Health and Medicine

Clinical trials are a critical element of drug development. Introducing the investigational products to consenting subjects under Good Clinical Practices (GCPs), the Essential Documents are evidence of the compliant conduct of a clinical trial. Learning Objectives: >. Recognize the purpose and value of documents, files and data as assets in a drug development program >.Identify industry best practices and their use and adoption >.Distinguish paper and digital formats and understand transitioning from paper >.Demonstrate an understanding of the complete life cycle of regulatory content >.Discuss Best Practices for Essential Documents in their handling and storage. >.Discuss the benefit and challenges…

Who Should Attend: >. Records Management Specialists at Sponsors, CROs, FSPs, Vendors, Clinical Sites >. Personnel involved in set up, maintenance, and auditing of the Trial Master File >. Project and/or Study Managers >. Project and/or Clinical Trial Assistants >. Clinical Operations Administrators >. Clinical Research Monitors >. Quality Assurance Personnel >. Compliance Auditors >. Consultants working in the life science industry involved in managing regulated content >. eCTD Publishers and Content Providers at Sponsors, CROs, Service Providers, Software Providers >. Regulatory Operations Personnel >. Regulatory Affairs Professionals >. Anyone new to the eCTD Delivery Paradigm >. Professionals preparing eCTD…

The United States Food and Drug Administration (FDA) regulates labeling and advertisement for prescription drugs and medical devices among other things. The advertising for nonprescription or over-the-counter (OTC) drugs falls under the jurisdiction of another federal agency. In pharmaceutical and medical device industry, firms and their representatives distribute or disseminate scientific or medical publications (e.g., journal articles or reference information or texts even including clinical practice guidelines) that discuss off-label uses (unapproved uses) of FDA approved or cleared drugs or medical devices to health care professionals or health care entities. It is imperative that firms stay in compliance with the…

Chemical process development is generally not taught as part of degree courses in higher education; the conversion of a synthetic route used for making milligram or gram quantities of a chemical into a process for manufacturing multi-kilogram and tonne quantities is typically learnt "on the job" by chemists in industry. For many years, little chemical development work was published in the literature, until the establishment of the Organic Process R And D journal by Dr Trevor Laird (Founder of Scientific Update). Even now, "tricks of the trade" are handed down within individual company organisations, and it can be difficult to…

Leachables are impurities which originate from contact surfaces (typically the final container/closure) of the drug product. As with drug product related impurities it is important to monitor the leachables over the shelf-life of the products to ensure patient safety. Performing leachable stability studies can be challenging and is generally less understood than for typical drug product related impurities. There are several key differences between leachables and drug product related impurities which must be understood in order to design an effective stability program. This presentation will cover: what are leachables, where they come from, what are the similarities and differences in…

This session will provide the attendee a review of the current enforcement actions, audit focus, privacy, security, and breach issues, and expected regulatory changes in HIPAA, and help the compliance specialist prepare for a year of HIPAA work including responding to issues and planning for regular compliance activities. The most significant issues facing HIPAA professionals will be presented as well as the regular processes that should be in place to help avoid issues in the first place. We will discuss how to consider risk analysis as a means to planning your mitigation activities, and how to plan out dealing with…

Der Allgemeinmedizin Refresher findet vom 20. - 23. Juni 2018 in Berlin statt. Mit über 5.000 teilnehmenden Ärzten zählen unsere Fortbildungen im Bereich Allgemeinmedizin und Innere Medizin zu den beliebtesten Kursen im deutschsprachigen Raum. In kurzen, 30 – 40 minütigen Blöcken werden die neuesten diagnostischen und therapeutischen Leitlinien der Allgemeinmedizin von Spezialisten präsentiert und auf Ihre Fragen eingegangen. Dabei wird vor allem auf Praxisrelevanz und Didaktik großen Wert gelegt. Unsere Referenten sind Experten in ihren Fachbereichen mit langjähriger Erfahrung in ihrem Betätigungsfeld. Sie kommen aus renommierten Einrichtungen wie der Charité, dem Universitätsklinikum Leipzig, dem Klinikum Ernst von Bergmann Potsdam oder…

Hospital care models are transforming, and nurse practitioners and physician assistants play vital roles in the care delivery of hospitalized patients. Hospital Medicine for NPs and PAs fills your CME needs. Course Highlights - 25.25 AMA PRA Category 1 Credits™ - 25.25 ANCC Contact Hours - 10.5 Hours designated pharmacology content - Pharmacology Workshop - Critical Care Breakout - Contemporary guideline-based best practices - Clinical care pathways - Diagnostic and treatment algorithms - Common clinical dilemmas - Practicing health care provider faculty Price: Registration - General Session:USD 600.0 Time: 7:00 am to 5:00 pm

Course "Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Why you should attend: • What do the regulations say? • Navigate the FDA drug and device approval system • Prepare, construct and submit well-written IND, NDA, BLA, PMA, 510(k) and IDE submissions and regulatory filings • Navigate the FDA review process • Identify the required regulations and guidance documents for drug and biologic submissions • Use regulations and guidance…

Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements…

There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include: water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, and the general manufacturing environment. As such, there is no one size fits all investigation. Microbiological testing covers a wide range of products, processes and environments, therefore representative samples from each of these categories forms the basis of what gets investigated. Why You Should Attend: Medical device regulations in the US and the EU are foundational to the remainder of the regulations that are applied to medical…

This webinar details the methodology and related requirements adopted by CMS for developing a revised Medicare Clinical Laboratory Fee Schedule (CLFS) using rates paid by private health insurance companies, Medicaid Managed Care Organizations and Medicare Advantage plans. Key changes covered include the market-based data approach that Medicare uses to set payment rates; the switchover to a national fee schedule creating a single payment rate nationwide for each test without local variation; and the creation of a new category of tests, Advanced Diagnostic Laboratory Tests (ADLTs) and the different pricing methods and reporting periods for existing and new ADLTs. An analysis…

Der Psychiatrie und Psychotherapie Refresher findet vom 21. - 23. Juni 2018 in Berlin statt. In kurzen, 30 – 40 minütigen Blöcken werden die neuesten diagnostischen und therapeutischen Leitlinien der Psychiatrie und Psychotherapie von Spezialisten präsentiert und auf Ihre Fragen eingegangen. Dabei wird vor allem auf Praxisrelevanz großen Wert gelegt. Unsere Referenten sind Experten in ihren Fachbereichen mit langjährer Erfahrung in ihrem Betätigungsfeld. Sie kommen aus renomierten Einrichtungen wie der Charité Universitätsmedizin Berlin, dem Evangelisches Krankenhaus Königin Elisabeth Herberge und der Schlosspark-Klinik Berlin. Diese praxisorientierte Fortbildung bietet in über 24 Stunden: - ein umfassendes Update für Psychiater, Psychologen und Psychotherapeuten…

Neuro Congress 2018 is an elite stage to unite overall eminent researchers in thefield of Neuroscience Brain researchers, public health professionals, scientists, academicscientists, industry researchers, scholars to exchange about state of the artresearch and technologies. The aim of this conference is to stimulate new ideasin the various fields of neurology and neurological research. From brain imaging to neural engineering, this will help in the analysis and selectthe prosthetic to help the patients. Other reasons are, gathering ofworld-class researchers and budding talent from across the globe, showcase yourresearch and get world recognition, avail chances to interact withworld-renowned scientists, perfectly designed schedule:…

The 2018 6th Annual South Spring Hip and Knee Course will bring together a highly esteemed faculty of experts in primary and revision hip and knee procedures, as well as the intricacies of today's healthcare environment. Last year's program was a great success, attracting over 150 healthcare professionals. This will be the premier orthopedic course held in the southeast in 2018. Register now and don’t miss out on this great event. We look forward to seeing you in Key Largo, FL! Time: 2:00 pm - 11:50 pm Prices: Physician: USD 795.0 Allied Health (Nurse, NP, PA, PT, PharmD): USD 300.0…

Course "Writing & Managing Effective SOPs" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively? Most people naturally want to do a good job. Successful managers recognize this fact and seek to channel workers' efforts in ways that will…

How does our subjective experience emerge from the brain? How does consciousness relate to the physical world? These age-old, deep questions are now at last being addressed directly and broadly by neuroscience and will become crucial in the decades to come. The spectrum of consciousness-related conundrums is rapidly expanding: we are saving islands of human brain from devastating injuries, growing cerebral organoids in a vat, and building intelligent machines that perform faster and better than any healthy subject, just to mention a few. Where does consciousness arise? Where is the boundary between insentient matter and a spark of subjectivity? Society…

This seminar will provide an exploration of eCTDs and everything that happens before and after your organization produces a regulatory agency eCTD sequence. eCTD format submission delivery mandates exist for FDA submission types. Other agencies (EU, Health Canada…) are imposing eCTD format submission mandates as well. You will gain practical knowledge of the concepts, processes and tools which are utilized to produce submission ready documents, publish technically compliant eCTD sequences, transmit/deliver eCTD sequences, manage the publishing process, support eCTD lifecycle sequences, manage multiple eCTD product dossiers, and archive your eCTDs. Learning Objectives: >. Knowledge of the CTD/eCTD and its propose…

Overview: Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Food and Drug Administration. Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective. Why should you Attend: Recall of medical devices that present a hazard to consumers protects your firm from more severe action by the FDA (or other regulatory agencies). Not performing a recall correctly van lead…

Certainly the most simplistic solution to achieving compliance excellence and 483 avoidances is “to do the right things right!” But what does this really mean? I have distilled the “doing the right things right” solution into 7 separate individual keys or actions that will provide a solid foundation for the establishment of any 483 avoidance program. Why should you attend this Webinar? Because as much as we try, most regulated industries don’t have a set approach for developing a compliance program that is integrated into the fabric of their organization that is targeted to avoiding 483s, that also serves real…