News Article | May 11, 2017
LONDON & WILMINGTON, N.C.--(BUSINESS WIRE)--Chiltern, a leading global contract research organization, will host a complimentary Xtalks webinar, “Imaging Diagnostics and Theranostics: Meeting Clinical Development Challenges.” The live session will feature thought leaders from Chiltern speaking about the new tools that have evolved in the imaging diagnostic and theranostic space and the opportunities they provide to improve the diagnosis and treatment of cancers and other diseases. “Although challenges remain, this is an exciting time to be in clinical research,” said Sapna Hornyak, MS, MBA, executive vice president, medical device & diagnostics. “This presentation will introduce viewers to the diagnostic and theranostic agents currently under development and discuss the ways they are being implemented and utilized.” Among the key topics to be discussed are innovative tools for diagnostic imaging and treatment of cancers and other diseases, the regulatory expectations for these products, and the clinical development challenges they represent. The webinar will take place May 17 at 10 a.m. (EDT). Register at ChilternWebinar.com. To learn more about this topic or get in touch with Chiltern’s Medical Device & Diagnostics team, visit Chiltern.com or schedule a meeting at the SNMMI 2017 Annual Meeting, June 10–14, in Denver, Colorado. About Chiltern Chiltern, a global contract research organization, is a leading provider of clinical services and solutions in a variety of therapeutic areas with engagement models for biopharmaceutical and medical device industries. Chiltern’s team of more than 4,300, located across 47 countries, provides comprehensive Clinical Development, Medical & Scientific Affairs, Data & Analysis, Pharmacovigilance and Strategic Regulatory services using a collaborative approach for more efficient clinical trials. Visit Chiltern.com to learn more about how Chiltern is Designed Around You®.
News Article | May 11, 2017
— Orbis Research always aims to bring their clients the best research material and in-depth analysis of the information for any market. This new report Global Pharmacovigilance (PV) software Sales Market for 2017 aims to fulfil the needs of the clients looking for a fresh outlook towards the Global Pharmacovigilance (PV) software Sales Market, or fill in the knowledge gaps with the data available in the report. The well-presented and curated report is compiled by seasoned and professional research experts and subject matter experts in the field. The clients will find the report complete in all aspects as it covers all key components with valuable statistics and expert opinions in all regards. This report studies sales (consumption) of Pharmacovigilance Software in Global market, especially in United States, China, Europe and Japan, focuses on top players in these regions/countries, with sales, price, revenue and market share for each player in these regions, covering Get a PDF Sample of Market Report at: http://www.orbisresearch.com/contacts/request-sample/281514 Market Segment by Regions, this report splits Global into several key Regions, with sales (consumption), revenue, market share and growth rate of Pharmacovigilance Software in these regions, from 2011 to 2021 (forecast), like Split by product Types, with sales, revenue, price and gross margin, market share and growth rate of each type, can be divided into Split by applications, this report focuses on sales, market share and growth rate of Pharmacovigilance Software in each application, can be divided into Also, some key information such as the cost analysis, industrial chain, sourcing strategy, distributors, marketing strategy, and factor analysis of the Global Pharmacovigilance (PV) software Sales Market are all a part of the report. The report concludes with the customary SWOT analysis and the analysis on investment feasibility and returns. As always has been the aim at Orbis Research with every report put up, the information on offer is complete and true knowledge seekers will benefit from it. Irrespective of the interest, academic or commercial, the Global Pharmacovigilance (PV) software Sales Industry report curated and compiled by domain experts will definitely shed light on key information which the clients require. Chapter One: Pharmacovigilance (PV) software