Pharmacovigilance and Risk Management conference will bring together major pharma and biotech manufacturers as well as the regulators to find solutions to this increasingly important issue. This event will cover topics such as effectively monitoring RMPs and best practice in their implementation; exploring global pharmacovigilance approaches and creating global risk minimization strategies; increasing public awareness of the benefit:risk ratio of medicines and ensuring physicians fully comply to the pharmacovigilance regulations; and ensuring the data exchange between companies.
This educational two-day conference, tailored to maximise the sharing of knowledge and expertise and to promote networking for professionals in this area, will ensure you effectively manage risk management with current medicines to mitigate any risks to patients.
What sort of a Narrative is the Clinical Case Report?LitSciMed .
What sort of a Narrative is the Clinical Case Report?
Brian Hurwitz
Professor of Medicine and the Arts, KCL
A talk based on: Hurwitz B Clinical Cases and Clinical Case Reports: Boundaries and Porosities. In: Morisco B, Turchetti G, Calanchi A, Castellani G.(eds) The Case and the Canon Gottingen: Vandenhoeck & Ruprecht Unipress (In Press) expected date publication Autumn 2010
Developing an effective yet transparent pharmacovigilance strategy and keeping ahead of regulatory changes can be challenging, yet the EU’s complex safety regulations and ever-increasing media attention make both functions vital.
At VIBpharma’s 5th annual Pharmacovigilance and Risk Management conference you will gain solutions to the issues you are currently facing; from the difficulties with RMP’s and how to effectively manage risk management with current medicines to mitigate any risks to patients.
What sort of a Narrative is the Clinical Case Report?LitSciMed .
What sort of a Narrative is the Clinical Case Report?
Brian Hurwitz
Professor of Medicine and the Arts, KCL
A talk based on: Hurwitz B Clinical Cases and Clinical Case Reports: Boundaries and Porosities. In: Morisco B, Turchetti G, Calanchi A, Castellani G.(eds) The Case and the Canon Gottingen: Vandenhoeck & Ruprecht Unipress (In Press) expected date publication Autumn 2010
Developing an effective yet transparent pharmacovigilance strategy and keeping ahead of regulatory changes can be challenging, yet the EU’s complex safety regulations and ever-increasing media attention make both functions vital.
At VIBpharma’s 5th annual Pharmacovigilance and Risk Management conference you will gain solutions to the issues you are currently facing; from the difficulties with RMP’s and how to effectively manage risk management with current medicines to mitigate any risks to patients.
Pharmacovigilance at the Intersection of Healthcare and Life SciencesPerficient
Pharmacovigilance at the intersection of healthcare and life sciences by Kostas Kidos, VP of Product Strategy, Pharmacovigilance, and Risk Management at Oracle Health Sciences
Pharmacovigilance Conference on Drug Safety to be held in Jan 2010 at Mumbai, Provenance Research and www.pharmacovigilance.co.in are proud media partners
Risk managements documents required for the market placement of a medical dev...PEPGRA Healthcare
• The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product.
• Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971.
• For medicinal products the risk management documents/plan is achieved by
• If more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP)
To Continue reading : https://bit.ly/3e1harA
Contact us;
website: https://bit.ly/2W1nV6r
Email: sales.cro@pepgra.com
This is the agenda and brochure for Pharma IQ's upcoming Regulatory Information Management conference on the 2nd and 3rd of March in London.
This conference is the only event of its kind to focus solely on the management of information within pharmaceutical companies, to aid regulatory submissions. The event will bring together leading professionals to focus on the regulatory aspects of data and information management.
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
History and Development of Pharmacovigilence.pdfSasikiranMarri
Pharmacovigilance, derived from the Greek words "pharmakon" (drug) and "vigilare" (to keep watch), is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It has a rich history that spans centuries, evolving in response to medical advancements, regulatory changes, and societal needs.
The roots of pharmacovigilance can be traced back to ancient civilizations where healers and physicians observed and documented the effects of various medicinal substances. However, the formalization of pharmacovigilance began in the 20th century with significant milestones shaping its development.
In the early 20th century, the introduction of potent drugs like digitalis and barbiturates highlighted the need for monitoring their safety. However, it wasn't until the thalidomide tragedy of the 1950s and 1960s, where thousands of babies were born with severe birth defects due to prenatal exposure to the drug, that pharmacovigilance gained widespread recognition. This catastrophic event underscored the importance of systematic surveillance and led to the establishment of regulatory frameworks to ensure drug safety.
The 1960s witnessed the creation of formal pharmacovigilance systems by regulatory agencies such as the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA). These systems aimed to collect, analyze, and disseminate information on adverse drug reactions (ADRs) through spontaneous reporting systems.
The thalidomide tragedy also spurred the development of pharmacovigilance legislation worldwide. In 1961, the Kefauver-Harris Amendments in the United States mandated pre-market approval of drugs, rigorous testing, and post-marketing surveillance. Similar regulatory measures were adopted globally, emphasizing the importance of continuous monitoring of drugs throughout their lifecycle.
The 1970s and 1980s saw further advancements in pharmacovigilance methodologies and infrastructure. The WHO established the International Drug Monitoring Program (IDMP) in 1968, facilitating international collaboration in ADR reporting and analysis. Additionally, technological innovations, such as computerized databases and signal detection algorithms, enhanced the efficiency and accuracy of pharmacovigilance activities.
The 1990s marked a period of globalization and harmonization in pharmacovigilance. The International Conference on Harmonization (ICH) developed guidelines to standardize pharmacovigilance practices across regions, promoting consistency in data collection, analysis, and reporting. Furthermore, the emergence of the internet facilitated direct patient reporting of ADRs, empowering individuals to contribute to drug safety surveillance.
In the 21st century, pharmacovigilance has continued to evolve in response to emerging challenges and opportunities. The proliferation of biological therapies, personalized medicine, and pharmacogenomics has ne
A Risk Management Plan (RMP) is a documented plan that describes the risks (adverse drug reactions and potential adverse reactions) associated with the use of a drug and how they are being handled (warning on drug label or on packet inserts of possible side effects which if observed should cause the patient to inform/see his physician and/or pharmacist and/or the manufacturer of the drug)
At the time of authorization, information on the safety of a
medicine is relatively limited. This is due to the limitations
of clinical trials, including:
relatively small numbers of subjects in clinical trials compared with the intended treatment population
restricted population in terms of age, gender or ethnicity
New Build Europe 2010 will provide a platform for you to discover upcoming technologies and effectively shape your project development/management strategies.
