATMP Regulations |
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Organized by the ISCT EU Regional Leadership Committee and EU LRA June 17th, 2013
Speakers: Martin Hildebrandt, MD, Technische Universität München, German and Anne Dickinson, MD, Royal Victoria Infirmary, UK
Registration (Early Deadline June 10th, Late deadline June 13th): Early registration for members: $90, non-members: $105 About the Webinar: TBD Register NowPurchase or Access the Recording (FREE for members 3 months post event)
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Practical Guide to INDs/IDEs |
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Organized by the ISCT NA LRA July 10th, 2013 Chair: Bill Janssen, PhD, Director, Cell Therapies Facility, H. Lee Moffitt Cancer Center Speaker(s): TBD Registration (Early Deadline July 3rd, Late deadline July 8th): Early registration for members: $90, non-members: $105 About the Webinar: TBA Register NowPurchase or Access the Recording (FREE for members 3 months post event) Back to top |
Highlights from the 2013 Annual Meeting Quality and Operations Track
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Organized by the ISCT Lab Practices Committee July 24, 2013 Chair: Martin Hildebrandt, MD, Head GMP Facility, Technische Universität München Speaker(s): TBD
Registration (Early Deadline July 17th; Late Deadline July 22nd): Early registration for members: $90, non-members: $105 About the Webinar: TBD Register NowPurchase or Access the Recording (FREE for members 3 months post event) Back to top
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Clinical Trial Design End Points |
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Organized by the ISCT Commercialization Committee August 7th, 2013 Chair: Claudia Zylberberg, PhD, CEO, Akron Biotech Speaker(s): TBD Registration (Early Deadline July 31st, Late Deadline August 5th): Early registration for members: $90, non-members: $105 About the Webinar: TBD
Register NowPurchase or Access the Recording (FREE for members 3 months post event) Back to top |
TBD |
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Organized by the ISCT EU Legal and Regulatory Affairs Committee September 25th, 2013 Chair: TBD Speaker(s): TBD Registration (Early Deadline September 18th, Late Deadline September 23rd): Early registration for members: $90, non-members: $105 About the Webinar: TBD
Register NowPurchase or Access the Recording (FREE for members 3 months post event) Back to top |
Technological Advances in Contamination Testing |
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Organized by the ISCT NA Legal and Regulatory Affairs Committee October 9th, 2013 Chair: TBD Speaker(s): TBD Registration (Early Deadline October 2nd, Late Deadline October 7th): Early registration for members: $90, non-members: $105 About the Webinar: TBD
Register NowPurchase or Access the Recording (FREE for members 3 months post event) Back to top |
Reimbursement Topic |
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Organized by the ISCT Commercialization Committee October 23rd, 2013 Chair: Richard Maziarz, MD, Professor of Medicine, Oregon Health and Science University Speaker(s): TBD Registration (Early Deadline October 16th, Late Deadline October 21st): Early registration for members: $90, non-members: $105 About the Webinar: TBD
Register NowPurchase or Access the Recording (FREE for members 3 months post event) Back to top |
Preparing the Lab for a New Clinical Trial |
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Organized by the ISCT Lab Practices Committee November 6th, 2013 Chair: Joseph Mierski, MSc, Hematopoietic Cell Therapy Lab Coordinator, Speaker(s): TBD Registration (Early Deadline October 30th, Late Deadline November 4th): Early registration for members: $90, non-members: $105 About the Webinar: TBD
Register NowPurchase or Access the Recording (FREE for members 3 months post event) Back to top |
Clinical Biomarkers for Cell Therapies |
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Organized by the ISCT Commercialization Committee November 20th, 2013 Chair: Aleks Francki, PhD, Senior Principal Scientist, Celgene Cellular Therapeutics Speaker(s): TBD Registration (Early Deadline November 13th, Late Deadline November 18th): Early registration for members: $90, non-members: $105 About the Webinar: TBD
Register NowPurchase or Access the Recording (FREE for members 3 months post event) Back to top |