Overview 1.1 Product Overview and Scope of Pharmacovigilance (PV) software 1.2 Classification of Pharmacovigilance (PV) software 1.2.1 Adverse Event Reporting Software 1.2.2 Drug Safety Audits Software 1.2.3 Issue Tracking Software 1.2.4 Fully Integrated Software 1.3 Applications of Pharmacovigilance (PV) software 1.3.1 Pharma and Biotech Companies 1.3.2 Contract Research Organizations (CROs) 1.3.3 Business Process Outsourcing (BPO) Firms 1.3.4 Other Pharmacovigilance Service Providers 1.4 Pharmacovigilance (PV) software Market by Regions 1.4.1 USA Status and Prospect (2011-2021) 1.4.2 China Status and Prospect (2011-2021) 1.4.3 Europe Status and Prospect (2011-2021) 1.4.4 Japan Status and Prospect (2011-2021) 1.4.5 India Status and Prospect (2011-2021) 1.4.6 Southeast Asia Status and Prospect (2011-2021) 1.5 Global Market Size (Value and Volume) of Pharmacovigilance (PV) software (2011-2021) 1.5.1 Global Pharmacovigilance (PV) software Sales and Growth Rate (2011-2021) 1.5.2 Global Pharmacovigilance (PV) software Revenue and Growth Rate (2011-2021) Chapter Two: Global Pharmacovigilance (PV) software Competition by Manufacturers, Type and Application 2.1 Global Pharmacovigilance (PV) software Market Competition by Manufacturers 2.1.1 Global Pharmacovigilance (PV) software Sales and Market Share of Key Manufacturers (2011-2016) 2.1.2 Global Pharmacovigilance (PV) software Revenue and Share by Manufacturers (2011-2016) 2.2 Global Pharmacovigilance (PV) software (Volume and Value) by Type 2.2.1 Global Pharmacovigilance (PV) software Sales and Market Share by Type (2011-2016) 2.2.2 Global Pharmacovigilance (PV) software Revenue and Market Share by Type (2011-2016) 2.3 Global Pharmacovigilance (PV) software (Volume and Value) by Regions 2.3.1 Global Pharmacovigilance (PV) software Sales and Market Share by Regions (2011-2016) 2.3.2 Global Pharmacovigilance (PV) software Revenue and Market Share by Regions (2011-2016) 2.4 Global Pharmacovigilance (PV) software (Volume) by Application Chapter Three: USA Pharmacovigilance (PV) software (Volume, Value and Sales Price) 3.1 USA Pharmacovigilance (PV) software Sales and Value (2011-2016) 3.1.1 USA Pharmacovigilance (PV) software Sales and Growth Rate (2011-2016) 3.1.2 USA Pharmacovigilance (PV) software Revenue and Growth Rate (2011-2016) 3.1.3 USA Pharmacovigilance (PV) software Sales Price Trend (2011-2016) 3.2 USA Pharmacovigilance (PV) software Sales and Market Share by Manufacturers 3.3 USA Pharmacovigilance (PV) software Sales and Market Share by Type 3.4 USA Pharmacovigilance (PV) software Sales and Market Share by Applications About Us: Orbis Research (orbisresearch.com) is a single point aid for all your market research requirements. We have vast database of reports from the leading publishers and authors across the globe. We specialize in delivering customised reports as per the requirements of our clients. We have complete information about our publishers and hence are sure about the accuracy of the industries and verticals of their specialisation. This helps our clients to map their needs and we produce the perfect required market research study for our clients. For more information, please visit http://www.orbisresearch.com/reports/index/global-pharmacovigilance-pv-software-sales-market-2017-industry-trend-and-forecast-2022
News Article | May 21, 2017
Receive press releases from iHealthcareAnalyst, Inc.: By Email Global Pharmaceutical Products Market Research Reports, Competitive Analytics, Trends and Forecast 2017-2021 by iHealthcareAnalyst, Inc. Pharmaceutical Products Market reports include Abumin, Active Pharmaceutical Ingredients, Acute Ischemic Stroke Diagnosis and Treatment, Anti-Aging Products and Services, Antibacterial Drugs, Anxiety Disorders and Depression Treatment, Bacterial Conjunctivitis Drugs, Breast Cancer Therapeutics, Cancer Immunotherapy, Chemotherapy-Induced Nausea and Vomiting Drugs, etc. Maryland Heights, MO, May 21, 2017 --( The global pharmaceutical products market report provides market size (Revenue USD Million 2014 to 2021), market share, market trends and forecasts growth trends (CAGR%, 2017 to 2021). The global market research reports are divided by geography into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World. The global reports also provide detailed market landscape (market