Health and Medicine

Medical device companies face ever increasing scrutiny from the FDA and other regulators. Customers demand quality and safety. The business requires efficient and effective use of resources. Without proactive and timely metrics, a company is blind to the health of its quality system. This can lead to disaster for the company or, even worse, its customers. Areas Covered in the Session : >. How to create a balanced scorecard >. How to move from lagging to leading indicators >. How to use indices or profiles to create a more complete picture of performance >. Lack of transparency in quality/compliance data…

This event is designed for pharmaceutical, biotech and medical device professionals with responsibilities in the following areas: Product Recalls Patient Safety Product Safety Product Quality QA/QC Postmarketing Surveillance Quality Systems and Engineering Quality Compliance and Audits Complaint Handling Medical/Consumer/Regulatory/Clinical Affairs Product Complaints Compliance CMO Management Business Support Coordination Product Surveillance Clinical Operations Quality Compliance QA and Supply Integration Global Device Coordination This conference is also of interest to: Drug Safety and Complaint Software Companies Consulting Firms Law Firms Inbound Call Centers Urls; Brochure: https://go.evvnt.com/186644-1?pid=154 Booking: https://go.evvnt.com/186644-2?pid=154 Price Early Bird Pricing - Conference Only - Register by April 6, 2018: USD…

This event is designed for pharmaceutical, biotech and medical device professionals with responsibilities in the following areas: - Product Recalls - Patient Safety - Product Safety - Product Quality - QA/QC - Postmarketing Surveillance - Quality Systems and Engineering - Quality Compliance and Audits - Complaint Handling - Medical/Consumer/Regulatory/Clinical Affairs - Product Complaints - Compliance - CMO Management - Business Support Coordination - Product Surveillance - Clinical Operations - Quality Compliance - QA and Supply Integration - Global Device Coordination This conference is also of interest to: - Drug Safety and Complaint Software Companies - Consulting Firms To this: Each…

The Chronic Kidney Disease Drug Development Summit is industry’s first end-to-end drug development networking and discussion forum, dedicated to overcoming challenges drug developers face in developing chronic kidney disease therapeutics more efficacious than the current standard of care. Developed in combination with experts from Boehringer Ingelheim, Bayer, Astrazeneca, Johnson & Johnson and many more, this industry focused forum focuses on lessons learnt from CKD drug development failures, molecular understanding and reclassification towards comprehensive precisions medicine and the potential of next generation therapeutics to deliver efficacy above and beyond angiotensin converting enzyme (ACE) inhibitors and ALT1 receptor antagonists (ARBs). Be part…

As the demand for information outside of approved labeling continues to rise, the FDA has been called by the industry to provide guidance that governs off-label communications. The regulatory landscape that monitors this space is often blamed for limiting the amount of information received by patients and restricting their ability to make well-informed decisions. Given the public health issues at stake and the public interest involved, it is imperative that this event details the importance of the timely communication of truthful scientific information that currently challenges pharmaceutical, biotech, and medical device professionals. The 2018 Off-Label Regulatory Compliance Congress also explores…

During clinical trials, inspections provide a framework to ensure quality and integrity of care, data and drug performance. As sponsors of clinical trials, it is important for pharmaceutical companies to ensure GCP guidelines are upheld by implementing inspection readiness. These inspections, often conducted by the FDA, EMA, MHRA and other regulatory authorities, all have unique regulations and caveats. These nuances mean that becoming — and remaining — inspection-ready can be a difficult, time-consuming battle. Because inspections can occur without notice, sites must be prepared for visits from many different stakeholders over the course of a clinical trial. Join the 4th…

Drive innovation while navigating political and regulatory uncertainty, value-based care transitions, and financial resourcing shortages MMCC gives you the knowledge and strategies you need to • Gain regulatory clarity • Adopt alternative payment strategies • Innovate care to improve quality for your populations How? Talk freely with state officials, Association CEOs, CMS, and health plans to get candid answers to your questions • 5+Medicaid Directors from Kansas, North Carolina, Washington D.C., Maryland, and more • Network with policy makers and executive leadership from ACAP, MHPA, and more Hear outcomes from case studies and implications on the latest policies and programming…

There is an emphasis on how to reduce risk and advance drug delivery technologies for current and future needs. More specifically, we aim to cover the following: - Where is the sector going? - What are the key principles to reduce failures? - What are the unknown, unknowns? - How do we design for success and what are the guiding principles? - The conference will dedicate the afternoon of day one for a wide variety of drug delivery presentations. Partnering meetings and networking will be available throughout the meeting. To summarize what to expect at this meeting: - Addresses drug…

It gives us great pleasure to invite you to the 20th European Congress of Endocrinology (ECE 2018), on behalf of the European Society of Endocrinology (ESE), the Programme Organising Committee and the Local Organising Committee. ECE is designed to support scientific and professional interaction among all fields of endocrinology and metabolism, from bench to bedside, with the aim of advancing knowledge and improving patient care. Continuing the excitement and momentum of ECE 2017 in Lisbon, Portugal, the Programme Organising Committee has created a scientific programme featuring the best international, European and local experts as speakers in a versatile scientific programme…

