“We have seen firsthand the value such tools can create for life science organizations. With the release of this new paper, we’re hoping to highlight that value as well as some of the concerns that come with tool adoption and implementation.”

LEXINGTON, Mass. (PRWEB)
November 26, 2019

Cognition Corporation, a software company specializing in medical device compliance and commercialization, has just released a new eBook on adopting compliance software tools in life science product development.

Compliance software tools are often leveraged by life science organizations to manage the complexities of compliance with regulatory requirements and international standards. These electronic systems offer development teams distinct advantages in both the premarket and postmarket management of their products.

“As a vendor of a compliance software ourselves,” says David Cronin, CEO of Cognition Corporation, “We have seen firsthand the value such tools can create for life science organizations. With the release of this new paper, we’re hoping to highlight that value as well as some of the concerns that come with tool adoption and implementation.”

The new white paper outlines some of the key benefits compliance software adoption can bring to life science organizations, including the streamlining of necessary compliance activities and greater levels of accountability. It further goes on to explore some of the key challenges that companies need to consider before they move forward with adoption.

“As with any other part of the total product life cycle and quality management system for life sciences, there’s a certain amount of risk involved with implementing new software,” says Mr. Cronin. “Rather than just extolling the benefits of a compliance platform for life science businesses, we wanted to use this white paper as an opportunity to explore the fuller picture.”

Mr. Cronin adds that he hopes using this white paper to provide a clearer frame into the world of compliance software adoption, businesses looking to make a transition to newer tools are armed with the most information possible. “We understand how critical the decision to take on any new tool can be in product development, and we hope we can leverage our experience and share what we know with those who need it.”

The eBook is available for download here.

Cognition Corporation, based in Lexington, Massachusetts, has offered solutions for product development compliance for more than fifteen years. Cognition offers the Cognition Cockpit® Platform, along with engineering and validation support, and industry expertise. Thousands of users worldwide use Cognition solutions to manage their product development process and meet regulatory, performance, and-time to-market goals. For more information, visit http://www.cognition.us or call (781) 271-9300.

Share article on social media or email:

We are thrilled to offer the opportunity for our colleagues to learn directly from Dr. Als

CINCINNATI (PRWEB)
November 25, 2019

The National Association of Neonatal Therapists (NANT) will host a live, 120-minute Virtual Summit with live Q & A on Wednesday, December 4th from 1:00 – 3:00 PM EST in webinar format.

The special guest presenter will be none other than the esteemed Dr. Heidelise Als from Harvard Medical School and Boston Children’s Hospital. This presentation will inform participants of the importance of reading the newborn infant’s behavioral language astutely. Participants will also learn about the ways that care and the environment support and protect or challenge and threaten the immature infant’s brain development. The importance of the parents in nurturing and regulation of their infants at all times will be highlighted.

“This content, presented by the originator of the program, must be well understood and integrated by all neonatal professionals in order to collaboratively provide the best care possible for infants in the neonatal intensive care unit,” states NANT Founder and President Sue Ludwig, OTR/L, CNT. “We are thrilled to offer the opportunity for our colleagues to learn directly from Dr. Als.”

The Newborn Individualized Developmental Care and Assessment Program (NIDCAP) – Promise to Protect the Preterm Brain is a complimentary virtual event. It will include a Q & A session at the conclusion of the program, and a recording will be made available to all registrants.

This course offers CE Credit for OTs, PTs, SLPs and Nurses. Learners must attend and complete the entire presentation. Participants who complete the recorded presentation must also complete a learning assessment in order to receive CE Credit. No partial credit will be awarded.

“The structure of this annual online event is ideal for introducing highly relevant subject matter to a global audience,” said Ludwig.

Attendees must register for The NANT Virtual Summit in order to attend the 120-minute webinar. Visit http://nantvirtualsummit.com to register and for more information. This is time sensitive, as the Summit takes place on Wednesday, December 4th.

