Health and Medicine

Combination Products Lifecycle Management Summit is dedicated to serve 60+ senior leaders in Combination Products Program Lead, Commercial, Quality and Regulatory Affairs to benchmark LCM best practice, mitigate risks and innovate to extend drug-device product life. URLs: Brochure: https://go.evvnt.com/212432-1?pid=154 Booking: https://go.evvnt.com/212432-2?pid=154 Time: 8:00 am to 5:00 pm Prices: Standard: USD 2799, Early Bird (By May 11): USD 2599, Early Bird (By April 6): USD 2399 Speakers: Mathias Romacker (Pfizer), Matthew James Clemente (Eli Lilly), John Schalago ( EMD Serono), Steve Bowman (Shire), James Wabby (Allergan)

SDD is industry's first networking and discussion forum dedicated to solving translational challenges limiting the development of disease modifying scleroderma therapeutics. With up to 90% of the estimated 2 million affected by systemic sclerosis worldwide developing some degree of lung scarring – the capability of candidates targeting idiopathic pulmonary fibrosis and other manifestations of interstitial lung disease provides promise for the successful re-direction of anti-fibrotic, anti-inflammatory therapeutics into other aspects of SSc multi-organ manifestation. Bringing together leading researchers from academia and industry, this timely and important meeting will benchmark candidate successes, comprehensively review what is known about disease aetiology and…

Course "21 CFR Part 11 compliance for software validation and SaaS/Cloud" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: • This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. • Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants…

Course "Project Management Overview for Auditors" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: What are the basic steps for implementing a project using Project Management methodology? What role will I have to play in implementation? What happens if I've never worked on a Project of this size before? This class will explain what Project Management is and provide tools for understanding, and participating in, a Project. We'll cover how to write a clear and concise project statement, the basic phases of Project Management, and how to…

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…

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…