Regulations in the US and EU Dealing with Combination Products

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Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and meaning of all the regulations. Such businesses need to understand the nuances of the regulatory expectations and do what it takes to meet these.

Professionals and organizations that work in these areas must familiarize themselves with the existing regulations and their latest updates. This is the foundation to ensuring that their products comply with regulatory requirements and meet quality standards, which ensures that the consumer consumes products that are of the set scientific standards.

The regulations in the two markets have evolved differently. The fact that the regulatory agencies in the two markets, namely the US FDA and the European Medicines Agency (EMA) work to ensure the quality of drugs and thus the wellbeing of their consumers is the commonality between the two.

While the US FDA is a centralized agency that regulates food and medicinal products across the vast US market; the EMA, synchronizes the regulations of the 28 countries that are members of the European Union. While the FDA was primarily created to be a consumer protection agency; the regulations from the EMA came about to harmonize the commercial and technological interests of the Member States.

The EU’s new update

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In September 2016, the EU, through its two major legislative organs -the European Commission and the European Council, reached a compromise on a major area concerning combination products. Reached four years after a deal was made; the compromise relates to medical devices and invitro diagnostic (IVD) devices.

High risk combination devices, such as implants, will from now be assessed and authorized by the EMA. Brought in to replace the existing EU legislation on medical devices and in-vitro diagnostics; the new regulation seeks to make these products more consistent and uniform in terms of their assessment and approval process across the EU.

Thorough and sound learning of the US and EU regulations on combination products

This is the case of just one regulation in the EU concerning combination products. When the regulations and their updates from both the US and the EU are taken together, a regulatory professional or anyone in manufacturing is up against a mountain. It is to help gain clarity on this wide array of topics that GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar.

This seminar, which is aimed at giving professionals who work in areas concerning regulation in the combination products area, will have Salma Michor, founder and CEO of Michor Consulting Schweiz GmbH, as the Director.

Please visit Regulations in the US and EU Dealing with Combination Products to register for this seminar. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Clarity about combination products

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Over two days of intense learning, Salma will offer a thorough understanding of the complexities involved in the regulations about combination products in the EU and the US. She will offer in-depth explanation of all the relevant regulations and guidelines. She will reinforce this learning by offering real life examples of how to register and maintain various types of combination products.

Salma will also help participants explore Interfaces, at which Change Management and LCM will be taken up for explanation. Other important aspects relating to the subject of combination products, namely compliant safety reporting for combination products and documentation requirements and interfacing, will be described in detail at this session.

Over the two days of intense learning, Salma will cover the following areas:

Documentation requirements and interfacing

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  • Documentation requirements for combination products EU
  • Documentation requirements for combination products US
  • Interfacing, development, quality, regulatory
  • Managing third parties and document control.

This seminar is of high value to professionals whose work is related in one or another way to combination products, such as Regulatory Affairs, Medical Officers, and Clinical Trial Managers.

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Rural health care centers provide low-cost care

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Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

To get dental services she can afford, 73-year-old Juanita Jenkins has one of her sons drive her 16 miles from her home in the Duval neighborhood in northeast Gainesville to the Alachua County Organization for Rural Needs (ACORN) Clinic in Brooker. The 32-mile round trip is worth it, she says.

Jenkins is one of thousands of people in Alachua County and surrounding counties who need the inexpensive services provided by nonprofit organizations, such as ACORN, which was established in 1974 to serve area migrant workers.

“I started coming here last year and I’ve been here to the dentist about four or five times,” said Jenkins, after getting fitted for dentures. “They take good care of you here, and I would recommend their services to anybody.”

Thursday is National Rural Health Day, created to recognize rural health workers for their efforts and their collaborations that address the unique challenges faced in rural communities.

Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

ACORN has grown from a singlewide trailer on a sandy lot of land to several modular buildings that house dental, medical and administrative offices at 23320 N. State Road 235 in Brooker.

The clinic provides a range of medical, dental and mental health care services, referrals to other health services and social services and professional education and training, King said.

Like ACORN, Archer Family Healthcare, an arm of the University of Florida College of Nursing, started out in a small building before moving into a larger building to better serve its patients. According to Joan Newell-Walker, manager of the clinic, retired Dr. Dee Williams lobbied to establish the clinic after being urged to do so by Archer residents. Williams’ efforts led to the clinic opening in 2001, and it has grown from an approximately 1,000-square-foot, two-story bungalow to a more than 5,000-square-foot facility composed of six modular buildings that were built in downtown Archer in 2007.

“We have grown to accommodate approximately 5,000 patient visits annually,” Newell-Walker said.

Patients visit the Archer clinic for a variety of reasons, including chronic diseases like diabetes, hypertension, chronic obstructive pulmonary disease, as well as prenatal care, medication consultations, health education and disease prevention, immunizations, physical exams and more, Newell-Walker said.

