Health and Medicine

Access Healthcare Market Through a Solution-Driven Approach by Leveraging Internal and External Influences Pharmaceutical companies are turning to their medical affairs function to boost interactions with critical payer groups such as Accountable Care Organizations and Integrated Delivery Networks. As value-based drug contracting between manufacturers and payers continue to move forward, and the healthcare industry turns away from fee-for-service, public and private payers are pushing providers to take on more financial accountability for their services through alternative payment models. The 11th Partnering with ACOs & IDNs Summit will provide a platform for collaboration to advance ACO, IDN, and life sciences partnerships…

DISCOVER WHY THE 9TH DIGITAL PHARMA WEST IS THE NUMBER-ONE PROVIDER OF CONTENT, INNOVATION AND PRACTICAL INSIGHTS ON THE WEST COAST Join us June 11-13 for the 9th Digital Pharma West conference where more than 300 life science industry marketers will gather to learn and network together to discuss the latest in digital marketing advancements within the industry. Hear from nearly 40 marketing leaders as they discuss some of the biggest topics in the industry today: - Digital/Commercial/Business transformation - Patient solutions - External collaboration with digital health companies, startups and non-traditional tech - Real-world evidence data and analytics -…

ExL's 9th Aggregate Spend and Open Payments Conference has been the industry's premier event for strategies to optimize transparency reporting for compliance programs for almost a decade. This year, we will explore compliance theories about how to match transparency-reporting processes with continually evolving business systems and promotional activities. URLs: Brochure: https://go.evvnt.com/214426-1?pid=154 Booking: https://go.evvnt.com/214426-2?pid=154 Time: 8:00 am to 6:00 pm Prices: Early Bird Pricing — Register by May 4, 2018: USD 1895, Standard Pricing: USD 2095, Onsite Pricing: USD 2195

The growing biotech industry has led to an increasingly competitive and saturated marketplace, and with it, greater competition for face time with premier thought leaders. Coupled with the scrutiny associated with industry partnerships and the challenges of managing KOL relationships in a post-Sunshine Act world, it is imperative for life science organizations to differentiate themselves from their competitors in the marketplace while aligning company objectives across their internal organization. The 9th KOL/Thought Leader Engagement and Advisory Boards Summit will provide attendees with valuable insights into engaging traditional and non-traditional KOLs and discuss the priorities and motivating factors for patient groups,…

Overview: Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training. Why should you Attend: The laws that govern Good Manufacturing Practices (GMP) are a cornerstone of pharmaceutical production. Still, many companies fall short of the requirements that are written into US, UK, European and other laws, which can have disastrous consequences for patient health and a company's reputation, not to mention the resultant losses in revenue due to fines, declining sales and withdrawal of products from the market. Areas Covered in the Session: Food and drug oversight Pivotal…

as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world. Regulatory bodies are placing increased emphasis on risk management, and technology shifts are…

This webinar provides an overview of the Quality Management System requirements. We will discuss ISO Quality Management standards and the FDA Quality System requirements. Medical device companies are utilizing ISO standards to build their business management systems because of their benefits and as a necessary step to market their products globally. Areas Covered in the Session : >. Understand the Quality Management Principles >. Discuss the benefits of an effective QMS >. Review the Quality Essentials >. Procedure Development >. Understand the required documentation: >. Quality Manual >. Policies >. Procedures >. Work Instructions Who Should Attend: >. Quality Associates…

“In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.” Why You Should Attend: This webinar will first explain the various US and international regulatory requirements for various clean room classifications, as well as the environmental monitoring of clean room environments. Next, the presentation details the benefits,…

Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.” Why You Should Attend: This…

This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. This Medical device training will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company’s regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. Areas Covered in…

This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for estimating process capability (e.g. establishing process stability) are discussed first. Distributions are briefly described and methods for estimating ppm levels are presented. The use and limitations of common process capability indices (e.g. Cpk and Ppk) are discussed. It is vital that appropriate methods are used for estimating capability when the data is not well described by a normal distribution. Failure to do so often results in overly optimistic process capability estimates. Methods for testing for normality are discussed. Both transformations and distribution fitting are…

