Description http://www.worldconferencecalendar.com/index.php?option=com_conference Wed, 08 Sep 2010 21:07:43 +0100 FeedCreator 1.7.2 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,546/Itemid,26/ Conference name: 13th International Conference on Enterprise Information Systems (ICEIS) Venue: Beijing, China Event Date: 8 - 11, June 2011 Scope The purpose of the 13th International Conference on Enterprise Information Systems (ICEIS) is to bring together researchers, engineers and practitioners interested in the advances and business applications of information systems. Five simultaneous tracks will be held, covering different aspects of Enterprise Information Systems Applications, including Enterprise Database Technology, Systems Integration, Artificial Intelligence, Decision Support Systems, Information Systems Analysis and Specification, Internet Computing, Electronic Commerce and Human Factors. ICEIS focuses on real world applications; therefore authors should highlight the benefits of Information Technology for industry and services. Ideas on how to solve business problems, using IT, will arise from the conference. Papers describing advanced prototypes, systems, tools and techniques and general survey papers indicating future directions are also encouraged. Papers describing original work are invited in any of the areas listed below. Accepted papers, presented at the conference by one of the authors, will be published in the Proceedings of ICEIS. Acceptance will be based on quality, relevance and originality. Both full research reports and work-in-progress reports are welcome. There will be both oral and poster sessions. Workshops, providing a more interactive and focused platform for presenting and discussing new and emerging ideas or special sessions, dedicated to case-studies and commercial presentation are also envisaged: companies interested in presenting their products/methodologies or researchers interested in holding a tutorial are invited to contact the conference secretariat. - Computer Science and Internet Tue, 07 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,545/Itemid,26/ 37th Annual Meeting of the International Society for Pediatric and Adolescent Diabetes (ISPAD 2011) - Physical and Life Sciences Tue, 07 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,544/Itemid,26/ The First International Conference on e-Technologies and Networks for Development (ICeND2011) The Institute of Finance Management (IFM) Dar-es-Salaam, Tanzania Aug. 3-5, 2011 http://www.sdiwc.net/tn/index.php All the papers will be reviewed and the accepted papers in the conference will be published in the “Communications in Computer and Information Science” (CCIS) of Springer Lecture Notes Series (www.springer.com/series/7899), and will be indexed in many global databases including ISI Proceedings and Scopus. In addition, selected papers after complete modification and revision will be published in the special issues journals. ======================================================================================= The proposed conference on the above theme will be held at The Institute of Finance Management (IFM), Dar-es-Salaam, Tanzania from Aug. 3-5, 2011. which aims to enable researchers build connections between different digital applications. The conference welcomes papers on the following (but not limited to) research topics: - e-Commerce - e-Government - e-Logistics - e-Procurement - e-Services - e-Learning - Electronic Payment Systems - Mobile-Commerce - Electronic Auctions - Wireless Networks - Ad hoc and Sensor Networks - High Speed Networks - Internet and Web Applications - Mobile & Broadband Wireless Internet - Mobile Networks & Wireless LAN - Multimedia Networking - Information Ethics - Information Content Security - Data Compression - Cloud Computing - Grid Computing - Green Computing - Access Controls - Peer-to-Peer Social Networks - Data Mining - Social Search - Computer Forensics - Computer Security - Information and Data Management - Network Security - Social Networks - Real-Time Systems - Internet Modeling - Assurance of Service - Image Processing - Web Services Security - Multimedia Computing - Software Engineeing - Biometrics Technologies - Wireless Communications - Semantic Web, Ontologies - Mobile Social Networks - e-Logistics - e-Procurement - e-Services - Data Mining - Social Search - Computer Forensics - Computer Security - Information and Data Management - Network Security - Social Networks - Real-Time Systems - Internet Modeling - Assurance of Service - Image Processing - Web Services Security - Multimedia Computing - Software Engineeing - Biometrics Technologies - Wireless Communications - Semantic Web, Ontologies - Mobile Social Networks - Anti-cyberterrorism - XML-Based Languages - Soft Computing Techniques - Computational Intelligence - Mobile Networking, Mobility and Nomadicity - Ubiquitous Computing, Services and Applications - Forensics, Recognition Technologies and Applications - Fuzzy and Neural Network Systems - Signal Processing, Pattern Recognition and Applications - Distributed and Parallel Applications - User Interfaces,Visualization and Modeling - Mobile, Ad Hoc and Sensor Network Management - Web Services Architecture, Modeling and Design - Quality of Service, Scalability and Performance - Self-Organizing Networks and Networked Systems - Data Management in Mobile Peer-to-Peer Networks - Data Stream Processing in Mobile/Sensor Networks - Indexing and Query Processing for Moving Objects - User Interfaces and Usability Issues form Mobile Applications - Sensor Networks and Social Sensing - Embedded Systems and Software - Information Propagation on Social Networks - Resource and Knowledge Discovery Using Social Networks - Computer Crime Prevention