drivers, restraints, opportunities), market attractiveness and profitability analysis as well as profiles of major competitors in the global market which includes company overview, financial snapshot, key products, technologies and services offered, and recent developments. Browse Global Pharmaceutical Products Market Reports, Competitive Analytics, Growth Trends and Forecast 2017-2021 by iHealthcareAnalyst, Inc. at https://www.ihealthcareanalyst.com/reports/pharmaceuticals/ Table of Contents 1. Introduction 2. Executive Summary 2.1. Market Size Estimation (Revenue USD Million, 2014-2021) 2.2. Forecast Estimation (Revenue USD Million and CAGR%, 2017-2021) 3. Research Methodology 4. Market Landscape 4.1. Market Dynamics 4.1.1. Drivers 4.1.2. Barriers 4.1.3. Opportunities 4.2. Market Share Analysis 4.2.1. Companies 4.2.2. Drugs 4.3. Market Trends Analysis 4.3.1. Key success factors 4.3.2. Market Growth Rate 4.4. Market Attractiveness Analysis 4.5. Market Profitability Analysis 4.5.1. Buyer power 4.5.2. Supplier power 4.5.3. Barriers to entry 4.5.4. Threat of substitute products 4.5.5. Rivalry among firms in the industry 4.6. Distribution Channels 5. Market Segmentation 5.1. Drug Class or Drug (Brand) Type 5.2. Drug or Disorder Test 5.3. Indication Type 5.4. Drug Treatment 5.5. Mechanism of Action 5.6. Therapeutic Area or Nature of Application 5.7. End User Groups 6. Geography (Region, Country) 6.1. North America (U.S., Canada) 6.2. Latin America (Brazil, Mexico, Rest of LA) 6.3. Europe (U.K., Germany, France, Italy, Spain, Rest of EU) 6.4. Asia Pacific (Japan, China, India, Rest of APAC) 6.5. Rest of the World 7. Regulatory Overview 7.1. IND, NDA filed, FDA, EMEA Approvals 8. Pipeline Analysis (Phase 1, 2 and 3 Drugs) 8.1. Phase 3 Drugs Forecast Estimation (Approval to 2025) 8.2. Phase 1 and 2 Drugs – Qualitative Analysis 9. Company Profiles 9.1. Company Overview 9.2. Financial Snapshot (FY 2014-2016) 9.3. Product Portfolio 9.4. Business Strategies 9.5. Recent Developments 10. Recommendations 11. References To request Table of Contents and Sample Pages of these reports visit: https://www.ihealthcareanalyst.com/reports/pharmaceuticals/ About Us iHealthcareAnalyst, Inc. is a global healthcare market research and consulting company providing market analysis, and competitive intelligence services to global clients. The company publishes syndicate, custom and consulting grade healthcare reports covering animal healthcare, biotechnology, clinical diagnostics, healthcare informatics, healthcare services, medical devices, medical equipment, and pharmaceuticals. In addition to multi-client studies, we offer creative consulting services and conduct proprietary single-client assignments targeted at client’s specific business objectives, information needs, time frame and budget. Please contact us to receive a proposal for a proprietary single-client study. Contact Us iHealthcareAnalyst, Inc. 2109, Mckelvey Hill Drive Maryland Heights, MO 63043 United States Email: email@example.com Website: https://www.ihealthcareanalyst.com Maryland Heights, MO, May 21, 2017 --( PR.com )-- The published titles of Pharmaceutical Products Market reports by iHealthcareAnalyst, Inc. include Abumin, Active Pharmaceutical Ingredients, Acute Ischemic Stroke Diagnosis and Treatment, Anti-Aging Products and Services, Antibacterial Drugs, Anxiety Disorders and Depression Treatment, Bacterial Conjunctivitis Drugs, Breast Cancer Therapeutics, Cancer Immunotherapy, Chemotherapy-Induced Nausea and Vomiting Drugs, Chromatography Accessories and Consumables, Chromatography Systems, Collagen Peptide, Contraceptive Drugs and Devices, Diabetes Drugs and Devices, Dilated Cardiomyopathy Therapeutics, Drug Device Combination Products, Dyslipidemia Drugs, Epigenetics Drugs, Erectile Dysfunction Drugs, Exocrine Pancreatic Insufficiency Diagnostics, Fragment-Based Drug Discovery, Gelatin, Geriatric Medicines, Glaucoma Therapeutics, Glioblastoma Multiforme Drugs, Hemophilia Treatment, Heparin Anticoagulant, Highly Potent Active Pharmaceutical Ingredients, Hospital Pharmaceutical Drugs, Hospital-Acquired Infection Therapeutics, Hospital-Acquired Pneumonia Drugs, Hyaluronic Acid Injections, Hypertrophic Cardiomyopathy Therapeutics, Inhalation and Nasal Spray Generic Drugs, Kidney Cancer Drugs, Liver Diseases Therapeutic Drugs, Menopausal Hot