The efficiency and profitability of coal and gas power plants is a major issue at the minute, with Utilities actively scrutinising these in their new build plans. Plus the challenges of effective operation is beginning to be a key focus, with the procurement of quality products and scheduling coming to the fore.
This conference will fully cover these areas and show you how they affect your business strategy. It will also focus on clarifying investment and lifespan issues particularly with coal plants and show how to integrate fossil and renewable energy in the long-term.
Revenue Assurance, Fraud Reduction and Cost Managment in Telecoms ConferenceArena International
Revenue Assurance, Fraud Reduction and Cost Management in Telecoms 2010 offers practical and effective strategies you can implement in your business to optimise revenue assurance and control costs. Building on the feedback from our successful 2009 event, the 2010 conference features more case studies from operators, VMNOs and ISPs than ever before, and a new focus on combating telecoms fraud.
Held on the 11 and 12 May 2010 in London is the biggest and most eagerly anticipated conference in the EMEA, and will bring together key industry experts to provide answers to current topical questions. From coping with the global economic recession and effectively controlling roaming revenues to limiting bad debt, this conference will provide insight on how to solve the critical issues that you face in the industry today.
Pharmacovigilance at the Intersection of Healthcare and Life SciencesPerficient
Pharmacovigilance at the intersection of healthcare and life sciences by Kostas Kidos, VP of Product Strategy, Pharmacovigilance, and Risk Management at Oracle Health Sciences
Pharmacovigilance Conference on Drug Safety to be held in Jan 2010 at Mumbai, Provenance Research and www.pharmacovigilance.co.in are proud media partners
Risk managements documents required for the market placement of a medical dev...PEPGRA Healthcare
• The necessity of the risk management plan (RMP) has been studied before the launch of the medical device and medicinal product.
• Risk management documents/plan for medical device is done and verified through FDA QS regulations and ISO 14971.
• For medicinal products the risk management documents/plan is achieved by
• If more than one medicinal product is studied, article 14(2) of Regulation (EC) No 1394/2007 provides a layout for RMP for such advanced therapy medicinal products (ATMP)
To Continue reading : https://bit.ly/3e1harA
Contact us;
website: https://bit.ly/2W1nV6r
Email: sales.cro@pepgra.com
This is the agenda and brochure for Pharma IQ's upcoming Regulatory Information Management conference on the 2nd and 3rd of March in London.
This conference is the only event of its kind to focus solely on the management of information within pharmaceutical companies, to aid regulatory submissions. The event will bring together leading professionals to focus on the regulatory aspects of data and information management.
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
History and Development of Pharmacovigilence.pdfSasikiranMarri
Pharmacovigilance, derived from the Greek words "pharmakon" (drug) and "vigilare" (to keep watch), is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It has a rich history that spans centuries, evolving in response to medical advancements, regulatory changes, and societal needs.
The roots of pharmacovigilance can be traced back to ancient civilizations where healers and physicians observed and documented the effects of various medicinal substances. However, the formalization of pharmacovigilance began in the 20th century with significant milestones shaping its development.
In the early 20th century, the introduction of potent drugs like digitalis and barbiturates highlighted the need for monitoring their safety. However, it wasn't until the thalidomide tragedy of the 1950s and 1960s, where thousands of babies were born with severe birth defects due to prenatal exposure to the drug, that pharmacovigilance gained widespread recognition. This catastrophic event underscored the importance of systematic surveillance and led to the establishment of regulatory frameworks to ensure drug safety.
The 1960s witnessed the creation of formal pharmacovigilance systems by regulatory agencies such as the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA). These systems aimed to collect, analyze, and disseminate information on adverse drug reactions (ADRs) through spontaneous reporting systems.
The thalidomide tragedy also spurred the development of pharmacovigilance legislation worldwide. In 1961, the Kefauver-Harris Amendments in the United States mandated pre-market approval of drugs, rigorous testing, and post-marketing surveillance. Similar regulatory measures were adopted globally, emphasizing the importance of continuous monitoring of drugs throughout their lifecycle.
The 1970s and 1980s saw further advancements in pharmacovigilance methodologies and infrastructure. The WHO established the International Drug Monitoring Program (IDMP) in 1968, facilitating international collaboration in ADR reporting and analysis. Additionally, technological innovations, such as computerized databases and signal detection algorithms, enhanced the efficiency and accuracy of pharmacovigilance activities.
The 1990s marked a period of globalization and harmonization in pharmacovigilance. The International Conference on Harmonization (ICH) developed guidelines to standardize pharmacovigilance practices across regions, promoting consistency in data collection, analysis, and reporting. Furthermore, the emergence of the internet facilitated direct patient reporting of ADRs, empowering individuals to contribute to drug safety surveillance.
In the 21st century, pharmacovigilance has continued to evolve in response to emerging challenges and opportunities. The proliferation of biological therapies, personalized medicine, and pharmacogenomics has ne
A Risk Management Plan (RMP) is a documented plan that describes the risks (adverse drug reactions and potential adverse reactions) associated with the use of a drug and how they are being handled (warning on drug label or on packet inserts of possible side effects which if observed should cause the patient to inform/see his physician and/or pharmacist and/or the manufacturer of the drug)
At the time of authorization, information on the safety of a
medicine is relatively limited. This is due to the limitations
of clinical trials, including:
relatively small numbers of subjects in clinical trials compared with the intended treatment population
restricted population in terms of age, gender or ethnicity
Similar to Pharmacovigilance and Risk Management (20)
New Build Europe 2010 will provide a platform for you to discover upcoming technologies and effectively shape your project development/management strategies.
The efficiency and profitability of coal and gas power plants is a major issue at the minute, with Utilities actively scrutinising these in their new build plans. Plus the challenges of effective operation is beginning to be a key focus, with the procurement of quality products and scheduling coming to the fore.
This conference will fully cover these areas and show you how they affect your business strategy. It will also focus on clarifying investment and lifespan issues particularly with coal plants and show how to integrate fossil and renewable energy in the long-term.
