MONROVIA, CA, March 20, 2013 (Press-News.org) Tiina Palomaki, Senior Researcher at The European Medicines Agency will present on "Regulatory Requirements for Stem Cell-based Medicinal Products in the EU" at GTC's Stem Cell Summit 2013 (Apr 29-30, 2013 in Boston, MA).
Stem cells hold the promise as a source of cells for therapeutic applications in various conditions, including metabolic, degenerative and inflammatory diseases, for the repair and regeneration of damaged or lost tissues and also in the treatment of cancer. The two principal characteristics that define stem cells, i.e. capacity to self-renew and differentiate make stem cells attractive and promising source for cellular replacement therapies. However, the same characteristics can be seen as the primary cause of additional risks of tumourigenicity as well as of unintended differentiation at ectopic locations. Safe therapeutic application of stem cells necessitates understanding the possible risks. Stem cells represent a spectrum of different cell-based products with varying amount of scientific data and clinical experience. Similarly, perceived risks associated with different types of stem cells are not the same.
In the EU, the regulatory framework for development of stem cell-based medicinal products is laid down in the legislation and in the guidelines. Existing EU guidance on cell based medicinal products lays down general outlines that are applicable to all cell based-medicinal products including stem cells. In addition, stem cell-associated additional safety concerns are covered in the recent Reflection paper on stem cell based medicinal products which highlights the potential and theoretical safety concerns based on the current scientific understanding, as well as the technical and methodological challenges related to non-clinical and clinical development of stem cell based products.
Dr. Tiina Palomäki has been working as a senior researcher at the Finnish medicines agency as a responsible person for preclinical aspects of advanced therapy medicinal products and biotechnological products since 2006. She was a member of the former European Medicines Agency (EMA) Cell-based product working party (CPWP) 2008-2012 and an alternate member of the former Gene therapy working party (GTWP) 2008-2010. Currently she is an expert of the Safety working party (SWP). She has been actively involved in development of the EU guidelines for cell-based medicinal products as well as for other biotechnological products.
Stem Cell Summit 2013 includes two parallel tracks. This summit provides cutting-edge information on developments in all areas of stem cell research including the biology, medicine, applications, regulations, and commercialization of stem cells.
Track A: Stem Cell Research & Regenerative Medicine:
Joint Session: Funding Opportunities
Joint Session: Regulatory Guidance & Updates
Session: Advances in iPS & ES Cells
Session: Advances in Adult Stem Cells
Session: New Paradigms for Cell Therapy
Track B: Stem Cell Commercialization & Partnering:
Joint Session: Funding Opportunities
Joint Session: Regulatory Guidance & Update
Session: Novel Technologies in Stem Cell Research
Session: Overcoming Challenges in Clinical Development
Session: Commercialization: Bringing Therapeutics to Market
Session: Partnerships & Acquisitions
Summit Agenda: http://www.gtcbio.com/stemcellsummit/agenda
Summit Speaker List: http://www.gtcbio.com/stemcellsummit/speakers
For more information, please visit http://www.gtcbio.com
ABOUT GTCbio
GTCbio organizes conferences specifically for the biomedical and biopharmaceutical industries. Our goal is to facilitate the exchange of biopharmaceutical and biomedical intelligence between industry leaders, academic and government organizations, and the financial community.
GTCbio is a subsidiary of Global Technology Community, LLC, a privately held company founded in 2002.
Contact: GTCBIO (626) 256-6405, (626) 256-6460 fax, infogtcbio@gtcbio.com
Tiina Palomaki of EMA to Present at Stem Cell Summit 2013 (April 29-30, 2013 in Boston)
Tiina Palomaki, Senior Researcher at The European Medicines Agency will present on "Regulatory Requirements for Stem Cell-based Medicinal Products in the EU" at GTC's Stem Cell Summit 2013 (Apr 29-30, 2013 in Boston, MA).
2013-03-20
ELSE PRESS RELEASES FROM THIS DATE:
Liberty Tax of North Park to Hold Free Tax Seminar
2013-03-20
Liberty Tax of San Diego is hosting a free tax seminar open to the public.