Flashes Therapy, Mouth Ulcers Drugs, Multiple Sclerosis Treatment, Nanomedicine, Nonalcoholic Steatohepatitis Treatment, Non-Small Cell Lung Cancer Therapeutics, Opioid Induced Constipation Drugs, Oral Contraceptive Pills, Organ Preservation Solutions, Organ Transplant Immunosuppressant Drugs, Osteoporosis Drugs, Pain Management Therapeutic Drugs, Parenteral Nutrition, Peptide Therapeutics, Periodontal Disease Therapeutics, Pharmacovigilance, Primary Immunodeficiency Diseases, Psoriasis Treatment, Pulmonary Arterial Hypertension, Pulmonary Drugs, Radiopharmaceuticals, Short Bowel Syndrome Diagnostics and Treatment, Smoking Cessation and Nicotine De-Addiction Products, Spinal Muscular Atrophy Treatment, Thyroid Gland Disorders Treatment, Ultraviolet Germicidal Irradiation, and Veterinary Antiseptic Drugs.The global pharmaceutical products market report provides market size (Revenue USD Million 2014 to 2021), market share, market trends and forecasts growth trends (CAGR%, 2017 to 2021). The global market research reports are divided by geography into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World. The global reports also provide detailed market landscape (market drivers, restraints, opportunities), market attractiveness and profitability analysis as well as profiles of major competitors in the global market which includes company overview, financial snapshot, key products, technologies and services offered, and recent developments.Browse Global Pharmaceutical Products Market Reports, Competitive Analytics, Growth Trends and Forecast 2017-2021 by iHealthcareAnalyst, Inc. at https://www.ihealthcareanalyst.com/reports/pharmaceuticals/Table of Contents1. Introduction2. Executive Summary2.1. Market Size Estimation (Revenue USD Million, 2014-2021)2.2. Forecast Estimation (Revenue USD Million and CAGR%, 2017-2021)3. Research Methodology4. Market Landscape4.1. Market Dynamics4.1.1. Drivers4.1.2. Barriers4.1.3. Opportunities4.2. Market Share Analysis4.2.1. Companies4.2.2. Drugs4.3. Market Trends Analysis4.3.1. Key success factors4.3.2. Market Growth Rate4.4. Market Attractiveness Analysis4.5. Market Profitability Analysis4.5.1. Buyer power4.5.2. Supplier power4.5.3. Barriers to entry4.5.4. Threat of substitute products4.5.5. Rivalry among firms in the industry4.6. Distribution Channels5. Market Segmentation5.1. Drug Class or Drug (Brand) Type5.2. Drug or Disorder Test5.3. Indication Type5.4. Drug Treatment5.5. Mechanism of Action5.6. Therapeutic Area or Nature of Application5.7. End User Groups6. Geography (Region, Country)6.1. North America (U.S., Canada)6.2. Latin America (Brazil, Mexico, Rest of LA)6.3. Europe (U.K., Germany, France, Italy, Spain, Rest of EU)6.4. Asia Pacific (Japan, China, India, Rest of APAC)6.5. Rest of the World7. Regulatory Overview7.1. IND, NDA filed, FDA, EMEA Approvals8. Pipeline Analysis (Phase 1, 2 and 3 Drugs)8.1. Phase 3 Drugs Forecast Estimation (Approval to 2025)8.2. Phase 1 and 2 Drugs – Qualitative Analysis9. Company Profiles9.1. Company Overview9.2. Financial Snapshot (FY 2014-2016)9.3. Product Portfolio9.4. Business Strategies9.5. Recent Developments10. Recommendations11. ReferencesTo request Table of Contents and Sample Pages of these reports visit: https://www.ihealthcareanalyst.com/reports/pharmaceuticals/About UsiHealthcareAnalyst, Inc. is a global healthcare market research and consulting company providing market analysis, and competitive intelligence services to global clients. The company publishes syndicate, custom and consulting grade healthcare reports covering animal healthcare, biotechnology, clinical diagnostics, healthcare informatics, healthcare services, medical devices, medical equipment, and pharmaceuticals.In addition to multi-client studies, we offer creative consulting services and conduct proprietary single-client assignments targeted at client’s specific business objectives, information needs, time frame and budget. Please contact us to receive a proposal for a proprietary single-client study.Contact UsiHealthcareAnalyst, Inc.2109, Mckelvey Hill DriveMaryland Heights, MO 63043United StatesEmail: firstname.lastname@example.orgWebsite: https://www.ihealthcareanalyst.com Click here to view the list of recent Press Releases from iHealthcareAnalyst, Inc.
News Article | May 22, 2017
DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation" conference to their offering. The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule. In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities. Understand the FDA and EMEA's requirements for a risk based audit program and current interpretation. Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes: - Identify the PV activities and processes subject to PV audit - Prioritize entities for audit according to relative risk - Identify procedures/tools to monitor PV quality of third parties For more information about this conference visit http://www.researchandmarkets.com/research/6psl33/pv
News Article | May 16, 2017
Saama's Fluid Analytics™ for Life Sciences delivers proven technology, methodology and services for rapidly orchestrating and analyzing large volumes of data. Their hybrid approach blends technology acceleration with human expertise and industry-specific data assets, enabling better business outcomes with speed and specificity. Now global pharmaceutical companies can make better clinical decisions before and after a product is introduced to the market, ultimately bringing safer, more effective products to patients in less time while enabling the platform to develop, synthesize and communicate evidence needed to meet the commercialization demands for Market access, Payer and Patient value communication. Mapi and Saama are accelerating their collaborations through joint initiatives around Centralized Clinical Data Repository to accelerate the pace of clinical innovation; Automated publications and social media search for effective identification of adverse events to increase efficiency in Pharmacovigilance Operations; and Technology enabled services for Real-World Evidence generation, Health Research Analytics and Evidence Synthesis. This comprehensive solution supports data integration, standardization, classification, text mining and sentiment analysis of various industry-specific data assets including social media and provides a query engine interface that will be utilized by Mapi experts to derive key patient insights. Murali Krishnam, VP - Life Sciences Analytics Solutions, commented, "Saama's strategic partnership with Mapi will further strengthen our 20 years of creating analytics enabled business outcomes for our customers by combining our life sciences industry specific data analytics solutions and Mapi's Patient-Centered research expertise. The combined assets will embed analytics directly within processes to provide real-time information and support guided clinical decisions for our mutual customers." Saama and Mapi will both be at the 2017 ISPOR conference in Boston during May 21st to the 25th Come visit us at booth 919. About Mapi: Patients are at the heart of our research Mapi Group has over 40 years of experience supporting Life-Science companies in developing and implementing strategies for commercializing novel treatments through Strategic Regulatory Services, Pharmacovigilance, Market Access, Language Services, and gathering Real-World Evidence on Pharmaceuticals, Biologicals, and Medical Devices. Mapi Group is the premier provider of Health Research and Commercialization services to Life-Science companies enabling Market Authorization, Market Access and Market Adoption of novel therapeutics. Visit http://www.mapigroup.com for more information. Saama Technologies is the first advanced hybrid analytics company delivering actionable business insights for life sciences, and the Global 2000. We are singularly focused on driving fast, flexible, impactful business outcomes for our clients through data & analytics. Our unique "hybrid" approach integrates pre-packaged solutions and expertise across the life sciences domain, business consulting, data science, automated data management and big data technologies, blending manual and disconnected initiatives into a well-aligned roadmap facilitating the client's journey from strategy through solution implementation. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/mapi-and-saama-create-actionable-solutions-from-recent-strategic-alliance-300458345.html
News Article | April 20, 2017
DUBLIN, Apr. 20, 2017 /PRNewswire/ -- Research and Markets has announced the addition of the "Pharmacovigilance" conference to their offering. This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in...