Revenue Assurance, Fraud Reduction and Cost Managment in Telecoms ConferenceArena International
Revenue Assurance, Fraud Reduction and Cost Management in Telecoms 2010 offers practical and effective strategies you can implement in your business to optimise revenue assurance and control costs. Building on the feedback from our successful 2009 event, the 2010 conference features more case studies from operators, VMNOs and ISPs than ever before, and a new focus on combating telecoms fraud.
Held on the 11 and 12 May 2010 in London is the biggest and most eagerly anticipated conference in the EMEA, and will bring together key industry experts to provide answers to current topical questions. From coping with the global economic recession and effectively controlling roaming revenues to limiting bad debt, this conference will provide insight on how to solve the critical issues that you face in the industry today.
The Oil & Gas Technology Forum Drilling Day event, located in London, will provide a platform for you to hear brand new caste studies on how the oil industry can work together to enhance profits, learn valuable strategies from top-level speakers on maximising resources as well as unlimited access to network with peers and leading experts.
Network and listen to leading experts such as Tue Hassenkam, Associate Professor, NanoGeoScience, UNIVERSITY OF COPHENHAGEN, John Corben, Senior Technical Advisor, IEA, Giovanni Botto, R&D Manager Drilling, ENI SPA and more!
Make sure you register now – the first 5 registrations get automatic places at the invite-only Oil & Gas Technology Forum on 26th & 27th March
VIBpharma is delighted to announce the 3rd Annual Competitive Intelligence in Pharma USA conference, April 13-14, 2010 in Philadelphia. CI USA continues our 12 year global series which has seen some of the largest gathering of Competitive Intelligence professionals from the pharma and biotech industries. Register now to reserve your place!
Now in its 20th year the industry renowned PLIM & PLEX conference makes a welcome return to Europe. This leading industry event, developed with industry experts and in association with Nuclear Engineering International and Modern Power Systems, will bring together a series of international case studies focusing on the development of an efficient plant life management strategy and an effective approach to licence extension
With the leading nuclear experts, PLIM specialists, consultants and technology providers this is an event not to be missed with unparalleled networking and discussion opportunities.
Our 2nd Annual Pharma Packaging & Labeling Conference brings together very senior industry experts from the leading pharma companies, from multinationals to innovative biotechs, to really drill down strategy options for both packaging and labeling that will be affordable to implement, ensure regulatory compliance and help to drive profitability.
VIBpharma’s Clinical Trials in Emerging Markets conference will bring together pharma and biotech companies to share solutions to strategic and operational challenges in setting up and conducting studies in new territories. Attendees will hear from experienced professionals who will share their knowledge on making the most of the opportunities and benefits of conducting trials in emerging markets. Attend this practical, insightful and solution led event to generate new cost and time saving ideas for your clinical trials.
VIBpharma’s Clinical Trial Supply conference brings together senior representatives from pharma and biotech manufacturers to discuss key issues through a series of high caliber presentations and interactive roundtable discussions led by industry experts. The topics being addressed will also include innovative drug mobility and labelling strategies, getting the most out of your IVRS, ensuring compliance across Europe, best practice approaches for temperature controlled transportation.
Join us in London in February to discover practical approaches for ensuring a cost-efficient clinical supply chain.
Join us for this respected and senior-level conference taking place in London on Tuesday 9 and Wednesday 10 March 2010, to network with your peers and uncover tried-and-tested solutions to these and other critical issues you face.
With country case studies and presentations from industry figureheads involved in new nuclear build and construction, can you afford to miss out?
Arena Internationals’ Operations & Maintenance Strategies for Coal & Gas Power Stations being held on 18th and 19th March in London, UK, aims to establish solutions to key issues such as:
The impact of future government legislation on your O&M strategies
Executing the best O&M strategies to ensure your plant’s life is extended
The impact of carbon capture on your power station - case study on a CCS pilot plant
How to make your plant more flexible by understanding how to implement successful optimisation techniques
Through case study driven presentations from leading energy operators and a series of informative panel debates, this event will provide you with best practice solutions to help you comply with existing and upcoming challenges in the market.
If you’re involved in small hydro, you need to be at Small Hydro. Why?
Over 14 case studies from leading IPPs, utilities and developers – find out how to overcome the challenges they faced and get first-hand experience of how to meet obstacles in your own operations
12 countries represented - whether your small hydro interest is multi-national or community focussed, uncover new opportunities and learn about new techniques from experts around the world
A special focus on licensing, regulations and permitting – with so many complex processes affecting the licensing of your project, make sure you are up to date with changing regulation and expectations
Funding Masterclass – Make sure you’re positioned to benefit from upcoming opportunities and avoid funding pitfalls at this dedicated session
An overview of some of the newest and most exciting technologies in the industry. Find out what will save and what will make you money in plant efficiency
Gain a new perspective on your challenges through input and feedback from government bodies and leading international organisations
Make the most of over 12 hours of networking, including roundtables, drinks and dinner to meet with your peers and share ideas on a one-to-one level
Following on the success of our 3rd Biosimilars conference VIBpharma is proud to announce the 4th annual Biosimilars conference taking place on Tuesday 16 and Wednesday 17 March 2010 in Brussels, Belgium.
Through a series of presentations and interactive discussions covering key issues such as current market trends, biobetters, the global regulatory environment, pricing and reimbursement strategies and biosimilars in emerging markets, participants will gain new insight and share hands-on experiences with leading companies in the pharma and biotech industry.
VIBevents’ 7th Annual Cold Chain Storage and Distribution conference will bring together key manufacturers and industry experts to discuss these amongst other core issues. From understanding key transport, packaging, validation and qualification methods to optimising strategies for storing biotech and pharma products, this event will provide a platform to debate best practice approaches.
Once again, this event will be co-located with our established Clinical Trial Supply event in order to provide you with more opportunities to interact and exchange ideas with peers from both backgrounds.
Following the success of this conference series, Arena International’s 6th Annual Fire Protection of Rolling Stock conference will be held on Tuesday 24th – Wednesday 25th March 2010 in London. The event will establish strategic solutions and highlight new technologies to enhance fire protection of railway vehicles. Through a series of best practice presentations and case studies, this event will provide you with insight into railway operator and rolling stock manufacturer approaches as well as presentations from regulatory authorities to current and upcoming fire safety issues.
Global Asset Security: Oil and Gas gives you the opportunity to hear from security experts with specific expertise in security threats around the world and across the US. You will have the chance to share knowledge and experience on common or industry challenges such as ensuring the safety of your personnel, and maximizing the robustness of your product supply chain in order to reduce your financial and physical vulnerability.