The National Association of Neonatal Therapists (NANT) is an organization created specifically for neonatal occupational therapists, physical therapists, and speech-language pathologists. NANT provides multiple ways for neonatal therapists to connect, learn, mentor, and inspire while advancing this focused field of therapy on a global level.

Questions regarding CE credit should be directed to the National Association of Neonatal Therapists at info@neonataltherapists.com or (866) 999-5524.

Share article on social media or email:

“It is important to understand that the Molecular Therapy family of journals offers unprecedented opportunities to publish high-quality articles in gene and cell therapy,” Herzog says.

MILWAUKEE (PRWEB)
November 25, 2019

The American Society of Gene & Cell Therapy (ASGCT) announced today the appointment of Roland W. Herzog, Ph.D. and Gerhard Bauer as editors-in-chief of the Society’s field-leading journals, Molecular Therapy and Molecular Therapy—Methods & Clinical Development, respectively. Both editors will begin their positions effective January 1, 2020.

Herzog, currently the editor-in-chief of Molecular Therapy—Methods & Clinical Development, will assume the same role for a five-year term at Molecular Therapy from Seppo Ylä-Herttuala, M.D., Ph.D. at the conclusion of Ylä-Herttuala’s term. Herzog is also a professor of pediatrics, Riley Children’s Foundation Professor of Immunology, and director of the gene and cell therapy program at Indiana University.

“It is important to understand that the Molecular Therapy family of journals offers unprecedented opportunities to publish high-quality articles in gene and cell therapy,” Herzog says. “My vision has continued and even further strengthened close coordination and collaboration between the journal editors and partnership with Cell Press and ASGCT.”

Bauer replaces Herzog at the helm of Molecular Therapy—Methods & Clinical Development after serving as an associate editor of the same journal for more than four years. Bauer is an assistant professor of hematology and oncology and director of the Good Manufacturing Practice (GMP) laboratory at the UC Davis Institute for Regenerative Cures.

“Over the years that I have been looking at manuscripts submitted to the journal, I have always loved the articles dealing with translational research, getting the products ready for clinical applications, improving their utility and solving problems in the manufacturing of these products,” Bauer says. “Now, at a time where we have clinical efficacy and also commercially approved cell and gene therapy products that save lives, it is even more important to strengthen the translational research field.”

ASGCT’s official journal, Molecular Therapy is the leading journal for research in the areas of gene transfer, vector development and design, stem cell manipulation, development of gene-, peptide-, protein-, oligonucleotide-, and cell-based therapeutics to correct genetic and acquired diseases, vaccine development, pre-clinical target validation, safety/efficacy studies, and clinical trials. Molecular Therapy is dedicated to promoting the sciences in genetics, medicine, and biotechnology. Publishing important peer-reviewed research and cutting-edge reviews and commentaries, the journal continues to attract the best material in the field. Molecular Therapy’s 2018 impact factor is 8.402.

The aim of Molecular Therapy—Methods & Clinical Development is to build upon the success of Molecular Therapy in publishing important peer-reviewed methods and procedures, as well as translational advances in the broad array of fields under the molecular therapy umbrella. Molecular Therapy—Methods & Clinical Development’s 2018 impact factor is 4.875.

In addition to Molecular Therapy and Molecular Therapy Methods & Clinical Development, ASGCT also owns and operates two other sibling journals, Molecular Therapy—Nucleic Acids (2018 impact factor 5.919) and Molecular Therapy—Oncolytics (2018 impact factor 5.710).

About ASGCT

The American Society of Gene & Cell Therapy is the primary professional membership organization for scientists, physicians, patient advocates, and other professionals with interest in gene and cell therapy. Our members work in a wide range of settings including universities, hospitals, government agencies, foundations, biotechnology and pharmaceutical companies. ASGCT advances knowledge, awareness, and education leading to the discovery and clinical application of gene and cell therapies to alleviate human disease to benefit patients and society.