News Article | April 18, 2017
DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Introduction to Veterinary Pharmacovigilance" conference to their offering. This course has been designed to provide basis training and a good introduction to those concerned with Veterinary Pharmacovigilance. New entrants, support staff we well as experienced personnel who require a better understanding of veterinary drug safety will benefit from the practical guidance provided. Key terminology will be explained and roles and responsibilities will be clarified. There will be plenty of time for interaction, questions and answers to enable participants to get a good understanding of this complex subject. This course will be beneficial for those new to veterinary pharmacovigilance, support staff and experienced personnel who require a better understanding of drug safety in their current role. Adverse event monitoring and drug safety officers together with regulatory affairs and personnel from registration departments will find this seminar useful. The Current Regulatory Framework and its Global Impact - Overview of European regulatory framework, including Volume IXb and implications of the proposed EU pharmacovigilance legislation - The principles of causality assessment with practical examples Minimising the Impact of Data with Errors - Format and content of the PSUR Discussion will take place throughout the two days For more information about this conference visit http://www.researchandmarkets.com/research/p3crqc/introduction_to
News Article | May 5, 2017
DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "World Pharmacovigilance and Drug Safety Software Market by Functionality - Opportunities and Forecasts, 2014 - 2022" report to their offering. There are several drivers, restraints and opportunities shaping the future of the market. Important factors including growing incidences of ADRs have played a major role in driving the pharmacovigilance and drug safety software market. Furthermore, rising adoption rate of such software by many outsourcing companies too have kept the future of the market bright. On the other hand, government entities including FDA, EMEA and others, has increased the pressure on the biotechnology and pharmaceutical brands to manufacture safe drugs. The aforesaid factor has also added to the increasing market share of the industry. However, lack of awareness about the benefits associated with the pharmacovigilance and drug safety software market has hampered its market growth. Regions such as Asia Pacific and Latin America are likely to create greater opportunities for the market. The market is segmented based on functions, delivery model, end-customers and geography. Based on function the market segments discussed in the report consists of issue tracking solution, fully integrated solution, adverse event reporting solution etc. The mode of delivery assessed in the market research report includes on -demand and on premise delivery. The major end-customers examined during the study are pharma companies, CROs, BPOs and others. Geographies promising growth includes North America, Asia Pacific, Europe and LAMEA. A closer look at the competitive landscape reveals that major IT brands are busy launching pharmacovigilance and drug safety software and generating clients in the same month itself. Prominent market players are also seen acquiring new companies or local market players to maintain their competitive edge. Other business strategies favored by the companies include constant upgradation, joint ventures and collaborations. Prominent market players discussed in the market research report are Oracle Corporation, Online Business Applications, Inc., Sparta Systems, Inc., United BioSource Corporation and others. For more information about this report visit http://www.researchandmarkets.com/research/b3297v/world
News Article | May 5, 2017
JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that data suggests that women with relapsing forms of multiple sclerosis (RMS) who were exposed to COPAXONE® 20 mg/mL daily during pregnancy are not at higher risk for congenital anomalies compared to reference rates for abnormal pregnancy outcomes reported in two large databases representing the general population. These data appeared as an “Online First” article on the Website of the International Journal of MS Care (IJMSC) and represent the largest published analysis of pregnancy pharmacovigilance data for an RMS treatment. MS is more common among women of childbearing age compared with any other age group. The average age of diagnosis is 30, and many women go on to have children after diagnosis. Approximately half of pregnancies are unintended, which means that women with MS may become pregnant unexpectedly while taking an MS treatment. None of the MS therapies are approved for use during pregnancy. “Physicians now have this data to consider as they consult with their RMS