Attendance at Global Asset Security: Oil and Gas 2010 is essential for anyone involved with developing security strategy or running the security program either in the US or abroad
At a strategic level, The event will address the increasing need for security to be more effectively and efficiently integrated into overall business strategy, and how you can effect such integration in your business. How can you minimize the effect of budget constraints on your security programs? To what extent is your intellectual property safe and how can you improve your defense against financially damaging security breaches?
Key benefits of attending Global Asset Security: Oil and Gas 2010
Understand the business models and security trends that are driving the industry
Discover how TWIC and CFATS regulations can be efficiently assimilated into your business plan in order to ensure compliance and maximize effectiveness
Evaluate the changes in criminal strategy and uncover the true costs (and benefits) of implementing solutions
Reduce your loses and improve your safety record by creating the best possible offshore security program
Get the competitive edge- learn to maximize ROI from your security investments
Get critical insights into the real changes in global security in the regions where you have an interest
The market for mobile banking and other mobile financial services is growing at an ever increasing rate, with customer adoption in the US set to grow to 56 million users in the next few years. Institutions that have led the way are already seeing customer loyalty, return per customer and customer acquisition benefits.
The question now is not if I should enter this market, but how do I compete in the mobile banking space?
Mobile Financial Service Congress, 2-3 December, Miami, Florida, will provide critical insights to overcome technical and budgetary challenges, and winning strategies for fully exploiting the mobile channel.
With both the Rail and the Road authorities imposing increased tunnel safety standards, those working in the industry must invest to meet mandatory requirements or risk being excluded. The upside comes from the still very lucrative gain that is available in the industry and the high potential return for forward looking companies that can excel in this area.
With guidance needed on how to accomplish compliance by means of maximum efficiency and minimal expenditure, the first annual Fire Protection and Safety in Tunnels conference is being held in Paris, 17-18 Nov 09 to help you meet industry safety standards, optimise your risk management and achieve safety excellence.
The Clinical Trial in Oncology event on 1-2 December 2009 in Munich will show you how to utilise target approaches to optimize your clinical research and enhance your patient enrolment, data quality and much more.
The overall goal of your data management model is to capture quality data in a timely and cost efficient method. However, instituting and complying with upcoming CDISC standards can be challenging especially with existing trials.
To prepare you for these regulation changes, VIBpharma has brought together industry experts to answer all of your questions and provide you with solutions to ensuring a seamless integration of the CDISC standards.
Renewable energies are an extremely under used resource throughout Europe, a major reason for this is because, there is currently nowhere for this perishable power to be stored. However, Arena International’s Energy Storage Solutions conference will bring together the key players, latest research and leading solution providers to enable you to overcome the critical challenges of the European energy storage market.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
Follow us on: Pinterest
Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Basavarajeeyam - Ayurvedic heritage book of Andhra pradesh
Pharmacovigilance and Risk Management
1. VIBpharma Benef
it
to-pee from a pee
round r interacti r-
5th Annual tab ve
to add le morning
Pharmacovigilance obsta ress key
find th cles and
releva e solutio
nt to ns
and Risk Management
proce everyday
dures
Optimal PV and RM strategy and implementation to
ensure regulatory compliance and maximise drug safety
Tuesday 1 and Wednesday 2 December 2009, Brussels, Belgium
DISTINguISHED SPEAkERS INCLuDE: with 19 pharma and regulatory
Dr Thomas Verstraeten, Vice President, Head, Biologicals Clinical representatives on the programme,
Safety and Pharmacovigilance, gSk BIOLOgICALS
this event will provide invaluable
Dr Hans Joachim gamperl, Vice President, global Drug Safety and insight into key areas of Pv and rM
Pharmacovigilance QPPV, FRESENIuS BIOTECH
Craig Hartford, Executive Director, SRM/RMS Primary Care
Business unit Leader, PFIZER
3 HIgHLIgHTS!
Prof Philippe Van der Auwera, global Head of Safety Risk
Management (PDS) and Eu-QPPV, ROCHE ● Critical insights on the practical
Dr Duc Vu, Director, Marketed Bilogics, Biotechnology and Natural implementation of PV on a global,
Health Products, Marketed Health Products Directorate, HEALTH regional and country specific scale
CANADA
Doris Stenver, Chief Medical Officer, Consumer Safety Division,
● Take a global approach on PV and RM
DANISH MEDICINES AgENCy and Pharmacovigilance Working Party issues: clarify requirements form the
Delegate, EMEA uSA, Eastern Europe, Canada, Norway
Monica Rusu, Director PharmacovigilanceEELA, global and Denmark to ensure compliance in
Pharmacovigilance and Risk Management, SOLVAy
PHARMACEuTICALS gMBH
a global setting
Phil Weatherill, Director, global Pharmacovigilance, IPSEN ● Essential case studies on ensuring
Dr Maria grazia Zurlo, Vice President, Pharmacovigilance Strategy
legislative compliance and best practice
and Policy, PFIZER
Erica Velthuis, Senior Pharmacovigilance Scientist and
Epidemiologist, gENZyME EuROPE
ADDED EXTRA BONuS:
Dr Ennis Lee, Vice President and Qualified Person for
Pharmacovigilance, Pharma, Benefit Risk Management, ● With 19 pharma and regulatory
JANSSEN CILAg representatives on the programme, this
Bert Van Leeuwen, Director of global Drug Safety, ORgANON (now event offers you invaluable insight into
part of the SCHERINg-PLOugH CORPORATION) critical areas of PV and RM
REgISTER NOW: ■ Email: book@vibevents.com
■ Tel: +44 (0)20 7753 4268 ■ Fax: +44 (0) 20 7915 9773
Register online now at: www.vibpharma.com/pharmacovigilance
2. Programme day one Tuesday 1 December 2009
08:30 Registration 11:40 Highlighting successful RM strategies in a post approval
setting to maximise patient safety
09:00 Opening remarks from the Chair
● Critical assessments of RM techniques and methodologies
Dr Monica Rusu, Director Pharmacovigilance EELA,
● Deciding on the best strategy for managing product risk
global Pharmacovigilance and Risk Management,