The clinic in Archer was established to meet the needs of residents who live in the rural community in southwest Alachua County who didn’t have a health care facility before the clinic opened. But it’s grown to serve patients from throughout North Central Florida, Newell-Walker said.

The clinic’s funding comes from local, state and federal sources, and it’s run by advanced registered nurse practitioners, Newell-Walker said.

The nurse practitioners provide expert care for patients and are supported by other health care professionals, including a case manager, community health nurses and a consulting physician, Newell-Walker said.

At ACORN, a wide variety of dental, medical and mental health care services are provided, including disease management education, general medical care, reduced cost X-rays, women’s health care, dental exams and X-rays, extractions, orthodontics, root canals and more.

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Innovation in education looks to cure doctor shortage

Business News | 20 hours ago |

Arizona has a serious doctor shortage. The state is a “Designated Health Professional Shortage Area” and according to the latest numbers from the Health Resources & Services Administration, the department that makes these designations, slightly less than half of Arizona’s primary care health professional needs are met.

Video by Jesse A. Millard

Since only 49 percent of the state’s needs are met, Arizona residents, particularly those in the rural parts of the state, are subject to long wait times for regular checkups because of the doctor shortage.

Arizona needs to add 520 physicians in order to lose its “shortage” designation. These doctors won’t appear out of thin air, but Arizona does have a great pool to reel new doctors from — its growing medical schools.

Midwestern University’s Arizona campus in Glendale sees an estimated 40 percent of its graduates residing and practicing in Arizona, says Dr. Kathleen H. Goeppinger, president and CEO of Midwestern University.

The University of Arizona College of Medicine in Phoenix offers a pipeline to local communities. The efforts include Saturday Scrubs and Summer Scrubs, where those interested in the medical field are welcomed into simulation labs to watch students care for mannequins — or faux patients. The hope is the program will spark the interest in those considering a career in the medical field.

And Mayo Clinic welcomed its first class of about 50 students to the Valley this year, making Arizona the third state to receive a Mayo Medical school, behind Minnesota and Florida.

The Mayo Clinic School of Medicine has created a curriculum that is designed to not only teach students how to do certain medical procedures, but also teach them the ins and outs of the healthcare delivery system.

“We want to prepare physicians to meet the needs and challenges of the healthcare system,” says Michele Halyard, MD, dean of the Mayo Clinic School of Medicine’s Arizona campus. “We are hoping that many of the students will wind up staying in Arizona for their residency and ultimately becoming a physician within the Arizona community.”

Class act

In late September, several medical groups in the state formed an alliance that will work to increase the number of doctors and healthcare professionals in Arizona and ease the doctor shortage.

Maricopa Integrated Health System, Creighton University School of Medicine, Dignity Health’s St. Joseph’s Hospital and Medical Center and District Medical Group will work together as the Creighton University Arizona Health Education Alliance to expand Arizona’s offerings of healthcare education programs.

“With this alliance, we have the opportunity to continue to strengthen Arizona’s reputation as the home of some of the best medicine in the nation,” says Patty White, president and CEO of St. Joseph’s. “The affiliation will enable us to increase the numbers of doctors and other healthcare professionals who will want to make Arizona their home.”

Arizona is also on the cutting edge of medical education, training and creating doctors who will be prepared to deliver care in a modern healthcare setting.

This is being done through various medical simulation centers in the state. Simulation is still fairly new in medical training and preparation. However, many medical schools across Arizona are adopting this new practice in hopes of producing better trained physicians.

Simulation centers vary from facility to facility, but they typically involve mannequins that enable students, practitioners and residents to learn how to deal with many different aspects of medical care and treatment.

Innovation abounds

The Banner Simulation Medical Center’s 55,000-square-foot simulation center is one of the largest simulation centers in Arizona, where trainees can fully experience a hospital-like atmosphere.

The center is nestled in a decommissioned, hospital where students can immerse themselves in simulations at an intensive care unit, surgery center, operating rooms and training labs. Students learn how to take blood samples, utilize proper sanitary measures and more, says Karen Josey, senior director of simulation at Banner Health.

“Simulation is all about patient safety,” Josey says. “Simulation goes from simple training such as putting in an IV, to the more complex tasks and scenarios, such as a chest tube insertion.”

The center also offers a day in the life of a nurse, where students are assigned a number of patients that they must watch, prioritize and care for throughout the day. This is followed by hours of debriefing on what needs to be improved and what was done correctly.

The University of Arizona currently has two simulation labs. One located in Tucson — which will open in May of 2018 — and one in Phoenix.