patients planning a family or already pregnant, to make individual treatment decisions,” said Patricia K. Coyle, M.D., professor and vice chair (clinical affairs) of neurology, and the director of the Multiple Sclerosis Comprehensive Care Center at the Stony Brook University Medical Center, Stony Brook, New York. The analysis published in IJMSC compared 5,025 pregnancy cases with known outcomes from the Glatiramer Acetate (GA) Pharmacovigilance Database to two other databases of healthy women, the Metropolitan Atlanta Congenital Defects Program (MACDP)1 and the European Surveillance of Congenital Anomalies (EUROCAT)2. When compared to the rate of congenital anomalies from the MACDP database, the rate for prospective pregnancies among women exposed to COPAXONE® while pregnant from the GA Pharmacovigilance Database was comparable to the general U.S. population. Similarly, the comparison between the GA Pharmacovigilance and EUROCAT data indicated that the rate of congenital anomalies is very similar to that of the general European population. “With more than 20 years of data collected on COPAXONE®, we are able to share this important analysis with physicians to consider and counsel their patients of child-bearing age,” said Rob Koremans, M.D., President and CEO, Teva Global Specialty Medicines. “We are pleased to put forward this data that may help facilitate that conversation.” The publication, “Pregnancy Outcomes from the Branded Glatiramer Acetate Pregnancy Database,” is available online at http://ijmsc.org/doi/abs/10.7224/1537-2073.2016-079. The International Journal of MS Care is the official peer-reviewed publication of the Consortium of Multiple Sclerosis Centers (CMSC). COPAXONE® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. COPAXONE® is rated as Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on offspring development. Animal reproduction studies are not always predictive of human response, therefore COPAXONE® should be used during pregnancy only if clearly needed. See additional important information at: www.CopaxonePrescribingInformation.com. For hardcopy releases, please see enclosed full prescribing information. The COPAXONE® brand is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries. Patients allergic to glatiramer acetate or mannitol should not take COPAXONE®. Some patients report a short-term reaction right after injecting COPAXONE®. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, patients should call the emergency phone number in their area. Patients should call their doctor right away if they develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, patients should not give themselves any more injections until their doctor tells them to begin again. Chest pain may occur either as part of the immediate postinjection reaction or on its own. This pain should only last a few minutes. Patients may experience more than one such episode, usually beginning at least one month after starting treatment. Patients should tell their doctor if they experience chest pain that lasts for a long time or feels very intense. A permanent indentation under the skin (lipoatrophy or, rarely, necrosis) at the injection site may occur, due to local destruction of fat tissue. Patients should follow proper injection technique and inform their doctor of any skin changes. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. These are not all of the possible side effects of COPAXONE®. For a complete list, patients should ask their doctor or pharmacist. Patients should tell their doctor about any side effects they have while taking COPAXONE®. Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the potential benefits of COPAXONE® which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. 1 Population-based tracking system for birth defects. The MACDP was established in 1967 by the Centers for Disease Control and Prevention (CDC), Emory University, and the Georgia Mental Health Institute. 2 European network of population-based registries for the epidemiologic surveillance of congenital anomalies
News Article | April 20, 2017
This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan. This three-day introductory course is aimed at personnel in research and development departments, adverse reaction monitoring units, regulatory affairs and registration departments; pharmaceutical physicians and drug safety officers. It will also be of direct benefit to all those who are involved and interested in the daily practice of pharmacovigilance. Key Topics to Be Addressed at the Pharmacovigilance Conference: - Principles of Pharmacovigilance and Data Resources - Risk Management and Risk Minimisation - Causality Assessment: Clinical Diagnosis of Adverse Events - PASS and PAES Studies - Regulatory Framework - European Post-Marketing Pharmacovigilance Regulations - Pharmacoepidemiological Studies - Evolution of PSURs, PBRERs and DSURs - Pro-active Pharmacovigilance