and Detection - Confidentiality Protection - Critical Infrastructure Management - Critical Computing and Storage - Cryptography and Data Protection Researchers are encouraged to submit their work electronically. Submitted paper should not exceed 15 pages, including illustrations. Papers should be submitted electronically. All papers will be fully refereed by a minimum of two specialized referees. Before final acceptance, all referees comments must be considered. Important Dates Submission Deadline : March 5, 2011 Notification of Acceptance : April 5, 2011 Camera Ready Submission : May 5, 2011 Registration : May 5, 2011 Conference Dates : Aug. 3-5, 2011 - Computer Science and Internet Sun, 05 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,543/Itemid,26/ Check-in Asia is the passenger and baggage processing forum for airlines, airports and other travel industry stakeholders across the Asia Pacific region to debate how airport facilities should be developed to accommodate new check-in process and technology to improving the whole passenger experience. Check in Asia technology conference will be covering industry technologies such as CUPPS, Mobile Phone Check-in, Web-based Check-in, Biometric Check-in, passenger bag drop and NFC (Near Field Communications), etc. - Engineering and Technology Fri, 03 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,542/Itemid,26/ ATC Global is the world’s premier meeting place for the international Air Traffic Management community. The potential to expand business contacts and meet face to face with global industry colleagues, customers & suppliers is immense, with almost 5,000 industry professionals from 96 countries attending across 3 days. The 21st annual ATC Global Exhibition & Conference will take place 8 – 11 March 2011. The event which comprises a three day exhibition and two day conference and over 30 free to attend seminars, has the full backing from a range of influential organisations such as CANSO & Eurocontrol. For more information go to www.atcevents.com - Engineering and Technology Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,541/Itemid,26/ The EFV is the federation of national premanufactured building associations in Europe. Today the federation consists of the eight national members Austria, Bulgaria, Germany, Great Britain, Hungary, Ireland, Sweden and Switzerland. This year Bulgaria and Bulgarian Association of Premanufactured Building have the honour to be a host to EFV Annual Meeting. The main topics will be: - education; - earth quake safety; - fire resistance; - eurocodes; - sustainability. For more information: http://cim.bg/index.php/en/view/organizing-annual-meeting-EFV - Engineering and Technology Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,540/Itemid,26/ The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical studies will be required. You will learn of possible changes in the de novo process that could streamline the clearance process. There will be new definitions of "Substantial Equivalence" and "intended Use" will be redefined and "Indications for Use" eliminated The FDA will likely increase the requirements for the Summary of Safety and Effectiveness and require a summary of all scientific information known or that should be reasonably known to the submitter regarding the safety and/or effectiveness of the device under review. 510(k) submitters would have to provide photographs and design schematics along with detailed device descriptions, which would be available to the public on a revamped 510(k) database. In an attempt to keep up with the rapid pace of innovation in the medical device industry, the FDA plans to issue "Notice to Industry" letters to alert industry to changes in regulatory expectations by FDA for a particular group of devices, plus much more! Why you should attend: Anyone involved in preparation of 510(k)s or has products with 510(k) clearance should be concerned about the wide-ranging changes proposed by the FDA in the way 510(k)s are reviewed and regulated. While it will take some time for the FDA to finalize its regulations, some changes could be implemented in weeks or months. Therefore, it is prudent to get an overview of the type of changes being considered and the potential impact on your company and products. Comments are being accepted by the FDA now for a limited time. Areas Covered In the Seminar: * How the de novo classification process may be streamlined to permit lower-risk novel devices to reach the market faster * What changes are being considered be made to better train reviewers. * How FDA proposes to use outside experts and the web to tap into outside sources of knowledge. * Why FDA feels that it needs a class Ilb designation for those class II devices for which clinical and/or manufacturing information would be required. * How FDA would use a "Notice to industry" to communicate changes in regulatory expectations for groups of devices. * How changes in definitions of key terms in the FDA 510(k) review process, such as "Intended Use" and "Indications for Use" could impact the process. * Understand how FDA's proposed Center Science Council would promote more consistent, science-based reviews. * Why FDA wants to vastly expand the Summary of Safety and Effectiveness requirement to require inclusion of all scientific information reasonaly known to the submitter regarding the safety and/or effectiveness of the device that is the subject of the 510(k). * How an enhanced FDA database could save industry time and effort in locating information for the 510(k) submission. * Why FDA may prohibit use of a particular predicate device * When FDA would consider rescinding a 510(k) Who will benefit: * Regulatory Affairs Departments in medical device companies * Attorneys * Regulatory Consultants * Management - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,539/Itemid,26/ This webinar will describe European PV requirements, including compliance with applicable laws, regulations and guidance. In addition, attendees will learn how to compare the company's PV operations to applicable best practices in Europe. Why should you attend: Large and small pharmaceutical companies face an increasingly complex set of international regulations in their commitment to patient safety and Good Pharmacovigilance Practices. The regulatory framework in Europe presents complex challenges to meeting international requirements effectively. Areas Covered in the Session: * International Conference on Harmonization (ICH) * Regulatory Framework * European Medicines Evaluation Agency (EMEA) * Eudravigilance * Electronic submission of ICSRs * EVWEB * EUDRA CT Database * EU clinical trials directive * SUSARs * Periodic reporting * Clinical trial safety reporting * UK clinical trial regulations * Eudralex Volume 10 * Eudralex Volume 9A * Typical Clinical Safety Process Model * Best Practice Approach to Clinical Safety * Achieving Best Practices through the Pharmacovigilance Audit * Required Company Documentation * Clinical Safety Case Study * Pharmacovigilance Risk Profile * Pharmacovigilance Concepts * Example of an Effective Supporting Information Architecture * Example of How Signaling Supports Good Pharmacovigilance Practice * Signaling Fundamentals * The Pharmacovigilance Audit Who Will Benefit: * Clinical Safety/Pharmacovigilance * Regulatory Affairs * Quality management * Clinical research & development - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,538/Itemid,26/ The new requirements of the HITECH Act have a significant impact on the privacy and security of health information. This webinar will cover the changes required by the HITECH Act and the actions that needed to taken regarding breach notification, business associate contracts, training of staff and security of PHI for business associates. We will also discuss the best practices for data compliance given the impacts on your IT department. Why Should You Attend: The HITECH Act was one of dozens of provisions tucked into the economic stimulus package, known as the American Recovery and Reinvestment Act, in February 2009. The Act includes beefed-up security provisions in tandem with incentive funds from Medicare and Medicaid to help pay for adoption of electronic health records at hospitals and physician group practices. The intent is to help ensure that as more information is digitized it will remain secure. Enforcement of perhaps the most significant security provision of HITECH, the security breach notification rule, kicked in earlier this year. The HITECH Act has accelerated health IT efforts because of the potential bonuses for early compliance and future penalties for not complying with the new regulations. Is your Company on the road to compliance? Areas Covered in the Session: * Overview of HITECH Act * Review the changes that HITECH brings to HIPAA * HITECH Act's Breach Notification Requirements * Restrictions on Disclosures * Accounting of Disclosures * Prohibition on Sale of EHR * Restrictions on Marketing * Impact on Business Associates * Increased Penalties and Enforcement * Practical IT Impacts * Data compliance best practices and solutions Who Will Benefit: * Chief Information Officers * Business and IT Management * Information Technology Auditors * Compliance Officers * Quality Assurance - Ethics Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,537/Itemid,26/ This one-of-kind webinar is intended to provide you with practical guidelines on applying SLA concepts to your organization's GRC program. Organizations that have SLAs for GRC reap these benefits: * Ongoing improvements in their ability to identify, assess and prioritize risks * facilitates business owners involvement in risk management and GRC programs that affect them * Better communication on risks to stakeholders * Measurement criteria on GRC actions and a basis for ongoing improvement What You will Learn from the Webinar: * Receive a clear picture of the current view of GRC * Obtain a clear knowledge of SLA concepts and how they relate to the enterprise-wide view of Service Level management (SLM) and its associated Service Level Objectives (SLOs) * View an illustration of SLAs as applied to a facet of GRC in an enterprise * Obtain recommendations to get your GRC SLA program developed and implemented Course Outline: * Background - What is GRC and SLAs - Present deficiencies in the development of GRC programs * SLAs as a mechanism to align GRC service objectives with business objectives. * How SLAs help define and pinpoint accountability for complying with GRC provisions. * How to Develop Effective SLAs for GRC activities – Using risk analysis thinking in SLA development * Illustration of an SLA for a facet of GRC * Guidelines for Developing effectives SLAs for GRC * Question and Answer period Who Will Benefit: * CTOs (Chief Technology Officers), Chief Compliance Officers (CCOs), Chief Risk Officers (CROs) * CIOs, Information Technology (IT) VPs, Directors, Managers, Executives * IT Specialists * Information and Data Quality and Governance Specialists * Executives of user functions/department who are responsible for developing and implementing GRC provisions * Internal and External Auditors * Vendors marketing personnel who market HGRC products * Corporate and IT Governance managers responsible for governance and compliance * Internal Control specialists * Contingency Planning and Disaster Recovery specialists * IT Service Product & Delivery Managers * Business Development Managers * Legal Department Representatives * Anyone with a need to improve the quality of their company's GRC program - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,536/Itemid,26/ Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and protocol. When conducting research on children, drug companies must ensure that ethical boundaries are observed in both the design and execution of pediatric trials. Attend this Webinar to understand the ethical, economic, regulatory and technical considerations when conducting clinical studies on children. Discussions evaluate the current issues in pediatric drug development and discuss approaches and best practices for overcoming these challenges. Areas Covered in the Session: * Compilation of various regulatory and guidance documents from the FDA and OHRP on the conduct of research involving children * Recent guidances on compliance and general considerations in the conduct of research on children * General Considerations for the Clinical Evaluation of Drugs in Infants and Children * Discuss Clinical Investigation of Medicinal Products in the Pediatric Population * Nonclinical Evaluation of Pediatric Drug Products Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including: * Pediatric Affairs * Pediatric Strategy * Pediatrics * Clinical Research * Clinical Development * Clinical Operations * Clinical Affairs * Medical Affairs * Clinical Trial Management - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,535/Itemid,26/ Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system. Areas Covered in the Session: * QSR and ISO 13485 requirements for document control * Description of typical document control system in use * Streamlined document control process * Paper-free document review * Immediate document distribution * Paper-free document management system Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include: * Executive Management * Document Control Management * Document Control Clerks * Consultants * Quality system auditors - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,534/Itemid,26/ This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk Management, due for publication at the end of 2010, this webinar is designed to provide a non-math introduction to an area and discipline that is changing rapidly, especially in the light of the risk management failures that have shattered so many personal and professional lives. Why you should attend: To avoid repeating the painful failures in risk management that occurred during the global financial crisis of 2007 to 2009 (also known as the great recession), it is essential for today's business, IT, risk, compliance, and audit managers to understand the big picture of risk management to accept that risk management goes along with every position in business, technology, accounting, and finance. This is also true for many managers in the not-for-profit and government sectors. This three hour webinar is designed to provide an introduction to financial risk management including the major frameworks and standards in use today. Areas Covered In the Seminar: After attending this session, you will be able to: PART ONE * Define risk and risk management and how to differentiate them from gambling, chance, and probability’ * Differentiate between systemic and enterprise risk * Understand what is involved in risk mitigation * Grasp the relationship among governance, risk, and compliance * Conceptualize the hierarchical relationship among laws, regulations, and standards * Explain why internal controls is essential in financial reporting * See the connections between processes, risks, and controls * Accept that the principal-agent problem is universal and without a satisfactory solution * Follow a short history of risk management * Argue that an ethical tone-at-the-top is critical at the board and executive level PART TWO Understand at a high level the major risk frameworks in use today: * COSO for internal controls that impact financial reporting * ERM/COSO II and ISO 31000/31010 for Enterprise Risk Management * COBIT, ITIL, and NIST for IT risk * XBRL to automate financial reporting * Basel II for the banking industry, and Solvency II for the insurance industry. Also list the major risk associations operating today. Who will benefit: * Risk and Compliance Managers * Accounting and Finance Managers * Internal and External Auditors * Sarbanes-Oxley Managers * Managers in all types of financial services - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,533/Itemid,26/ As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not Followed" (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported immediately. Principal investigators in clinical trials are expected to adhere to the study protocol. Instances of “Protocol Not Followed” (PNF) are not addressed in the CFR or other regulatory rules. The various terms used to describe PNF (violation, deviation, and exception) are open to different interpretations by the parties involved. Attend this Webinar to understand the proactive approach to define and manage Protocol Deviation/Violation/Exception. What is the approach to predict and prevent it. Proper documentation and reporting of PNF as they occur is helpful for investigators and study sponsors, as these data can be used to determine the need for amendments to the protocol and/or the related documents. The monitoring of the frequency and nature of PNF can also be used as a quality assurance measure for the site. A noncompliance with the study protocol should be reported as soon as it is identified. This is consistent with Good Clinical Practices (GCPs). This Webinar will also discuss the guidelines for implementation of PNF to include capturing, reporting and documentation. Areas Covered in the Session: * How to define and