Share article on social media or email:

WCG FDANews Logo

FALLS CHURCH, Va. (PRWEB)
November 25, 2019

The Future of Generic Drug Competition

Deconstructing FDA and Congressional Initiatives

**An FDAnews Webinar**

Monday, Dec. 9, 2019, 1:30-3:00 p.m. EST

https://www.fdanews.com/futuregenericdrug

Nearly every day one hears a new story about the rising costs of drugs.

The FDA’s Drug Competition Action Plan (DCAP) is designed to help remove barriers to generic drug development and market entry so that consumers can get access to cost-effective medicines.

Enter Chad Landmon, Esq. and Neema Kumar, Esq., who have extensive experience in pharma law. During this webinar, they will discuss the nuances of DCAP, including efforts to improve the efficiency of the generic drug development, review and approval process; maximizing scientific and regulatory clarity with respect to complex generic drugs; and closing loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition congress intended. They’ll cover:

• What the various pathways are to expedite approval of generic drug applications and the advantages and disadvantages of each method
• How to expeditiously obtain 180-day exclusivity
• How a sponsor can forfeit exclusivity
• How REMS standards are being used to reduce generic competition and what can be done to combat that effort
• How FDA’s citizen petition process is being used to reduce generic competition and what can be done to combat that effort
• What congressional initiatives and measures are being proposed to spur generic drug competition

When one understands the new generic drug competition initiatives, one can successfully navigate the incentives that the FDA has put in place.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally

to learn about our special multisite discount.

Webinar Details:

The Future of Generic Drug Competition

Deconstructing FDA and Congressional Initiatives

**An FDAnews Webinar**

Monday, Dec. 9, 2019, 1:30-3:00 p.m. EST

https://www.fdanews.com/futuregenericdrug

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/futuregenericdrug

By phone: 888-838-5578 or 703-538-7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

Share article on social media or email:

Midland, TX Dentist, Dr. Tye Thompson, Honored as Diplomate of the AAID

A dental implant really provides benefits to patients with missing teeth. They are able to chew, function and maintain a good smile aesthetic.

MIDLAND, Texas (PRWEB)
November 21, 2019

Respected dentist, Dr. Tye Thompson of The Dental Studio of Midland, attended the 68th Annual Conference of the American Academy of Implant Dentistry (AAID). During this event he was also awarded as a Diplomate of the AAID and the American Board of Oral Implantology. Striving to offer the latest treatment options, he attended this conference and achieved Diplomate status in order to provide the most cutting-edge dental implant care to his Midland, TX patients. This year’s conference, titled “Synergy and Success,” was designed to foster the community of implant dentistry, optimize patient care and provide attendees with relationships that last beyond the conference. Dr. Thompson will use this experience to enhance the treatments he provides at The Dental Studio of Midland along with his colleagues, Drs. Jordon Green and Mallory Layman.

While at the conference, Dr. Thompson was honored as a Diplomate of the American Academy of Implant Dentistry and the American Board of Oral Implantology. The certification process to gain this prestigious recognition is comprehensive and consists of a written and oral examination that covers all aspects of implant dentistry. To be eligible, applicants must:

• Provide evidence of an active dental license
• Have seven or more years of experience in the practice of implant dentistry
• Have completed at least 75 implant cases
• Successfully complete both the Part I and Part II examination within four years

The AAID conference focused on providing clinicians with industry leading dental implant continuing education. The conference took place in Las Vegas, NV and included staff education, hands-on learning, exhibitors as well as keynote speakers. The goal of “Synergy and Success” was to provide attending clinicians with:

• The opportunity to learn from leading practitioners
• Up to 20 hours of continuing education
• Hands-on workshops and live surgery
• Access to top technologies

Dr. Thompson is applying the skills and techniques learned at the conference to his dental implant treatments at The Dental Studio of Midland. A dental implant is a lifelike tooth replacement option that mimics the proper form and function of a natural tooth. “A dental implant provides the opportunity for a patient to be restored to normal aesthetic contour and function, just as they would by having a natural tooth,” says Dr. Thompson. “A dental implant really provides benefits to patients with missing teeth. They are able to chew, function and maintain a good smile aesthetic.”