Quit smoking / Quit Vaping / Quit Shisha seminar. Our highly successful quit smoking and quit vaping seminars are now in the UAE. We understand that you know all the health hazards associated with smoking. This may cause you stress, which in turn leads to you smoking more! That's why our seminars don't focus on the reasons why you shouldn't be smoking. Instead, we focus on the reasons you do smoke, and why you find it hard to quit. Our seminars have helped thousands of people quit in the UK. We keep the number of people on each seminar to…

We are pleased to announce the 30th Annual Orthopaedic Trauma Update 2018: A Tale of Two Cities, formerly known as The Columbia University NYC Trauma Course. With the addition of Dr. Paul Tornetta as Course Co-Director we will be offering a new format alternating the location each year between New York and Boston. This course is designed to present advanced instruction of upper and lower extremity trauma to practicing orthopaedic surgeons and residents. Participants will be updated on new techniques and philosophies in the modern management of orthopaedic trauma. Attendees will learn to identify and understand appropriate salvage procedures for…

OVERVIEW This 2-hour session will provide the attendees with experience gained in providing transition assistance to medical device companies over the last 2 years. Attendance includes examples of how to address the gaps most often observed and practical advice for managing transition activities as well as managing your certification audit for ISO 13485:2016. WHY SHOULD YOU ATTEND All organizations that are part of the medical device supply chain are required to establish a quality management system that conforms to ISO 13485. The transition period is coming to an end for the third edition of the standard and certifications to the…

La Sociedad Espanola de Cardiologia (SEC) os da la bienvenida a la ciudad de Donostia/San Sebastian y os invita a participar en esta reunion que se celebrara los dias 17, 18 y 19 de mayo de 2018. Vamos a contar con la inestimable ayuda de nuestros companeros del Hospital Universitario de Cruces y con el resto de companeros dedicados a la Cardiologia Pediatrica y Cardiopatias Congenitas de los otros hospitales. Entre todos y fundamentalmente de mano del Comite Cientifico, estamos elaborando un programa atractivo y de calidad, que sea de interes para todos, donde esten representadas todas las propuestas de…

The leading U.S. event devoted to building the skills, speed and teamwork of your promotional review committee members will take place May 17-18, 2018 in Chicago, IL. The 5th Promotional Review Committee Compliance And Best Practices - Midwest conference is set to bring together more than 100 professionals to ensure your PRC is prepared to generate, collect and constructively act on expert comments for your entire drug and device portfolio. URLs: Brochure: https://go.evvnt.com/200684-1?pid=154 Booking: https://go.evvnt.com/200684-2?pid=154 Prices: Conference Only Early Bird Pricing - Register by April 6, 2018: USD 1795, Conference + 1 Workshop Early Bird Pricing - Register by April…

Regulation proposals of the European Commission Background In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject. The revisions therefore affected all kinds of medical devices…

Process Validation General Principle and Practices - Philadelphia 2018 Course "Applied Statistics for FDA Process Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle: Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on…

Course "FDA Scrutiny of Promotion and Advertising Practices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely…

Investigator meetings are essential to successfully train clinical sites as they directly affect a sponsor's ability to collect accurate safety and efficacy data. A well-executed investigator meeting cultivates a crucial team atmosphere and is an opportunity for sites and sponsors to discuss the protocol, regulatory issues, enrollment criteria, and procedures. Having the opportunity to discuss protocol specific subjects directly with the sponsor is of great value for clinical sites. It is important is to communicate all essential information in the most time-efficient and engaging manner. Expert collaboration between the sponsor's clinical teams, meeting professionals, and vendors are required to execute…

Training Options Duration: 60 Minutes Thursday, May 17, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: This Webinar will help you establish(or re-establish for some of us) a Catheter coding foundation.Beginning with defining the common physician/specialty phrases and words we encounter we will start to understand the building blocks of Selective and Non-selective catheterizations, access sites and laterality as described by the physician documentation.What is included in these codes will be a topic for discussion as will notes or indicators as to other procedures the physician may have performed that are separately billable. The main body of the…

Product Format: Live Audio Conference Presenter(s): Thomas J. Force, Esq. Conference Date: Thursday, May 17, 2018 Aired Time: 1:00 pm ET | 12:00 pm CT | 11:00 am MT | 10:00 am PT Length: 60 minutes Price: $227.00 Many revenue recovery strategies that worked for out-of-network (OON) providers in the past are no longer effective today. Join this session with industry veteran Thomas J. Force, Esq. to improve your revenue cycle workflow. Get a comprehensive overview of what an OON provider needs to be doing, now, to earn proper reimbursement, including best practices to address fraud audits, recoupment by insurers,…