● Highlighting successful techniques to monitor RM to ensure
SOLVAy PHARMACEuTICALS
minimal risk
View from the regulators: clarifying their ● Meeting the regulators’ expectations with robust RM policies
interpretation of key PV and RM legislation ● Case study: the most effective methods for risk mitigation
Rudi Scheerlinck, Director, global Clinical Safety and
09:10 Case study: the Danish approach to PV and RM Pharmacovigilance, uCB
● Highlighting the Danish PV action plan: reviewing major
elements and objectives to ensure regulatory compliance Effective approaches to monitoring and reporting
● Clarifying the impact of significant societal trends, such as Adverse Drug Reactions (ADRs)
the internationalisation and empowerment of the citizens,
12:10 Exploiting the latest technologies and methodologies
on work practices at national level to understand how this
will affect your RM strategy
for optimal ADR monitoring and reporting
● Positioning response to adverse events at the core of your
● Establishing the interrelation between the Danish
RM activity
● Medicines Agency and the EU organisation
● Developments from the cutting edge of the science and practice
● Evaluating the PSUR work share initiative and its effectiveness:
of ADR signal detection
outlining the current status from a regulatory point of view RM
● Evaluating the impact and effectiveness of electronic reporting
and risk minimisation: case study examples
Speaker TBC
Doris Stenver, Chief Medical Officer, Consumer Safety Division,
Danish Medicines Agency and Pharmacovigilance Working 12:40 Lunch and networking
Party Delegate, EMEA
Essential case studies: detailing specific
09:40 The Norwegian approach: implementing a PV plan challenges and proposing solutions
and risk minimisation activities at a national level
● Evaluating proposed RMPs: assessing how to increase their 13:50 Determining a robust drug safety strategy for vaccines
quality and usefulness to maximise the efficiency of drug to guarantee their excellence and therefore their
safety strategies acceptance for use in healthy people
● Highlighting lessons learned from the practical implementation ● Exploring the challenges to thoroughly analyse the benefit:risk
of activities proposed in RMPs to determine best practice evaluation and mitigate hazards
● Enhancing PV activities ● Generating guidelines to ensure that all adverse events are
● Reviewing educational materials to be used recorded consistently and accurately
● Handling of DHPCs ● Maximising adverse event information and data accuracy
Ingebjørg Buajordet, Head of Pharmacovigilance, through spontaneous reporting by minimising under-reporting
NORWEgIAN MEDICINES AgENCy ● Illuminating the importance of pharmacoepidemiology studies
to confirm the alerts identified by spontaneous reporting
10:10 Panel Session: Translating regulatory compliance into ● Reviewing mechanisms for active surveillance to generate
a practical, globally actionable PV strategy best practice
● Managing across multiple regulatory frameworks to ensure Dr Thomas Verstraeten, Vice President, Head, Biologicals Clinical
company-wide compliance Safety and Pharmacovigilance, gSk BIOLOgICALS
● Disseminating information and strategy effectively and creating
awareness throughout the organisation 14:20 Case study: identifying the challenges of PV for
● Practical guidance on implementation through and for affiliates orphan drugs in order to implement a strong risk
Doris Stenver, Chief Medical Officer, Consumer Safety Division, management strategy
Danish Medicines Agency and Pharmacovigilance Working ● Tackling the internal challenges of a small company to make the
Party Delegate, EMEA best use of limited resources
Ingebjørg Buajordet, Head of Pharmacovigilance, ● Building a robust PV system with limited resources
NORWEgIAN MEDICINES AgENCy ● Ensuring effective signal detection and RM during development
to fully assess drug safety
10:40 Morning refreshments and networking ● Developing signal detection and risk management strategies
post marketing for orphan drugs
Achieving successful, practical implementation ● The way forward…
of PV and RM processes Dr giuseppe Alvaro, Director, Drug Safety and
11:10 Evaluating successful strategies for PV in marketed Pharmacovigilance, SANTHERA PHARMACEuTICALS
products to maximise drug safety
● Highlighting the key factors in PV in order to provide thorough
Ensuring globally effective PV strategies
information on adverse reactions and overall drug safety 14:50 Highlighting the FDA’s Risk Evaluation and Mitigation
● Ensuring you meet the regulators’ expectations through clear Strategies (REMS)
results and increased transparency ● Reviewing the legislation around REMS to clarify what
● Determining best practice approaches for a successful is necessary
PV strategy ● Determining practical insights into REMS to ensure they
● Looking towards the future: the need for increasing transparency are successful
in PV and its impact on pharmaceutical companies ● Clarifying the opportunities to integrate various global risk
Dr Ennis Lee, Vice President and Qualified Person for management plans to create a global drug safety strategy
Pharmacovigilance, Pharmaceuticals, Benefit Risk Craig Hartford, Executive Director, SRMRMS Primary Care
Management, JANSSEN CILAg Business unit Leader, PFIZER
3. Programme day two
15:20 Afternoon refreshments and networking 08:30 Registration
15:50 Focus on Eastern Europe: reviewing the PV structure 09:00 Opening remarks from the Chair
and regulations to maximse drug safety Phil Weatherill, Director, global Pharmacovigilance, IPSEN
● Identifying the drug safety regulations in order to
enhance compliance 09:10 Roundtable morning sessions
● Effectively following the new legislation to maximise your Delegates will be able to attend three one-hour roundtable
PV strategies in Eastern Europe discussion groups from a selection of key topics. Each ses-
● Reviewing methods of monitoring risk mitigation sion will be chaired by an industry expert who will facilitate
strategies efficiently an exchange of opinions, essential experiences and learn-
● Assessing the challenges of PV in Eastern Europe to better ing related to a current aspect of PV and RM
understand where problems may occur
● Case study: highlighting examples of best practice to Roundtable 1
develop a comprehensive benefit:risk assessment
Exploring the most effective methods for the practical
Dr Monica Rusu, Director Pharmacovigilance EELA,
implementation of RMPs
global Pharmacovigilance and Risk Management,
SOLVAy PHARMACEuTICALS This session will look at the most effective methods
for implementing your RM strategies and the different
Risk based inspections: passing audits with tools you can use when gathering the data.