manage Protocol Deviation/Violation/Exception * Proactive approaches to predict and prevent clinical trial protocol violations * Industry and FDA perspectives on Protocol Deviation/Violation/Exception * Discuss the current lack of unified definition for protocol deviation/violation/ exception * Unanticipated problems * Unanticipated problems vs. adverse events * Protocol deviations, violations (major & minor), exceptions Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including: * Sponsor Senior Management * Project Managers * CRA Managers * QA/Compliance * CRAs * Project management * Investigators * Regulatory affairs - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,532/Itemid,26/ Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical. Cell line development followed by preparation of the master/working cell banks is an expensive process and needs to be done right the first time. Cell banks acceptable for early clinical trial material production have been found not to be adequate and appropriate for commercial production, causing product approval delays and rejections. Why should you attend: 'Secret', according to Merriam-Webster's dictionary, is 'something kept hidden or unexplained.' A variety of reasons why an effective Chemistry Manufacturing & Controls (CMC) regulatory strategy for biopharmaceuticals can be a secret: (1) job security, especially for regulatory affairs personnel and project managers who master the strategy; (2) the infamous proprietary defense, divulging this strategy only to those within one’s own company or group, i.e., the initiated; and (3) not being aware that an effective strategy can be at hand. Insight and practical suggestions into a common sense business approach to develop and manage an effective CMC regulatory strategy for biopharmaceuticals will be provided in a multi-part series. Part 1 discusses the critical importance of the cell banks for biopharmaceuticals. Areas Covered in the Session: * Regulatory definition of biopharmaceutical starting material * Common cell lines chosen for biopharmaceutical production * Issue of clonality * Clinical phase-dependent regulatory requirements of recombinant cell banks * Pros/cons of changing cell banks during clinical development * Issue of inadequate documentation for preparation of the master cell bank * Critical importance of an effective CMC strategy for cell banks - lessons learned from product approval delays and rejections Who will benefit:This course is designed for managers, supervisors, project planners and professional staff who develop or implement the Chemistry, Manufacturing & Controls (CMC) regulatory strategy for biopharmaceutical products. * Project Management * Regulatory Affairs * Manufacturing * Quality Assurance * Quality Control * Process Development - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,531/Itemid,26/ This course will describe how to assess and optimize pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the findings. The methodology has helped companies increase compliance at reduced cost. The scope covers all pharmacovigilance activities: case processing activities such as case intake, data entry, assessment and reporting and signaling activities such as signal detection, evaluation and risk management. Why should you attend: Cost Issues: * Blockbuster drugs coming to end of patent life * Keeping products on the market without interruption becomes more essential with reduced pipeline * Current economic environment drives cost saving efforts * Peaks and valleys in case processing workload emphasize the need to optimize expensive resources Regulatory Issues: * Increased safety regulations by global government agencies * Requirement for added safety data slows down the product approval process * FDAAA enforces more stringent requirements for monitoring post-marketing safety Public confidence issues: * Heightened public awareness of product safety * Product safety reflects company image and consumer confidence Areas Covered in the Session: The following aspects will be examined: * Identify areas that require attention - strategy, planning, execution and control of case processing and signaling * Reference processes for case processing and signaling * Identify non-value added activities, redundancies, parallel and serial operations, cost-benefit of technology * Align strategy, business process, metrics and SOPs * Outsource/offshore strategy * Identify compliance risks and inefficiencies in case intake, data entry, coding and evaluation, submissions. * Signal assessment such as analysis of company data, comparison to FDA and WHO databases, prioritizing signals, case series analysis, medical significance of confirmed signal, preparing signal assessment report, and recommendations for label update. * Use of signal triage algorithms such as disproportional reporting, positive re-challenge, rapid reporting increase, new drugs, serious reactions, and reactions of special interest. * Compliance with FDA guidance as specified in “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,” March 2005. * Timing and frequency of signal detection, triage, and data mining runs. Who Will Benefit: * Clinical Safety/Pharmacovigilance * Quality management * Clinical research & development - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,530/Itemid,26/ This training entitled "How to Survive a DEA Audi or FIND=FINE" will cover all the record-keeping and security requirements that a DEA registered pharmacy must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. Why should you attend: When DEA Diversion personnel conducts an unannounced inspection of a pharmacy to perform an audit, they generally do not inform the DEA registrant on what steps will be taken during the