The Phoenix simulation center consists of three wings, 14 hospital rooms, two surgical stations, nine debriefing rooms, six onsite training rooms, three scrub sinks, ultrasound machines, 3-D models of the brain and eyes and a virtual reality simulation.

All of this is in hopes of accomplishing the UA’s “mission of providing the best training to students, residents and fellows, but it also helps recruit and expand our pipeline of students who might consider entering careers in medical fields,” says Guy Reed, dean of the University of Arizona College of Medicine – Phoenix.

Midwestern University is also home to a simulation lab. Its lab is made up of 19 exam rooms and extends to seven veterinary-based exam rooms. Also, there’s an ICU, emergency/trauma room, a pediatric floor, maternal fetal simulator, operating rooms and more.

Arizona is filled with simulation labs, including two more with Mayo Clinic. Mayo’s facility contains about six fully equipped exam rooms that are identical to those in the Mayo Clinic Cancer Center, and another simulation center within its hospital.

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Health Education England launches online workshop on improving digital readiness

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Health Education England is launching an online workshop to gather views on digital readiness.

The organisation is working in collaboration with Digital Health and innovation and crowdsourcing agency Clever Together on the online workshop, which forms part of the Building a Digital Ready Workforce programme.

It will be launched on 22 November in partnership with BCS Health and Care, the Federation of Informatics Professionals in Health and Social Care, and the Faculty of Clinical Informatics.

James Freed, chief information officer at Health Education England, told Digital Health the exercise was a chance to gather the views of those who already have a strong voice as well as those who are less commonly heard.

“In almost all technological programmes I have seen, our efforts are mostly about technology and very little about process, and the process redesign, and almost none on people,” he explained. He hopes the new online workshop will address that.

Andy Kinnear, chair of BCS Health and Care, added the aim was to hear from “digital experts; the wider group of people involved in the digital space such as nurses, doctors and care professionals; and the entire health and social care workforce”.

The online workshop will run for about three weeks and its results will form the basis for how the BRDW programme will prioritise and invest £6m over the next four years. Its findings will be extensively covered by Digital Health.

You can register now for the online workshop. Our feature article gives more detail – including interviews with James Freed and Andy Kinnear. Keep an eye on Digital Health over the next few weeks for ongoing coverage.

Women’s Forum panel addresses women’s health, education challenges

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Health and education challenges that women face were the center of a panel discussion which took place Monday morning as part of the Women’s Global Leadership Forum.

Courtesy Women’s Global Leadership Forum

 

A panel addressing health and education challenges facing women took place Monday morning as part of the Women’s Global Leadership Forum. The discussion was facilitated by Rebecca Dillingham, director of the University’s Center for Global Health, and was comprised of of women who gave their global perspectives on the issues.

Newcomb Ballroom was packed with an audience that included high schoolers, University students, alumni and faculty members.

Vivian Pinn, the first full-time director of the Office of Research on Women’s Health at the National Institutes of Health, spoke briefly about being the first African-American female graduate from the University Medical School.

“I went into that first morning class in the fall of 1963 thinking that when I looked around the room and saw only white men — that the other women and people of color must just be late getting there,” Pinn said. “Then I realized that I was it. It was me and my classmates.”

Pinn said one of her main priorities she has pursued throughout her life is trying to ensure the medical world listens to women and discusses women’s health.

“I have focused on things that have been important to me my whole life,” Pinn said. “That is — What about the health of girls and women? What about girls getting careers in medicine? I couldn’t think of a better time to focus my energy on women’s health.”

The panel centralized their conversation on the importance of enabling education at a young level to facilitate greater gender equality amongst leadership roles.

Maya Ajmera, president and CEO of the Society for Science and the Public, spoke about her trip to India in which she saw train platform schools. The trip inspired her Global Fund for Children which works on behalf of vulnerable children. Ajmera said in the future she wants to focus on empowering local, grassroots organizations to enact change.

“Grassroot entrepreneurs …  They are the ones that resources really need to get put into because I think they’ve been starved,” Ajmera said. “I think they’ve been starved in this country, but I also see that starvation globally. So if we’re going to reach people, it’s through the grassroots.”

Ajmera also said one of her main priorities is to ensure that girls continue their education beyond primary school.

“We have to get the education of girls at the secondary level globally up,” Ajmera said. “The development goals of the U.N. have achieved great success in getting primary school admissions very high. But secondary school really has to be an emphasis.”

Abinet Sitotaw, a gender and nutrition advisor for nonprofit organization CARE-Ethiopia also said education was important in promoting women and girl’s empowerment. Speaking of her own personal mission and the Mandela Washington Fellowship, Sitotaw said her priorities involved getting girls into safe educational institutions.

“It’s going to be a leadership academy whereby I manage to bring a group of young girls who cannot attend secondary schools to the city,” Sitotaw said. “I want to give them a boarding school whereby they can get a state of the art education and also leadership skills.”