flying colours Monica Rusu, Director PV EELA, global Pharmacovigilance
16:20 Preparing for risk based inspections to meet the and Risk Management, SOLVAy PHARMACEuTICALS gMBH
regulators’ expectations Roundtable 2
● Reviewing the compliance report requested by the MHRA
(implemented in 2009) to fully understand what is required Highlighting the role of the QPPV
● Successfully deploying assessment algorithms to accurately This session will explore the role QPPV and their
interpret data crucial role in the overall PV plan and how best to
● Compiling an inspection readiness plan for affiliates in order manage risks and the scope of their role.
for them to address all the necessary pointers Dr Peter De Veene, Deputy European Qualified Person for
● Facilitating interaction between the central Pharmacovigilance, ROCHE
pharmacovigilance team and the affiliates to create a
successful company wide drug safety policy Roundtable 3
Dr ute Hoeffner, European Qualified Person for Reviewing global compliance in PV to maximise drug
Pharmacovigilance, NOVARTIS CONSuMER HEALTH
safety at a global level
Enhancing safety monitoring processes This session will explore global PV legislation and
through efficient epidemiology strategies find solutions to the challenges to meet disparate
16:50 Highlighting the importance of epidemiology in regulations. You will also assess how to move forward
PV and RM to increase safety monitoring to make this more viable in the future.
● Evaluating the advantages of epidemiology vs Bert Van Leeuwen, Director of global Drug Safety,
pharmacoepidemiology to determine how best to maximise ORgANON (now part of the Schering Plough Corporation)
safety monitoring
Exploring the need for epidemiology in clinical
Roundtable 4
●
development to increase the safety data available before Overcoming challenges when completing PSuRs to
the drug goes to market ensure all safety data is up to date
● Establishing the importance of epidemiology in post- This session will discuss the challenges surrounding
marketing safety to advance the level of scientific PSURs to clarify their writing, submission and
knowledge for a drug implementation. You will also analyse the work
● Clarifying the use of epidemiology in RM to ensure safety
sharing initiative to assess current practices and the
monitoring is maximised
Erica Velthuis, Senior Pharmacovigilance Scientist and success of the scheme.
Epidemiologist, gENZyME EuROPE Dr Agnieszka Majcher-Dann, Acting Qualified Person
for Pharmacovigilance, Consumer Healthcare,
Emphasising the role of the QPPV JOHNSON & JOHNSON
17:20 Assessing the growing importance of the QPPV in the Roundtable 5
evolving PV environment to understand their key role
Pharmacoepidemiology in RM: clarifying its role in
● Clarifying the scope of the QPPV’s role to fully realise the
increasing drug safety
pivotal part it plays
● Highlighting the challenges of the position and the legal This session will look at the significant links
responsibility to ensure that all requirements are met between pharmacoepidemiology and clinical
● Determining how the role has evolved and where it will head development, post-marketing safety and RM to
in the future to assess its likely impact on PV highlight how it can mitigate risk.
Dr Maria grazia Zurlo, Vice President, Pharmacovigilance Erica Velthuis, Senior Pharmacovigilance Scientist and
Strategy and Policy, Pfizer Epidemiologist, gENZyME EuROPE
17:50 Closing remarks from the Chair
12:30 Lunch
18:00 End of day one
4. Wednesday 2 December 2009
Focus on new regulatory initiatives ● Developing different methods of raising awareness (types of
campaigns, leaflets and advertisements etc) to assess which
13:40 Highlighting the Developmental Safety update is most affective
Report (DSuR) to assess the implications for ● Encouraging the public to report adverse reactions through
future PV reporting increased communication to minimise under reporting
● Emphasising the implications of increasing public ● Assessing PV reporting methods used by physicians and
expectation on drug safety to determine how to encourage patients to establish clear and concise approaches
users to discuss any perceived undesirable side effect with Prof Philippe Van der Auwera, global Head of Safety Risk
their doctor or pharmacist Management (PDS) and Eu-QPPV, ROCHE
● Improving communication with health professionals,
patients and the public to increase the accuracy of post RMPs: highlighting practical advice to ensure
marketing safety data there are no gaps in your strategy
● Developing different methods of raising awareness (types
16:20 Writing an effective RMP to mitigate delays in
of campaigns, leaflets and advertisements etc) to assess
which is most affective
submission timelines
● Reviewing the key elements to be included to ensure you
● Encouraging the public to report adverse reactions through
meet the regulators’ requirements
increased communication to minimise under-reporting
● Evaluating different approaches towards risk assessment in
● Assessing PV reporting methods used by physicians and
order to include the most effective in your RMP
patients to establish clear and concise approaches
● Determining the role of epidemiological studies in risk
Bert Van Leeuwen, Director of global Drug Safety,
management to use them to their full advantage in your RMP
ORgANON (now part of the Schering Plough Corporation)
● Troubleshooting: analysing areas where pitfalls are common
14:10 Reviewing the Periodic Safety update Report (PSuR) to minimise errors and timely delays in submission
Work Sharing Initiative to evaluate its effectiveness ● Working with different departments to generate all the
● Explaining the initiative introduced to minimise duplication necessary information
● Exploring the authorities’ work processes and timeframes ● Highlighting best practice examples demonstrating effective
to be able to work to their expectations implementation techniques
● Highlighting how successful the initiative is through Dr Agnieszka Majcher-Dann, Acting Qualified Person
feedback from the authorities for Pharmacovigilance, Consumer Healthcare,
● Assessing the challenges which have arisen to evaluate JOHNSON & JOHNSON
possible solutions
16:50 Case study: best practice methods to monitor and
● Looking forward: how to make the process more efficient
Dr Marina Belle, global Pharmacovigilance, unit Manager
evaluate RM to assess the effectiveness of your RMP
● Demonstrating different methodologies to monitor RM to
PSuR, SANDOZ INTERNATIONAL
assess effective approaches
14:40 Outlining the Canadian perspective in PV activities ● Reviewing the various tools available to determine best
● Reviewing the Canadian regulatory system and Health practice in your monitoring approach
Canada activities related to the PSUR, Phamacovigilance ● Establishing appropriate methods to measure the
and Risk Management Plan (PvP/RMP) in order to meet the effectiveness of your RM strategy
requirements ● Highlighting best practice methods and lessons learned
● Highlighting the PV "tool kit" to optimise quality and efficacy Phil Weatherill, Director, global Pharmacovigilance, IPSEN
while minimising the risks that may be associated with
health products approved for sale in Canada
17:20 Experiences of a small company: submitting
● Assessing experiences and challenges encountered in the a successful RMP supporting the Eu approval of
review activities of PSUR, PvP/RMP in Canada to demonstrate a therapeutic antibody
trouble areas and best practice ● The company's drug safety and the antibody's properties as
● Establishing signal detection activities using “Canada necessary background information
Vigilance database” and other international adverse drug ● A safety strategy during clinical development as an essential