Pre- and Post Marketing - Clinical Trial ADR reporting requirements - Risk/Benefit Assessment - Drug Surveillance in countries outside Europe - Examples of pharmacoepidemiological studies used in risk management - Introduction to Signal detection - Introduction to Risk Management plans - Practical Pharmacovigilance Workshop Agenda: Day 1 Schedule 09.00 Registration and coffee 09.30 Principles of Pharmacovigilance and Data Resources - Basic principles of monitoring drug safety - An overview of methodology - Data resources available for monitoring and evaluating drug safety - Responding to drug safety signals Risk Management and Risk Minimisation: Basic Principles - Basic principles - Proactive strategies - Principles of risk minimisation - PASS and PAES studies Causality Assessment: Clinical Diagnosis of Adverse Events - The principles of causality assessment with practical examples - Medical evaluation of individual reports of adverse events - Strategies for follow up The Current Regulatory Framework and its Global Impact - Overview of European regulatory framework, including new EU pharmacovigilance legislation - Implications for global environment - the links to ICH and CIOMs recommendations - Inspections and penalties for non-compliance - Practical applications of definitions European Post-Marketing Pharmacovigilance Regulations Overview of requirements which will include: - The role of Pharmacovigilance Risk Assessment Committee and SCOPE initiative - Quality Management Systems and the - Pharmacovigilance System Master File (PSMF) - QPPV - Expedited Reporting solicited vs spontaneous - Periodic reports and Signal Management - Risk Management Plans and Risk Minimisation - Post Authorisation Safety and Efficacy studies (PASS/PAES) - Additional Monitoring - Pharmacovigilance Inspections/audit - Public Hearings - Stakeholder involvement initiatives such as PROTECT, WEB-RADR 17.15 End of Day One and Drinks Reception Day 2 Schedule 09.30 Pro-Active Pharmacovigilance Pre-and Post Marketing - Anticipating drug safety issues in development of small molecules and biologics - What specific and non-specific safety monitoring should be done? - Handling safety signals in development - Differences between pre-marketing studies and post-marketing experience Risk/Benefit Assessment - General principles - Quantifying risk - Taking action to optimise benefit/risk - Monitoring the effectiveness of risk management measures Clinical: Trial ADR Reporting Requirements - IH E2A and general requirements - Expedited reports - EU Clinical Trials Directive and detailed guidance - US IND requirements - Development Safety Update Reports (DSURs) Pharmacoepidemiology Studies - Basic Designs, Strenghts, Weaknesses and Examples - Real world data is the King - Randomisation in the real world - Drugs and devices - its all exposure - Tracking all patients? Where are We Now with PSURs (or PBRERs) - Evolution of the PSUR, PBRER and DSUR - ICH E2C, Volume 9A, GVP Module VII and ICH E2C (R2) What do we submit now and when is it required? - Practical aspects of compiling PSURs - The link between DSURs, RMPs, PSURs, and Core Safety Information 17.00 Close of day two Day 3 Schedule 09.30 Drug Surveillance in Countries Outside Europe - US culture - NDA and IND safety reporting - Inspections - Japan culture - Post-marketing safety surveillance programmes in Japan - Pharmacovigilance in other countries Practicalities of Signal Detection - Definitions of signals - Regulatory guidances on signal detection by industry and regulators - Resources for signal detection - Quantitative v qualitative signal detection Examples of Pharmacoepidemiological Studies Used in Risk Management - Prescription event monitoring - Prospective observational cohort studies - Case control studies - Drug registries (anti-TNFs) - Pregnancy registries Practicalities of Risk Management A real world example of the development of a successful EU risk management plan - Requirements of risk management plans from an industry point of view - How to write a successful risk management plan - Reporting results of outcomes of activities in the risk management plan - Updating a risk management plan Practical Pharmacovigilance Workshop As requested by previous participants in this course, this session will comprise a practical case study with valuable hands-on experience covering: - Handling an important safety alert from regulators - Assessment of risk - Determining measures to respond to previously unidentified risks - Continuing assessmnet and communication of risk benefit 16.00 Close of day three For more information about this conference visit http://www.researchandmarkets.com/research/2scctz/pharmacovigilance Research and Markets Laura Wood, Senior Manager email@example.com For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/three-day-pharmacovigilance-course-london-united-kingdom---december-4-5-6-2017---research-and-markets-300442736.html