Free Education Programs & More
Let us share our knowledge with you - it's free! The certified tax preparers and consultants at Liberty Tax will focus their March 21st seminar on small businesses, discussing in detail the fundamentals of running a productive and successful business.
Topics of discussion include Schedule C, Depreciation, Business Use of the Home, and Record Keeping as well as many other areas of business tax preparation.
"We're happy to take care of everything for ...
Local Author's "Bound Trilogy" Now Featured at City Lights Bookstore, Sylva, N.C.
2013-03-20
The amazing adult fantasy series called the "Bound Trilogy" by local author I.R. Harris has arrived at City Lights Bookstore.
"I'm so honored and in awe of City Lights Bookstore for putting us front and center with so many wonderful authors," Harris said. "Thanks to all my readers for making this possible!"
Harris of Sylva, N.C., has found success with her trilogy and sold out of all copies at the Baltimore Book Festival in Baltimore, Maryland in September 2012.
The books of "The Bound Trilogy" are called "Bound," ...
IT Brand Pulse Honoring 2013 Networking Innovation Leaders at Ethernet Technology Summit
2013-03-20
The list of companies that stand out in the minds of IT professionals for network-related innovation in 2013 includes:
• Cisco captured six innovation awards in Ethernet Switches, Network Operating System, Low-Latency Ethernet Switches, Firewalls, Fibre Channel Network Monitoring and WLAN Controllers.
• VMware, the server virtualization pioneer, was selected as innovation leader for Network Virtualization and Software Defined Networking (Google and Cisco tied for second in the SDN category).
• Amazon Web Services was chosen as the innovation leader for Cloud Storage ...
Meals On Wheels West to delivery meals on two wheels on March 21 as part of national March for Meals Campaign
2013-03-20
Meals on Wheels West, supported by C.I.C.L.E., SM SPOKE and Sustainable Streets will cruise the bicycle friendly streets of Santa Monica to deliver food and friendship by bicycle to homebound neighbors on Thursday March 21.
Hitch your trailer,
grab your helmet and
hop on your bicycle
to deliver meals on two wheels
to homebound residents of Santa Monica.
On Thursday March 21th bicycle enthusiasts will gather at 10:00 am the offices of Meals On Wheels West, 1823 Michigan Ave., Santa Monica 90404. Teams will be dispatched on client routes with hot and cold ...
Generator Dan to Address the Bergen County Electrical Contractors Association About Meeting the Demand For Power
2013-03-20
Dan O'Brien, President of Academy Electrical, Inc., a full service electrical contractor specializing in emergency power generator installation, will address the monthly meeting of the Bergen County Electrical Contractors Association. The meeting will be held March 20, 2013 at the VFW Hall, 321 S. Washington Ave., in Bergenfield, NJ at 6PM.
With the frequency and severity of extreme weather events increasing in the northeast, Mr. O'Brien, aka Generator Dan, was asked by The Bergen County Electrical Contractors Association to speak at their monthly meeting because he ...
Andromeda POS Lets Pizza Restaurants Get Sales from Social Web Pages
2013-03-20
Pizza restaurants can have hundreds or thousands of fans on their social media platforms like Facebook and Twitter - what if they could turn those social pages building brand into pages that can directly boost sales? Now they can.
Leading point-of-sale solution provider Andromeda POS' newest capabilities help restaurant owners convert their websites and social platforms from brand-builders into buying pages. Customers can now order online, through their smartphones or even through the Facebook social network.
"We made online and mobile marketing and social engagement ...
Symon Garfield to Present on the Art of SharePoint Success at the Best Practices Conference
2013-03-20
Mindsharp, a SharePoint Training company, will be hosting the 2013 Best Practices Conference. This SharePoint Conference is unique because the focus will be on using SharePoint from the business side of the organization; there will not be an IT Pro or Developer track with technical information. There will be over 30 speakers from well-known profit and non-profit organizations, including Symon Garfield, Head of Business Consulting at Foundation SP. He specializes in supporting organizations develop and implement successful business strategies based on Microsoft productivity ...