reaction databases as well as information from PSURs to tool for risk evaluation
create a global drug safety outlook ● The presentation of safety data in the dossier (CTD) impacts
Dr Duc Vu, Director, Marketed Biologics, Biotechnology the RMP
and Natural Health Products, Marketed Health Products ● The establishment of the RMP requires early planning and
Directorate, HEALTH CANADA multiple input
● Lessons learned
15:20 Afternoon refreshments Dr Hans Joachim gamperl, Vice President, global Drug Safety
and Pharmacovigilance QPPV, FRESENIuS BIOTECH gMBH
key factors in today’s changing PV environment
15:50 Increasing public awareness of risk to ensure that 17:50 Closing remarks from the Chair and champagne
patients fully understand the benefit:risk analysis prize draw
of a drug hence can take an informed decision with
their prescribing physician 18:00 End of conference
● Emphasizing the implications of increasing public
expectation on drug safety to determine how to encourage
users to discuss any perceived undesirable side effect with
their doctor or pharmacist
● Improving communication with health professionals,
patients and the public to increase the accuracy of post
marketing safety data
5. Media partners About the event
Pharmaceutical Technology is Following the enormous success of our Pharmacovigilance and
used daily as a means of creating Risk Management event earlier this year, VIBpharma is proud to
partnerships and as a point of announce the dates for our fifth annual Pharmacovigilance and
reference by professionals within the pharmaceutical industry. Risk Management conference this December. The role of drug
This comprehensive resource supplies the latest news releases, safety both in drug development and postmarketingsurveillance
detailed information on industry projects, white papers, has increased enormously over recent years, especially in an
event information and a thorough breakdown of products and era where the public are much less tolerant to medical risk and
services. www.pharmaceutical-technology.com have many more ways in which to express their opinions. With
a continually changing regulatory environment it is imperative
Drug Development Technology that you are kept up to date with the latest changes to develop a
is a procurement and reference robust Pharmacovigilance strategy in which there are no gaps.
resource providing a one-stop-
shop for professionals and decision makers within the VIBpharma’s Pharmacovigilance and Risk Management
drug development and medicines industry. We provide a conference will bring together major pharma and biotech
comprehensive breakdown of drug development contractors manufacturers as well as the regulators to find solutions to
and suppliers, up-to-date news and press releases, white this increasingly important issue. This event will cover topics
papers and detailed information on current industry projects such as effectively monitoring RMPs and best practice in
and trends. Our recruitment area provides career information their implementation; exploring global Pharmacovigilance
and the latest job vacancies in the field. approaches and creating global risk minimization strategies;
www.drugdevelopment-technology.com increasing public awareness of the benefit:risk ratio of
medicines and ensuring physicians fully comply to the
The Business Review websites are Pharmacovigilance regulations; and ensuring the data exchange
your number one stop for all the
between companies.
latest news, comment and industry information. Each Business
Review website offers content that is produced by a dedicated
This educational two-day conference, tailored to maximise the
team of journalists and global industry experts. In addition to
sharing of knowledge and expertise and to promote networking
the free content made available on the sites an intelligence
for professionals in this area, will ensure you effectively
store will provide you with premium market analysis reports
manage Risk Management with current medicines to mitigate
from the leading global suppliers of market research and
any risks to patients.
industry analysis.
Pharmaceutical Business Review is
the world's leading pharma website,
being used by over 100,000 visitors TESTIMONIALS – Here is what previous delegates
every month. For further information have said about previous PV conferences
contact jsharp@industryreview.com
“Very useful with a lot of hot topics”
World Pharmaceutical Frontiers Patient Safety Manager, ASTRAZENECA
The pharmaceutical industry is
World Pharmaceutical Frontiers www.worldpharmaceuticals.net
“Very good to meet people; fruitful discussions”
changing fast. There are more regulations, technologies, CQA PV Specialist, NOVARTIS
faster product launches and shorter product life cycles than
ever before. World Pharmaceuticals frontiers is, and will “It was very useful and lively meeting and I have the
continue to be, at the forefront of these changes, so visit us opportunity to interact with many other colleagues
at www.worldpharmaceuticals.net and stay up to date with not only from the pharma industry but also the
all latest developments regulators. We shared a lot of experience and I
learned a lot!”
Director of PV, SOLVAy PHARMA
Who should attend:
“A good choice of speakers and enough time devoted
Heads, Directors and Managers from pharma and biotech
to discussion”
manufacturers working in the following areas:
Head of Drug Safety, BOEHRINgER INgELHEIM
● Pharmacovigilance
“Globally a good overview with current practices
● Qualified Person (QP) for PV
and issues in PV. A good opportunity to exchange
● Drug Safety
experiences with colleagues”
● Benefit-Risk Management Senior Director, Safety and Compliance, IPSEN
● Medical INNOVATIONS
● Risk Management
“Good interaction and variety of speakers. Overall I
● Clinical Operations
enjoyed the experience and exchanged best practice
● Clinical Safety
with others”
● Epidemiology
PV Manager, SCHERINg PLOugH
● Product Safety and Quality Management
● Regulatory Affairs “Very high quality speakers and the roundtable
discussion groups allowed a good exchange of
experiences”
Drug Safety Specialist, MERCk SERONO
“Very good, well organised conference”
Do you wish to exhibit your products Director, Marketed Biologicals, HEALTH CANADA
and services at this exclusive event? “Highly professional speakers and audience, very
knowledgeable and open. Pleasant overall”
Contact details: Paul Adams, Drug Safety Solution Manager, QuINTILES
pauladams@arena-international.com, +44 (0) 20 7753 4259
6. Booking Form
Pharmacovigilance and Risk Management, Tuesday 1 and Wednesday 2 December 2009, Brussels, Belgium
Yes, i would like to register for the event: Before Before After ■ Register online at
6.10.2009 3.11.2009 3.11.2009
www.vibpharma.com/pharmacovigilance
i am a Pharma Manufacturer/biotech representative and i would like to register for the event:
I would like to attend the 2-day conference + the interactive €2590 €2730 €2940 ■ Email us at
CD-ROM (saving €70) † events@arena-international.com
I would like to attend the two day conference only €1960 + VAT @ €2100 + VAT @ €2310 + VAT @ ■ Tel +44 (0)20 7753 4268
21% = €2371.60 21% = €2541 21% = €2795.10
■ Fax +44 (0)20 7915 9773
i am an Academic representative and i would like to register for the event:
I would like to attend the 2-day conference + the interactive €1680 €1820 €2030 Venue Details
CD-ROM (saving €70) † The two day conference will take place on Tuesday
€1050 + VAT @ €1190 + VAT @ €1400 + VAT @ 1 and Wednesday 2 Dec 2009, in Brussels, Belgium
I would like to attend the two day conference only 21% = €1270.50 21% = €1439.90 21% = €1694
at the Sheraton Brussels Airport Hotel For further
fees for all other attendees information contact our Operations department on
+44 (o) 207 753 4201.
