Health and Medicine

Overview: This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. Why should you Attend: This webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. Areas Covered in the Session: System Risk Assessment GAMP 5 "V"Model…

Following the success of the CRISPR Congress in Boston and the launch of CRISPR Congress in Berlin, we are now building a CRISPR community on the West Coast for the genetic/gene editing research community in addition to getting into the burgeoning stem cell market The inaugural Precision CRISPR Stem Cell Congress Seattle 12-14 June 2018, founded in partnership with the Allen Institute, will help the large pharma, biotech and academic community overcome efficiency, specificity and delivery challenges to optimise the application of CRISPR gene editing of stem cells. Showcasing cutting edge data from key opinion leaders who are pushing the…

Course "Applied Statistics, with Emphasis on Verification, Validation, Sample Size, and Risk Management, in R&D, Manufacturing, and QA/QC" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: • ISO standards and FDA/MDD regulations regarding the use of statistics. • Basic vocabulary and concepts, including distributions such as binomial,…

ESS 2018 is committed to excellence as the conference gives everyone working in the area the opportunity to come together to share information and network with colleagues. The programme has been designed as a training platform for Therapists, Nurses, Therapy Assistants, Clinical Engineers, Clinical Technicians, Suppliers, Managers, Healthcare Professionals and Students to participate in the Seating and Assistive technology assessment and provision process. The conference is suitable for foundation, intermediate and advanced levels of knowledge. The acclaimed speakers will travel from around the world, and are leading professionals in the areas of Specialised Seating and Assistive Technology, Occupational Therapy, Physiotherapy…

Product Format: Live Webinar Presenter: Dorothy D. Steed, CCS, CDIP, COC, CPCO, CPUM, CPUR, CPHM, CPMA, ACS-OP, CCS-P, RCC, RMC, CEMC, CPC-I, CFPC, PCS, FCS Conference Date: Tuesday, June 12, 2018 Aired Time: 1:00 pm ET | 12:00 pm CT | 11:00 am MT | 10:00 am PT Length: 60 minutes Price: $197.00 Behavioral health challenges are frequently identified in primary care or emergency center encounters. How does the behavior affect management of medical problems? Join this session, where auditing and training expert Dorothy D. Steed will review multiple types of behavioral health encounters and documentation elements that payers seek…

Changes in the FDA’s regulation of software makes life a lot easier for medical device manufacturers. FDA faced an overwhelming challenge when it started to develop a regulatory program beyond the basic Quality System regulation and the Software Guidance issued in 2002. Congress and FDA have made huge changes in FDA’s legal jurisdiction, and FDA has made dramatic revision of its regulatory program. FDA no longer regulates low risk software, premarket guidance documents must be revised or withdrawn, firms can give themselves 510(k) market clearance rather than FDA, firms can substitute requirement of Reports of Corrections and Removals by participating…

Operating a commercially viable chemical process requires a good chemical synthesis to start with, but is also subject to the interplay of a myriad of important physical phenomena - heat transfer, mass transfer, fluid flow, etc. which are traditionally the realm of the chemical engineer. An understanding of these scale-up phenomena is crucial for the laboratory development of processes that will scale successfully. This course presents an overview of these issues and examines their impact on process operation in the pilot plant and beyond, including scale-up considerations for route selection, raw material charging, reaction steps, workup, crystallization, product isolation, drying,…

Developing safe processes is of paramount importance to any chemical company. Exothermic chemical reactions in batch and semi- batch processes can result in serious injury to people and plant if they get out of control. Results of thermal runaways include violent loss of containment, possibly explosion and the release of flammable or toxic materials to the environment. Employers are bound by Health and Safety legislation to ensure the safety of their employees and those outside their employment who might be affected by their activities. Chemical manufacturers must therefore be aware of all potential dangers in their processes and take steps…

