Health and Medicine

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…

Biotech Outsourcing Strategies is a leading RandD outsourcing-partnering event. The expanded scope in 2018 will include Discovery Outsourcing in addition to CMC Outsourcing for both small molecules and biologics. Established in 2006 the event formula includes 4 key components as follows: Presentations - Delivered by thought leaders in the industry. Organisations who will be presenting include international Pharmaceutical companies such as Roche, Novartis, Bayer but also SME biotech and service providers who play a key role in developing new therapeutics: 1-to-1 Partnering - Facilitated by our partnering software, partnering allows stakeholders to connect, discuss outsourcing opportunities and build relationships: Exhibition…

The HPAPI Summit brings together perspectives throughout the value chain from bench to outsource, providing you with a unified outlook on the latest developments in highly potent manufacturing. As compounds become increasingly potent, the need for harmonization among distinct groups within organizations around key challenges is more acute than ever before. By involving multiple perspectives from companies of different size and experience in the field, the HPAPI Summit will enable you to understand how you can implement safe and robust practices in your own organization. Incorporating insights from Genentech, Pfizer, Vertex, SafeBridge and Boehringer Ingelheim, you will leave this conference…

As the knowledge of the microbiome continues to deepen, fundamental understanding of mechanism of action and demonstrating causality continue to improve. As such, the Microbiome Movement has become more committed than ever to work alongside innovative researchers and industry leaders to build events that focus on applied science and translate cutting edge microbiome R&D into safe, effective and commercially successful products across a number of industry-specific verticals. Positioned at the heart of pharmaceutical, agricultural, nutritional and animal health R&D, the Microbiome Movement continues to help accelerate the discovery, development and delivery of breakthrough solutions to global challenges to benefit human…

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…