Just as school let's out for summer and insanity ensues, we want to provide moms with a mindful reset. Power your happy at DFWChild's Mom Zen presented by the YMCA. Put those yoga pants of yours to good use as we take over the zen-like garden of the Nasher Sculpture Center. Take your pick of either morning yoga or pilates lead by the Y's experienced instructors. Light breakfast bites, mimosas, and coffee will be served immediately following each 30-minute practice. While you nosh, relax even further with chair massages, skincare demonstrations, giveaways, and more. Feel good while you do good.…

Since 1966, the International Atherosclerosis Society (IAS) has held triennial meetings to bring together leading atherosclerosis researchers from across the globe. In its current form, the International Symposium on Atherosclerosis brings together scientists from over 65 constituent societies with over 17,000 active members. It remains today the premier meeting for international atherosclerosis research. In keeping with the time-honored tradition of this worldclass symposium, ISA 2018 will bring together top clinicians, researchers, and health practitioners from around the world. In addition to delivering a comprehensive and high quality scientific program, this meeting will also provide an opportunity for its attendees to…

The 5th Singapore Hepatology Conference and the best of EASL (SHC-EASL) 2018 will take place at the world-class Suntec Singapore Convention & Exhibition Centre from 8 - 9 June 2018. The 4th Singapore Hepatology Conference and the best of EASL (SHC-EASL) 2017 was an outstanding success with over 600 participants from 30 countries. SHC 2018 will cater for all hepatology-related specialists with an excellent scientific programme that includes a multi-disciplinary approach to the assessment, diagnosis and treatment strategies for the eradication of HBV, HCV, NASH and HCC. With exciting internationally renowned speakers, and a very good clinically orientated programme together…

Training Options Duration: 60 Minutes Friday, June 8, 2018 | 10:00 AM PDT | 01:00 PM EDT Overview: That childhood ADHD predisposes to increased risks for impairment in educational, family, peer, and eventual occupational functioning by young adulthood, among many other major domains of life activities is well established in research. Less appreciated is that the disorder also predisposes to increased health, medical, and dental risks, such as an increased risk for accidental injuries across the lifespan. And ADHD also predisposes to certainly personality traits and lifestyle choices that have a significant impact on these health related factors. Such risks…

Overview: It is essential for industry to employ efficient and accurate strategies for monitoring outsourced projects to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, and quality monitoring and risk minimization when outsourcing activities in GXP areas to remain compliant. Areas Covered in the Session: Discover Tools and Processes to Manage CROs/other Vendors Gain an insight for CROs/other Vendors of what Sponsors Expect and how to Meet their Expectations Measuring CRO Performance including Metrics and Key Performance Indicators Managing and avoiding common pitfalls with CROs/Vendors…

Overview: This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity. Areas Covered in the Session: Ensure data integrity, security, and protect intellectual property Understand the current computer system industry standards for security, data transfer, and audit trails Electronic signatures, digital pens, and biometric signatures SOPs required for the IT infrastructure Product features to look for when purchasing COTS software Who Will Benefit: Quality Assurance Quality Control Laboratory Staff Managers GMP, GCP, GLP Professionals Speaker Profile: David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11,…

This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product. Areas Covered in the Session : >. How these two different concepts are integrated (Phase 1, 2,and 3 vs. Stages 1, 2, and 3) >. Where do they merge? >. Do they exist independently of each other? >. Do they complement each other to enhance, build and provide a…

Human Error occurs in all settings. In the world of pharmaceutical manufacturing, the result of that error can result in loss of product or at the most extreme, injury to patients. Human is a frequent occurrance in pharmaceutical manufacturing. It occurs even when every obvious preventive actions have been employed such as effective compliance documentation development and training. Areas Covered in the Session : >. Understanding Human Error >. Nature of human error in pharmaceutical manufacturing >. Approaches to investigating Human Error >. The root causes that are directly attributable to Human Error >. The role of leadership in Human…

Oxford Global is proud to present the 2nd Annual Microbiome Discovery and Development Congress, taking place on the 7-8th June 2018 in Berlin, Germany. The conference showcases world-class senior industry experts presenting case studies on the most exciting issues in the microbiome field, covering novel strategies in microbiome research, the latest therapeutic trends, and the challenges and opportunities involved in commercialising microbiome therapeutics. View Agenda: http://bit.ly/2BOsODK The congress will cover 2 areas focusing on: • Novel Strategies & Technologies for Microbiome Drug Discovery • Therapeutic Potential of the Microbiome • New for 2018! Workshop on commercialising microbiome therapeutics. Further sessions…