Leading Travel Franchise Predicts Smooth Sailing Throughout 2013
2013-03-20
Expedia CruiseShipCenters Yields Growth in their 25th Year
Expedia CruiseShipCenters - part of Expedia Inc, the largest online travel company in the world, has announced its 2012 bookings at an 8 percent increase over the previous year.
"This growth is attributed to our Franchise Partners and their sales teams who are the key to our success. Through all of their hard work, in conjunction with our focused promotions strategy, they have been successfully building Customers For Life," says Matthew Eichhorst, President of Expedia CruiseShipCenters. "This ...
Students Against Violence Everywhere Sponsors National Youth Violence Prevention Week March 18-22
2013-03-20
Students Against Violence Everywhere (SAVE) (http://www.nationalsave.org), a national nonprofit organization dedicated to ending violence in schools and communities through promoting student involvement, education and service opportunities in efforts to provide safer environments for youth, has kicked off National Youth Violence Prevention Week. Taking place Monday, March 18 through Friday, March 22, National Youth Violence Prevention Week aims to raise awareness, and to educate students, teachers, school personnel, parents and the public on effective ways to prevent or ...
Gardere Arena Adds International Arbitration Attorney in Mexico City
2013-03-20
International arbitration attorney Viviana Castro-Hurtado has joined the Mexico City office of Gardere Arena y Asociados S.C. as a member of the Firm's Mexico and Latin America practice, where she will focus on representing clients involved in commercial and investment arbitrations.
Formerly of White & Case, Ms. Castro-Hurtado has handled dozens of arbitration matters under various international arbitration rules, including the American Arbitration Association/International Centre for Dispute Resolution, International Chamber of Commerce, International Centre for ...
LAST 30 PRESS RELEASES:
Launch of the most comprehensive, and up to date European Wetland Map
Lurie Children’s campaign urges parents to follow up right away if newborn screening results are abnormal
Does drinking alcohol really take away the blues? It's not what you think
Speed of risk perception is connected to how information is arranged
High-risk pregnancy specialists analyze AI system to detect heart defects on fetal ultrasound exams
‘Altar tent’ discovery puts Islamic art at the heart of medieval Christianity
Policy briefs present approach for understanding prison violence
Early adult mortality is higher than expected in US post-COVID
Recycling lithium-ion batteries cuts emissions and strengthens supply chain
Study offers new hope for relieving chronic pain in dialysis patients
How does the atmosphere affect ocean weather?
Robots get smarter to work in sewers
Speech Accessibility Project data leads to recognition improvements on Microsoft Azure
Tigers in the neighborhood: How India makes room for both tigers and people
Grove School’s Arthur Paul Pedersen publishes critical essay on scientific measurement literacy
Moffitt study finds key biomarker to predict KRASG12C inhibitor effectiveness in lung cancer
Improving blood transfusion monitoring in critical care patients: Insights from diffuse optics
Powerful legal and financial services enable kleptocracy, research shows
Carbon capture from constructed wetlands declines as they age
UCLA-led study establishes link between early side effects from prostate cancer radiation and long-term side effects
Life cycles of some insects adapt well to a changing climate. Others, not so much.
With generative AI, MIT chemists quickly calculate 3D genomic structures
The gut-brain connection in Alzheimer’s unveiled with X-rays
NIH-funded clinical trial will evaluate new dengue therapeutic
Sound is a primary issue in the lives of skateboarders, study shows
Watch what you eat: NFL game advertisements promote foods high in fat, sodium
Red Dress Collection Concert hosted by Sharon Stone kicks off American Heart Month
One of the largest studies on preterm birth finds a maternal biomarker test significantly reduces neonatal morbidities and improves neonatal outcomes
One of the largest studies of its kind finds early intervention with iron delivered intravenously during pregnancy is a safe and effective treatment for anemia
New Case Western Reserve University study identifies key protein’s role in psoriasis
[Press-News.org] Tiina Palomaki of EMA to Present at Stem Cell Summit 2013 (April 29-30, 2013 in Boston)Tiina Palomaki, Senior Researcher at The European Medicines Agency will present on "Regulatory Requirements for Stem Cell-based Medicinal Products in the EU" at GTC's Stem Cell Summit 2013 (Apr 29-30, 2013 in Boston, MA).