inspection. In some cases, the pharmacist is not aware of what information they will need until they are asked by the investigators. In so many cases, the lack of record-keeping and security requirements will lead to some type of actions from an administrative violations to a civil action that may result in the pharmacy paying thousands of dollars to settle any allegation that were uncovered by DEA personnel. This presentation will cover all the elements of a DEA inspection and all the record-keeping and security requirements that are expected during that unannounced inspection and will place you in a better situation to understand all the areas of the inspection. By following the outline, you can prepare your pharmacy for that unannounced inspection. Areas Covered in the Session: Class participants will familiarize themselves with the federal laws and regulations pertaining to the dispensing of controlled substances in the form of a prescription. The presentation will: * Discuss the types of criminal and civil actions that can be imposed by a federal prosecutor’s office on a pharmacy pertaining to the purchase, sale, transfer, dispensing, destruction and theft or loss of Schedules II through V controlled substances. * Identify the steps taken by Drug Enforcement Administration (DEA) and their Office of Diversion Control in enforcing federal laws and DEA regulations. * Discuss DEA requirements pertaining to: Biennial Inventory; Executed or Voided DEA Form 222 and Invoices; Power of Attorney; Theft and Loss; Drug Destruction; and the Storage of Prescriptions. * Review DEA requirements pertaining to the writing of a controlled substance prescription by a physician and the filling of that prescription by a pharmacy. This includes electronic prescriptions, a 90-day supply of a Schedule II drug, and prescriptions written for opioid dependency patients. * Identify DEA requirements pertaining to: Alarm Systems; Pharmacy Security; Hiring of Employees; Proper Drug Disposal; Prevention of Thefts and Losses; and other security issues. Who Will Benefit: All pharmacist and pharmacy technicians who work in retail or hospital pharmacy setting and dispense Schedules II through V controlled substances to a patient in the form of a prescription that is written by a physician for legitimate medical reasons. - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,529/Itemid,26/ The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company’s personnel every day. Are there going to be noncompliance? You bet. Are you going to correct these noncompliances? Only if you identify them. To ensure substantial compliance, your company needs an effective audit program for both internal and external processes. To have an effective audit program, your company needs an effective audit team. This session will detail the best methods or training auditors, and include the best methods for performing internal audits as well as audits of suppliers and subcontractors. Areas Covered in the Session: * Effective Methods for auditor training. * Establishment of an internal audit program. * How to perform internal audits to maximize results * Establishment of an "external" audit program. * How to perform supplier/contractor audits to improve business relationships Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since internal and external auditing are requirements across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include: * Executive/senior management * Regulatory management * QA management * Purchasing management * Quality system auditors - Ethics Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,528/Itemid,26/ Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III. Areas covered in the session: * Create and use a recall operational procedure and what should it contain * Understand what are effectiveness checks * What happens in a medical device recall * Learn why a recall is either a correction or a removal depending on where the action takes place * Understand what is required for the recall strategy as expected by FDA * Medical device recall authority and guidance * Depth of recall and using a viable, sustainable and effective strategy * Understand why the documentation and paper trail are so critical and termination of a recall * Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarming Who will benefit: This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement. The employees who will benefit include: All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the recall process from start to finish, including: * Regulatory Affairs * Clinical Affairs * Quality and Compliance * Marketing & Sales * Distributors/Authorized Representatives * Legal Counsel * Engineering/Technical Services/Operations * Consultants - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100 http://www.worldconferencecalendar.com/component/option,com_conference/page,show_ad/catid,0/adid,527/Itemid,26/ This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining ongoing compliance will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for their clinical studies. Areas Covered in the Session: * Discuss the FDA's role in Drug Development * Principles of GCP * Activities that are common to most trials * Summarize FDA GCP regulations * Recognize how GCP impacts the clinical research process * Prepare concise documents and provide * Necessary information for clinical studies compliance * Maintain ongoing compliance Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including: * Managers in Clinical Development and Project Leaders * Quality Assurance Managers and auditors * Clinical Research Associates * Clinical Operations Staff * Regulatory Compliance Associates and Managers - Health and Medicine Thu, 02 Sep 2010 00:00:00 +0100