The Dental Studio of Midland offers comprehensive dental implant care, from tooth extractions to bone grafting, implant placement using guided technology and restoration. Patients can also receive sedation dentistry for added comfort. Once the dental implant treatment is complete, patients can benefit from enhanced smile aesthetics, a boost in self-confidence, improved oral health and an improved diet. With proper care and maintenance, dental implants can last patients for the rest of their lives.

Those interested in learning more about the dentists at The Dental Studio of Midland or who would like a consultation to discuss dental implants in Midland, TX are encouraged to connect with Drs. Thompson, Green, and Layman. To schedule an appointment, call 432-687-0629 or visit http://www.midlanddentalstudio.com.

About the Dentists

The Dental Studio of Midland offers comprehensive and caring dental care to patients in Midland, TX. Committed to serving custom care that patients truly need, Drs. Tye Thompson, Jordon Green, and Mallory Layman build relationships with each patient in order to understand their unique needs and goals. Both Drs. Thompson and Green completed dental training at the prestigious University of the Pacific and continue to expand their knowledge in dentistry by attending multiple continuing education courses. Dr. Layman brings her experience from the University of Texas to the team. The Dental Studio of Midland is equipped with advanced dental technology to provide patients with the highest standard of care. Drs. Thompson, Green, and Layman offer laser dentistry, Invisalign®, full mouth reconstruction, and sedation dentistry. The Dental Studio of Midland team is dedicated to providing the most efficient, least painful procedures for patients, and offer minimally invasive surgery whenever possible. To learn more about Drs. Thompson, Green, and Layman and the services offered at The Dental Studio of Midland, call 432-687-0629 or visit http://www.midlanddentalstudio.com.

Share article on social media or email:

Jessica Du Bois

FAIRFAX, Va. (PRWEB)
November 24, 2019

Jessica Du Bois, an employee benefits consultant at Business Benefits Group, was selected as one of 150 Benefits Advisors in the country to be accepted into the Health Rosetta Associate Advisor Program. She is the first benefits advisor in the Northern Virginia region with the Health Rosetta certification. Jessica’s acceptance into the program will provide her with access to experts and proven solutions to help companies effectively manage the cost and quality of their health plan.

Health Rosetta has become known as ‘The Blueprint’ for 21st century benefits, creating an outline for the best practices for designing and managing health plans. The program is represented by big names in the industry such as Tom Emerick, who is the former benefits purchaser of Walmart, and health and wellness innovators David Contorno and Al Lewis. The Advisor Program is for benefits consultants who commit to delivering 3-5 year strategies to employers, while vowing to be transparent in commission and with recommendations. The program has gained traction over the last few years because of their success in saving public and private employers 20% or more on their health plans through simple, practical, and proven approaches.

BBG would like to congratulate Jessica Du Bois for being recognized as one of the 150 benefits advisers to be accepted into the program. Jessica has exhibited continuous excellence at BBG, providing organizations and their employees with modern benefits packages that exceed standards. She also provides assistance to businesses when determining essential strategies, as well as suggestions for additional policy options when necessary. With her success in moving employers to self-funded health plans and commitment to transparent commission practices, BBG sees the Health Rosetta Advisor Program as the perfect opportunity for Jessica showcase her promise to work for employers, not insurers.

Speak to Jessica Du Bois or any of the other benefits consultants at BBG for more information about employee benefits or to receive a consultation for your company. BBG offers a variety of benefits such as health insurance packages, self-funded plans, open enrollment communications, and employee wellness programs, among other options. BBG can be contacted online at https://www.bbgbroker.com/ or toll-free by phone at (844) 201-3612. The firm is headquartered at 4069 Chain Bridge Road, Top Floor, Fairfax, VA 22030.

Share article on social media or email: