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Since the FDA and EMA published their current thinking on clinical oversight and risk-based monitoring (RBM) strategies, the topic has received a magnitude of attention, commanding column inches, webinar discussions and industry conferences. With so much discussion going on, it is unsurprising that many sponsors are feeling out in the cold when it comes to identifying how to practically implement RBM strategies within study designs. As data quality matters most in determining study success and ensuring patient safety, the latest recommendations have created growing demand for solutions that simplify the transition to risk-based techniques.
In this program, our guests discuss how emerging technologies and Central Statistical Monitoring (CSM) now present more practical means of implementing successful RBM strategies. Both Sanofi and Novartis will provide a large pharma perspective on making the move to RBM.
Host: Valerie Bowling, Executive Director, The Conference Forum
Marc Buyse, Founder, International Drug Development Institute & CluePoints
Eric Genevois-Marlin, VP, Biostatistics & Programming, Sanofi
Thomas Haag, Data Integrity Process Expert, eClinical Quality Assurance, Novartis Pharmaceuticals
Wednesday, February 25, 2015
1:00-3:00PM Pacific (2-4pm Mountain; 3-5pm Central, 4-6pm Eastern)
Nano BioSensors: Nasal, Organ and Biological Systems Monitoring
In the 1966 film Fantastic Voyage, a group of scientists board a submarine and are shrunk down to a microscopic size in order to enter the bloodstream of a diplomat and save their life from a bloodclot. While this remains an idea of science fiction, we are forever moving closer to a time when fantastic ideas such as these come to fruition - though not in a way we expected.
This week on One Cell One Light Radio, Dr. Hildy will discuss the concept of using nanotechnology as bio-sensors, and the benefits and dangers of their use.
Imagine your body as a highly complex machine - the most complex ever created. Through natural processes, this machine runs itself. When your body temperature drops, you feel cold. If you lack iron, you may crave red meat or another source from which you are used to getting it. But these processes are automatic and uncontrollable. You can’t tell if you’re getting enough iron until you’re not.
Now imagine if you had a method of constantly monitoring your body’s processes - like the real-time fuel consumption in your vehicle. Using a fairly simple equation, your car knows the rate of fuel it’s burning and approximately when it will run out of gas. What if you knew that you that you were lacking iron before your body even did? This is just one possibility of the use of nano bio-sensors. MORE>> https://onecellonelightradio.wordpress.com/2015/02/25/dr-hildy-nano-biosensors/
Welcome to the TechSource podcast series. Today we are speaking with Paul Cruthfield, Director of Sales Engineering at Tenable Network Security, about continuous monitoring and federal agencies.
Last week, Chapman began Chapter 4 of MIRACLE ZONE by teaching Understanding the Power of Thoughts and Words. She continues, live from the Yucatan, on the topic of co-creating your world through thoughts and words with emphasis this week being on the importance of monitoring your energy. While most people can easily tell if their energy is low or high--most do not realize when their energy has been compromised or contaminated. Join her 9:00 AM Pacific ... 12 Noon Eastern.
Join us this evening as Rebecca Campbell and I discuss Remote Neural Monitoring and Surveillance.
Advanced surveillance technologies can also be used for harassment. Experimental technologies can include brain wave monitoring via satellite and analyzed through thought activated computers.
Voice-to-skull operations are underway with many believing they have been targeted with these technologies.
Other methods include eavesdropping, satellite lazer harassment, and visual monitoring.
Thermal imaging satellites, including aircraft-based "monitors" which may be loaded into the Drones the government is intending to use on the public.
Drones, wired for surveillance street lights, camera's on every corner, and mics and videos in the stores you shop.
Guidance on Environmental Monitoring and Control of Listeria for the Fresh Produce Industry with Elis Owens, Ph.D.
Elis is active in developing Birko’s antimicrobial product line and attendant delivery systems.
He oversees field trials at customer plants, works with university research partners and outside labs
and acts as a government liaison for antimicrobial approvals.
Elis earned his Ph.D. from the University of Wales in Cardiff.
He conducted post-doctoral research at Michigan State University’s Center for Microbial Ecology.
He has published papers in Federation of European Microbiological Societies (FEMS) Microbiology Ecology
and FEMS Microbiology Letters. Elis has been a presenter at the Produce Marketing Association,
the Beef Industry Food Safety Council (BIFSCo) and the North American Meat Association.
He is a member of the International Association for Food Protection (IAFP), Master Brewers Association of the Americas (MBAA),
American Oil Chemists’ Society (AOCS) and the American Society of Brewing Chemists (ASBC).
Guidance on Environmental Monitoring and Control of Listeria for the Fresh Produce Industry United Fresh Produce Association
2. What is listeria?
3. How can we minimize microbial food safety hazards of fresh cut fruits and vegetables?
4. What are some listeria control measures relevant to fresh produce?
5. How do you kill listeria and control its growth?
Elis Owens, Ph.D.
Director of Business Development and Food Safety for Produce
On tonites episode we will talk about the Terrorist organization ISIS who are monitoring many weak spots along the Border for a possible attack in the USA on the 13th Anniversary of 9/11.Keeper will be ny special guest starting at 6:30pm eastern time, and 3:30pm pacific at www.blogtalkradio.com/patriotnation
Ottawa, Ontario – Children who begin using substances while their brain is still rapidly developing can become addicted much faster than an adult, sometimes as quick as six months depending on the substance. According to the Canadian Alcohol and Drug Use Monitoring Survey, youths 15 to 24 years old have the highest self-reported use of illicit substances compared to other Canadians and are approximately five times more likely to report harm because of drug use.
A child struggling with addiction can’t be expected to navigate their way through these challenges by themselves. It’s a family process. Shontelle Prokipcak is a registered social worker who has been providing mental health and addiction services for children, youth, young adults and their families in the Ottawa Region for over 14 years. Shontelle has extensive training and experience in counseling, crisis management, trauma, victim assistance, addiction issues and treatment, as well as youth conduct disorders.
“I collaborate with schools and the family doctor and the families themselves, even grandparents, so everyone is working together,” says Shontelle. “I try to get everybody on board with my treatment plan because we have better outcomes from that kind of collaboration.”
Shontelle's expertise is working with children, youth and families who have challenges at home or in the community and struggle with anxiety and depression, behavioral problems and addiction.
“Kids don’t know how to regulate their emotions because they’ve been using substances to do that,” explains Shontelle. “We work on concrete skills for the kids to use to deal with stress.”
For more information on Shontelle Prokipcak, visit http://www.shontelle.ca/
The Institute for Inclusion in the Legal Profession (“Institute”) is a 501(c)3 not-for-profit organization that, through educational programs, research and publications, will address the lack of diversity and inclusion that continues to challenge the legal profession and undermine its credibility within the justice system.
Floyd Holloway is Counsel in the Corporate Law Department. His responsibilities include monitoring and advocacy in legislative and regulatory matters in New York State. Floyd manages the Corporate Law Department’s Legislative Services Unit, which, among other things, provides support to the Enterprise, including the network of state counsel responsible for legislative and regulatory affairs. Floyd is a past chairman of the New York Insurance Association (NYIA). He also sits on the Executive Board for the Lawsuit Reform Alliance of New York (LRANY). Floyd is an active member of the American Bar Association, serving as vice-chair on the Corporate Counsel, Government Law, Law in Public Service and Technology Committees.
A native of Brooklyn, New York, Floyd received his B.A. degree in political theory and American government from Georgetown University College of Arts and Sciences in Washington, D.C., and his law degree (J.D.) from the Georgetown University Law Center.
First Hour: Sentri, Wendy Qi, CEO and co-founder
Our guest this hour will be telling you all about Sentri, a complete home monitoring and automation solution in one beautiful display. Sentri adapts to your home and delivers personalized alerts along with a live HD video feed straight to your smartphone, no matter where you are.
Second Hour: Reltio, Manish Sood, CEO and founder.
Reltio was founded upon the belief that organizations need reliable, relevant access to information at their fingertips. We help companies turn their data into information and knowledge assets in the most efficient way, shattering the traditional notion that IT must combine multiple technologies to manage different types of data, and that business users must purchase standalone tools to do their own analysis.