Health and Medicine

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…

Pharmacology 2018 welcomes attendees, presenters, and exhibitors from all over the world to Tokyo, Japan. The event brings together truly innovative thinkers who are leading the way through current perspectives in drug research and development. We are delighted to invite you to attend and register for the “International Conference on Pharmacology” (Pharmacology 2018) which is going to be held during June 18-20, 2018 at Tokyo Japan. The organizing committee is gearing up for an exciting and informative conference program including plenary lectures, symposia, workshops on a variety of topics, poster presentations and various programs for participants from all over the…

The 24th Annual Update And Intensive Review of Internal Medicine provides a rigorous review of current concepts in internal medicine and sub-specialties over 5 days. Presented by Columbia University Medical Center's world-class faculty and clinician-educators who are thought-leaders in their respective fields. Case-based didactic lectures and interactive board review sessions. This course is designed to provide a comprehensive review of the most important advances that have recently been made in internal medicine, and to help candidates prepare for the Internal Medicine Boards or the Recertification Examination. Each of the major sub-specialties will be covered including cardiology, endocrinology, gastroenterology, hematology, infectious…

With the same-sex marriage debate resolved in Australia, the next flashpoint may be the phenomenon of transgender people asserting their personal and civil rights. Is gender diversity a case of social engineering, or is it a fact of life with important social justice dimensions? Prominent transgender Australians now regularly appear in the media, and controversy on this issue - especially about gender-diverse youth and education - is a common feature of media and social media commentary. It\’s time, therefore, for a solid understanding of the terms and concepts involved in the topic of gender diversity. It’s also time to gain…

The 4th EAN Congress will take place in Lisbon, Portugal from 16-19 June 2018. The overarching theme for the Lisbon congress will be 'Neurogenetics'. Diagnosis and treatment are increasingly using genetic methods and one purpose of the congress is to highlight clinically useful aspects of genetic medicine in Neurology. But as always, progress in all fields of neurology will be presented and participants will be updated about recent developments and news in clinical neurology. There will be nine Symposia on various main topics such as Movement Disorders, MS and Epilepsy as well as 16 Focused Workshops, focussing on specific topics…

Um den Onkologen im gesamten deutschsprachigen Raum die aktuellen Neuerungen im diagnostischen und therapeutischen Bereich der Onkologie kompakt zu vermitteln, wird der Onko 3-Länder-Update Spezial vom 15. – 16. Juni 2018 in München durchgeführt. Dabei informieren ausgewiesene Experten aus Deutschland, Österreich und der Schweiz über die aktuellen Trends der (inter)nationalen klinischen Onkologie-Therapie und -Forschung. Neben den wichtigsten chemo- und immun-therapeutischen Behandlungen von zahlreichen Organkrebsarten werden im Besonderen die Möglichkeiten und Herausforderungen innovativer diagnostischer Methoden fokussiert und im Plenum diskutiert. Diese praxisorientierte Fortbildung bietet in 16 Stunden: - ein umfassendes Update für Onkologen und Hämatologen - ein Kursbuch mit den Power-Point-Präsentation…

This highly practical, educational meeting will offer clinically useful information in an interactive, learning-focused format and up to 14 CME Credits, including your entire year's ABPN Self-Assessment (SA) Requirement, plus credit towards your Maintenance of Certification (MOC). Our nationally known faculty will present recent advances and emerging trends in the treatment and monitoring of patients with neuropsychiatric disorders, and the clinical implications of neuropsychiatry will be the focus throughout.The conference will offer an outstanding opportunity for peer-to-peer learning and networking. With frequent question and answer with faculty and panels, there is ample time to share best practices and find solutions…

Premier Publishing s.r.o. (Austria-Czech Republic) invites you to participate in the IV International Conference on Biology and Medical Sciences: Innovations and practice, which will be held in New York on 14 June, 2018. The conference will be conducted in distance way without necessity of personal presence. We invite students and postgraduate students, postdoctoral students, employees of educational institutions, without regard to the country of residence, to participation in the conference. Articles for the conference proceedings are accepted till June 14, 2018 inclusive. Working languages: English, German, Russian, Ukrainian. Example of output data of an article: Mark, Smith. New approaches to…

SOGETI GREEN X GAMES — par SOGETI 48h pour creer le meilleur Green Game (et faire proliferer les licornes) ! Sogeti s’engage pour l’environnement et vous lance un defi : realiser en 48h le meilleur green game! A l’occasion de cette compétition, venez affronter les meilleures equipes avec vos idees les plus innovantes. Votre week-end sera rythme par les defis lances par nos coachs, les buts de l’equipe de France, les pauses gourmandes et de nombreuses autres surprises et cadeaux ! Votre mission : Mouiller le maillot pour sauver le monde ! Choisir un theme environnemental Choisir un style de…

This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses. Areas Covered in the Session : Global Harmonization Task Force requirements (includes FDA and ISO) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Design Qualification Facilities and utilities Strategies for achieving a robust and reliable process. Typical process validation protocols Who Should Attend: Research and…

14 expert speakers from across Europe will summarize the most relevant scientific information for practitioners to implement into their daily work. A complete take-home compendium, including all presentations, will be handed out at the congress. The Gastro Update Europe provides many opportunities to interact with the experts; during the lecture, in the Speaker's Corner and during Interactive Case Discussions. The Update specialities include: -IBD -Oesophagus/Stomach/Duodenum -Oncology -Hepatology -Surgery: Upper GI Tract -Surgery: Lower GI Tract -Endoscopy: Upper GI and Small Bowel -Endoscopy: ERCP and EUS -Endoscopy: Lower GI -Pancreas -Motility and Functional Disorders -Large Bowel -Small Bowel Diseases Following 12…

Course "SOP Development and Implementation for the FDA-Regulated Industry " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs. Why should you attend: One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and…

Course "Project Management for Non-Project Managers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This two-day seminar will begin by laying the foundation for the subject by first defining what a project is and then discussing the unique roles that the project manager must assume along the length of any project. The Triple Constraint, the most fundamental of project management principles, will be explained in detail with examples and tools provided that can be used to integrate the principle into any project management process. Each stage of…

eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints! This session will include the requirements for all of the above responsibilities,…

Course "Evolution of the Quality Management System - How to go from Surviving to Thriving" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Using lecture, discussion, and exercises, this 2 day seminar will focus on taking your QMS from surviving to thriving. We'll move from understanding the regulatory requirements, how to create your QMS structure, process thinking, and developing your improvement strategy. We'll discuss tools and techniques for improvement and how to measure your progress. Location: Baltimore, MD Date: June 14th & 15th, 2018 and Time: 9:00…

Course "Applying ISO14971 and IEC62304 - A guide to practical Risk Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a…