I would like the VIP Package attendees package to €3590 €3730 €3940
include the two day conference + interactive CD-ROM
Are you registered?
I would like to attend the two day conference €2960 + VAT @ €3100 + VAT @ €3310 + VAT @ You will always receive an acknowledgement of your
21% = €3581.60 21% = €3751 21% = €4005.10
booking. If you do not receive anything, please call
I cannot attend the conference but would like to receive €700 €700 €900 us on +44 (0) 20 7753 4268 to make sure we have
the interactive CD-ROM † received your booking.
† VAT where applicable
Discount code if applicable _________________________
Total Discounts are at the discretion of Arena International and are not cumulative All total fees are subject to a 2.5% service charge
Arena International Conference Delegate terms and conditions 5 General: You, your executive/s or your agents may not transfer or assign any of the rights or obligations of this
1. Scope of Agreement: These are the conditions of the contract between you, the Client (“You” and “your”) and Arena Agreement (in whole or part) without our prior consent. Any attempt to resell, assign or transfer rights without our consent
International Events Group (“Arena International Events Group”, “we”, “us” and “our”) governing your use of our will entitle us to cancel the contract without liability to you.
services, including the conference registration as set out in your booking form. This agreement constitutes the entire • This agreement is governed by and will be construed in accordance with English law and each party irrevocably
agreement between Arena International Events Group and you. All prior agreements understandings and negotiations and agrees that the courts of England will have the non-exclusive jurisdiction to deal with any disputes arising out of or in
representations (save for fraudulent misrepresentation) whether oral or in writing are cancelled in their entirety. The terms of connection with this agreement.
any other electronic communications will not form part of this agreement. • Grant of Licence: If your booking includes the CD-ROM, you warrant that you will only use the CD-ROM for your business
2 Our commitment to you: Should the Event be cancelled or the location be changed for reasons or circumstances beyond purposes and shall not, without our prior written consent, make available, copy, reproduce, transmit, disseminate, sell, licence,
our control, we reserve the right to reschedule the Event, including changing the location, upon written notice to you. Should distribute, publish, broadcast or otherwise circulate the CD-ROM (or any part of it) to any other person other than in accordance
the event fail to be rescheduled for any reason your refund shall not exceed the total charge received by us from you. with these terms and conditions.
3 Payment Terms: The Total Fees specified on the booking form are subject to an additional service charge of 2.5% • Arena International Events Group is subject to the UK Data Protection Act 1998 and is registered in the UK with the
(“Service Charge”) applied to cover administration costs, and are exclusive of VAT and any other applicable sales tax Information Commissioner to process your personal information. Our primary goal in collecting personal information from
which shall be payable in addition. you is to give you an enjoyable customised experience whilst allowing us to provide services and features that most
• Following completion and return of the booking form, full payment including Service Charge is required within five days likely meet your needs. We collect certain personal information from you, which you give to us when using our Sites
from the invoice date or prior to the event if this is sooner. All registrants must provide a credit card number as a guarantee and/or registering or subscribing for our products and services. We also collect certain personal data from other group
at the time of booking. We reserve the right to charge your card in full if payment is not received in accordance with these companies to whom you have given information through their websites. If you do not want us to continue using this
payment terms. We reserve the right to refuse admission if full payment is not received in accordance with these terms. information please notify us at unsubscribe@arena-international.com. Any personal information supplied to SPG Media
4 Cancellations: In the event of cancellation, 100% of the event fee is payable and non-refundable. All cancellation requests Ltd as part of this registration process and/or any other interaction with SPG Media Ltd will be collected, stored and used
must be submitted to us in writing by Monday 2 November 2009. If we agree to your cancellation then all cancellation fees are by SPG Media Ltd its subsidiaries, related companies or affiliates in accordance with the SPG Media Ltd Privacy Policy.
payable immediately after the acceptance of your cancellation in writing by us. Please email privacypolicy@arena-international.com for a copy of the SPG Media Ltd Privacy Policy.
• If you are a Biotech/Pharma Manufacturer and have signed up as a free of charge delegate, you will incur a charge of $499 • The working language of the Event is English. Executives requiring an interpretation service must make their own
if you cancel your registration. arrangements at their own expense.
Arena International Events Group, a trading division of SPG Media Ltd. Registered Office: 55 North Wharf Road, London, W2 1LA, UK. Registered in England No. 01155599. www.arena-international.com
Delegate Details please photocopy form for multiple bookings
Mr/Mrs/Ms/Dr First Name: Surname:
Email: Tel:
Job Title: Fax:
Department:
Company Details
Company: Address:
Town:
Postcode: Country:
VAT Number: Nature of Business:
Payment Details
Purchase Order No.
■ I enclose a cheque drawn on a UK bank (please make cheque payable to SPGMedia Limited and write reference PCVR1209 on the reverse)
■ I will transfer payment to your Lloyds TSB account City Branch, London, UK: 01492549, sort code 30-00-02 (using reference PCVR1209)
■ I would like to pay with my credit card ■ Visa ■ Mastercard ■ AMEX ■ Maestro ■ Solo
Card Number: Expiry Date: Issue Date: CSV*:
Cardholder's Name:
Cardholder's Address:
*The CSV number is the last 3 digit number on the reverse of the card
■ Yes, I have read and understood the terms and cancellations conditions and am happy to proceed with my registration MKEH
Signature Date