 

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It is important for non-statisticians to become familiar with biostatistics

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Statistics is extremely useful as a decision-making tool in the clinical research arena. In areas such as working in a field where a p-value can determine the next steps on development of a drug or procedure, it is very handy, because of which it is imperative for decision makers to understand the theory and application of statistics.

Many statistical software applications have now been developed and made available to professionals. It needs to be borne in mind that these software applications were developed for statisticians, because of which its use can baffle non-statisticians. Their confusions could be as basic as pressing the right key, let alone performing the best test.

A full learning session on biostatistics for the non-statistician

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A seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will throw light on the importance of biostatistics for the non-statistician.

Elaine Eisenbeisz, a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California, who has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations to start-up companies and individual researchers; will be the Director of this seminar.

Want to understand the importance of biostatistics for the non-statistician? Then, please enrol for this seminar by visiting It is important for non-statisticians to become familiar with biostatistics. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Statistical concepts in clinical research

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Designed essentially for non-statisticians; this seminar provides a non-mathematical introduction to biostatistics. It will be of high value to professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

Elaine will equip participants of this seminar with the information and skills necessary to understand statistical concepts and findings as they relate to clinical research. With this information, they will be able to confidently communicate with people with whom they need to.

Elaine will place emphasis on the actual statistical concepts, application, and interpretation. She will not go into the areas of mathematical formulas or actual data analysis. A basic understanding of statistics is desired from the participants, but is not necessary.

This course on biostatistics for the non-statistician will help professionals involved in this area, such as Physicians, Clinical Research Associates, and Clinical Project Managers/Leaders, Sponsors, Regulatory Professionals who use statistical concepts/terminology in reporting, and Medical Writers who need to interpret statistical reports.

Elaine’s agenda for this two-day seminar will consist of the following:

Why Statistics?

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  • Do we really need statistical tests?
  • Sample vs. Population
  • I’m a statistician not a magician! What statistics can and can’t do
  • Descriptive statistics and measures of variability

The many ways of interpretation

  • Confidence intervals
  • p-values
  • effect sizes
  • Clinical vs. meaningful significance

Common Statistical Tests

  • Comparative tests
  • Regression analysis
  • Non-parametric techniques

Bayesian Logic

  • A different way of thinking
  • Bayesian methods and statistical significance
  • Bayesian applications to diagnostics testing
  • Bayesian applications to genetics

Interpreting Statistics – Team Exercise

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  • Team Exercise: Review a scientific paper and learn how to
    • Interpret statistical jargon
    • Look for reproducibility, transparency, bias, and limitations
    • Convey information coherently to non-statisticians

Study power and sample size

  • Review of p-value, significance level, effect size
  • Formulas, software, and other resources for computing a sample size

Developing a Statistical Analysis Plan

Specialized topics/Closing Comments/Q&A

  • Comparing Survival Curves
  • Pharmacokinetics/Pharmacodynamics (PK/PD)
  • Taking a holistic view to study design and interpretation
  • Question and Answer session.

 

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Murj wants to give data collection from implantable medical devices an upgrade

Murj, a new company backed by $4.5 million in new venture financing, is looking to make data collection from implantable heart monitoring and management devices easier and more manageable.

The company was founded by a former Medtronic sales rep who’d previously worked as a product manager on Apple’s iPads. After a few years in sales, Murj founder Todd Butka began thinking about ways to make the data collected by cardiac technologies more easily available to physicians and diagnosticians.

Now the company is coming to market with backing from True Ventures and Social Capital.

Unlike existing technologies that deliver data in static .pdf documents, Murj collects the data and stores it in its own off-premise data warehouses. Using dashboards and other visualization tools doctors can get a better read on what’s going on with their patients’ heart health, Butka claims.

“The information comes from the devices to the implantable devices’ servers… We ping the servers,” Butka explained.

The Murj launch wraps up three years of work developing the technology, which was founded in 2014 and raised its first money in 2015.

The company, based in Santa Cruz, brought on Chris Irving as its lead designer and Patrick Beaulieu, an 18 year veteran of the medical device business, as its chief technical officer.

I think of the company as sort of an Apple Healthkit for implantable devices. If it can expand its scope beyond pacemakers and heart monitors to a broader range of implantables, it could be a pretty big business.

As the population ages, and technologies improve, demand for more persistent diagnostic tools will grow.

In a sense this is part of a number of companies that are trying to provide better tools to manage the data coming off of the sensors that we’ve got all around us.

 

Read More: http://snip.ly/kvqol#https://techcrunch.com/2017/04/18/murj-wants-to-give-data-collection-from-wearable-devices-an-upgrade/