If you are suffering from any of these conditions: Arthritis, Back Pain, Neck Pain, Knee Pain (incl. ACL/MCL/PCL/Meniscus Tears), Hip Pain, Shoulder Problems, Wrist, Foot and Ankle Joint Problems, Joint Degeneration, Neuropathy and most similar joint problems. LEARN ABOUT THE #1 NON-INVASIVE, REVOLUTIONARY STEM CELL and REGENERATIVE MEDICINE TREATMENT FOR JOINT PAIN RELIEF OF THE 21ST CENTURY NOW AVAILABLE IN DENVER, COLORADO. Join and RSVP today for our FREE Educational Seminar to learn how you can get back to an active and pain-free life without INVASIVE Surgery and HARMFUL Medications. **RSVP is required (Click "Register" Button) WHY YOU SHOULD ATTEND:…

Join Oxford Global for the 2nd Annual Precision Medicine Congress, 11-12 June 2018, Munich as our panel of over 40 world class speakers discuss the latest regulatory updates, biomarker developments, information technologies and companion diagnostics for personalized therapies. View Agenda: http://bit.ly/2BF20WZ Across two days, our event will bring together over 200 senior level attendees from academia, research institutes and pharma companies to discuss the current challenges and future perspectives of precision medicine. Over 40 presentations and case studies focusing on the key developments in precision medicine regulation, biomarkers, clinical development, digital technologies and diagnostics. 4 interactive streams: • Precision Medicine,…

For drugs anywhere, it's the safety in patients which is a huge issue, constantly under surveillance, irrespective of where the drug is in its pipeline. The Global Pharmaceutical Market currently has a market value of $1057 billion. If a drug is found to be unsafe, causing serious side effects, it can have a huge knock on effect on revenue, causing huge losses to pharmaceutical companies manufacturing the drug. Drug Safety 2018 aims to discuss the latest findings and current thinking on pharmacovigilance. Importantly, it will address the newest regulatory updates and interpretations of them, including the impact of the vital…

With the EU MDR and IVDR transition periods flashing before our eyes, alongside on-going global regulatory updates, now is the time to ensure you have the strategies and resources in place to meet these key compliance deadlines. On 11-15 June 2018, 450+ medical device, diagnostics and combination product experts will be gathering in Brussels at the MedTech Summit to discuss the latest regulatory updates, expectations, and challenges across 8 key areas: - EU Medical Device Regulation - EU Medical Device Law - Clinical Evaluations & Investigations for Medical Devices - Post Market Surveillance & Vigilance - Medical Device Regulatory Affairs…

The Payer Partnership Forum convenes professionals from healthcare payers and providers and life science organizations to discuss the conception and execution of successful and worthwhile partnerships. This forum will help professionals who are eager to engage in payer partnerships to build trust and goals between life science organizations and payers alike. The expert speaking faculty will share proven strategies to successfully initiate, monitor and sustain a partnership that achieves both parties' goals while defining the steps to ensure organizational discipline. The attendees of this conference will walk away able to establish and maintain strong partnerships with payers to decrease expenditures,…

The 67th International Pharma Partnering Conference will be attended once again by Executive Decision Makers in Pharma Business Development from all over the world. euroPLX is the unrivalled partnering platform for new business opportunities since 23 years, providing one of the most advanced online interaction and matchmaking systems around that facilitated more than 15,000 one-on-one business negotiations in 2017. Licensing deals, product acquisitions, co-marketing, mergers, or joint development projects for more than 1,600 companies from over 80 countries attest to the success story which will be continued with euroPLX 67 Noordwijk. Deals range from innovative to generic, prescription or OTC…

Euro Metabolomics 2018 will be a platform to investigate on recent research and advancements that can be useful to the researchers. Metabolomics is a rapidly emerging field to identify and quantify cellular metabolites of a biological system at a particular point of time by using sophisticated analytical techniques. Most recent innovations covered in the conference are Metabolomic Modelling and Drug Design, Precision Medicine, NMR, LC-MS, GC-MS, Mass Spectrometry, UPLC and Ion mobility spectrometry analytical methods, Targeted Metabolomics, Biomarker Metabolomics, Cancer Metabolomics, Metabolomic Profiling, Metabolomic Fingerprinting, Lipidomics, Data analysis using Systems Biology approach

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…