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7th Annual Pharmacovigilance (2012) Pp 

 

 
 
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Slide 1: 7th Annual Pharmacovigilance Evaluating the best surveillance strategies and risk management to increase drug safety 30th – 31st January 2012, Visiongain Conference Centre, London, UK BOOK NOW! Key Speakers Dr. Philip Eichorn, Senior Director, Worldwide Safety and Regulatory, Pfizer Dr. Beverley Forsythe, Executive Director Patient Safety, Oncology TA, AstraZeneca Dr. Christina Stroem Moeller, Executive Director, Global Safety, Amgen Dr. Enrica Alteri, Head of Risk Management and Epidemiology, Global Drug Safety, Merck Serono Dr. Celestina Arrigo, Senior Director, Pharmacovigilance Data Quality Expert, UCB Pharma Dr. György Zörényi, Global Safety Physician, AstraZeneca Dr. Julia Appelskog, Nordic Drug Safety Manager, Johnson & Johnson Dr. Sumit Munjal, Consultant Physician, Johnson & Johnson Dr. Rachna Kasliwal, Director Pharmacovigilance, Endocrinology, Ipsen BioPharma Professor Liam Smeeth, Professor of Clinical Epidemiology, London School of Hygiene and Tropical Medicine Dr. Brian Edwards, Principal Consultant, Pharmacovigilance and Drug Safety, NDA Regulatory Services Dr. Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting Philippa Guy, Associate Director, Head of Drug Safety and EU QPPV, 2Health Carol Markwell, Director, Drug Safety Solutions Driving the Industry Forward | www.futurepharmaus.com Media Partners Organised By To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/pharmacovigilance
Slide 2: Conference Introduction 7th Annual Pharmacovigilance 30th - 31st January 2012, London, UK Dear Colleague, he importance of pharmacovigilance has been apparent since the problems T with thalidomide emerged in the 1960s. Since then, various high profile drug recalls, and estimations that more than 750,000 injuries and deaths each year in the US are caused by adverse drug reactions, 1 have meant tightened regulatory controls. t is estimated that the average spend on pharmacovigilance is 6% to 13% of I a company’s total R&D spend 2. From product development in clinical trials to post marketing surveillance, adverse drug reactions are monitored and safety signals investigated. egulations and procedures are continually developing, with changes in EU R legislation set for 2012. Such changes include plans to manage risk proactively, increase communication and transparency, and strengthen companies’ pharmacovigilance systems. isiongains 7th Annual Pharmacovigilance Conference will bring together V industry experts to discuss current regulations, safety surveillance pre and post marketing and review risk management plans to improve drug safety. Media Partners: PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit: www.biotechnology-europe.com Driving the Industry Forward | www.futurepharmaus.com By attending this conference you will: • ain insight into pharmacovigilance throughout the product lifecycle, from clinical G development to patient care • ean about pharmacoepidemiology and drug safety L • ear about the pharmacovigilance activities in biopharmaceutical product H development • valuate risk management plans for improving drug safety E • iscover the right benefit-risk balance D • earn about good pharmacovigilance practice through advances in audits and L inspections • eview the current and changing regulations in the EU, US and Asia R • nderstand how the role of the QPPV impacts patient safety U • sses post marketing surveillance A • iscuss the current methods of reporting D • eview the use of Periodic Safety Update Reports (PSURs) post-authorisation for R safety signals • xamine the principles of signal detection in pharmacovigilance E • etwork with expert industry professionals to build new relationships N I look forward to meeting you at the conference Best regards Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries’ top issues and the solutions top-tier vendors can provide. For further information please visit: www.futurepharmaus.com InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.www.inpharm.com Poster Presentation At a busy conference it is hard to make sure everyone who shares your interests knows what you are doing. Maximise your time at Visiongain’s 7th Annual Pharmacovigilance meeting by sharing your results in a poster presentation. With a plethora of key decision makers, take advantage of this senior networking opportunity. Please send your 200 word abstract, in English, to: info@visiongainglobal.com for approval. The deadline for submissions is Monday 16th January, 2012. Please include contact details for the corresponding author(s). Academic institutions will not be charged a fee if booked as full-price delegates. Posters submitted by pharmaceutical and biotechnology firms will be charged a fee of £199. Posters submitted by service providers / vendors are welcome and will be subject to evaluation. Upon approval a fee of £500 will apply. Two delegates from your organisation must be booked at full price to present a poster. Please note that all posters will be displayed at the discretion of Visiongain Ltd and are subject to approval. Due to limited space, please register your interest early. Sarah Pilgrim Conference Producer Who will attend? VP’s, Directors, Heads, Managers, Scientific Advisors, Consultants of: Pharmacovigilance Pharmacoepidemiology Pharmacogenomics Drug/Product Safety Drug Development Information and Clinical Data Management Clinical Pharmacology Clinical Safety Periodical safety update reports Risk Management Research & Development Quality Assurance Patient Safety Signal Detection Safety Surveillance Outcomes Research Data Analysis Epidemiology Medical Affairs Regulatory Affairs and Compliance Information technology Sales and Marketing Sponsorship and exhibition opportunities This event offers a unique opportunity to meet and do business with some of the key players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can do so at this event by: • Hosting a networking drinks reception • Taking an exhibition space at the conference • Advertising in the delegate documentation pack • Providing branded bags, pens, gifts, etc. If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 7th Annual Pharmacovigilance Conference, please contact us: Damian Gorman, +44 (0)20 7549 9934 damian.gorman@visiongainglobal.com 1 2 Visiongain report, Pharmacovigilance and Other Pharma Regulatory Developments 2010-2020 SCI article, http://www.soci.org/Chemistry-and-Industry/CnI-Data/2010/17/A-risky-business
Slide 3: Day 1 7th Annual Pharmacovigilance Monday 30th January 2012 09:00 09:30 09:40 Registration and refreshments Opening address from the Chair Pharmacovigilance throughout the product life cycle – from clinical development to patient care • egulatory compliance – expedited and periodic reporting R • ntegrating signal detection using totality of information I • mplementing proactive safety risk management I • nderstanding benefit-risk assessment and decision making U • est practices for developing transparency with safety governance committees B Dr. Beverley Forsythe Executive Director Patient Safety, Oncology TA AstraZeneca 12:40 13:40 Networking lunch Do we understand the leverage of pharmacoepidemiology on our patient safety practice? – a safety physician’s point of view • ignal generation or signal evaluation? Our experiences with S pharmacoepidemiology (PE) safety studies in the post-marketing setting • valuation of external epidemiology signals coming from non-industrial E studies- are we good enough to address them? Scientific and business aspects of a possible interaction with the academic field • eneration and evaluation of safety signals by designing in –house G PE studies Strength and limitations • he hierarchy of evidence: randomised studies vs. epidemiology T safety studies • oncordance of quantitative safety signals and the results of C pharmacoepidemiology studies • he future: a move from being “reactive” into being “proactive”. How to T overcome the possible internal and external hurdles? Dr. György Zörényi Global Safety Physician AstraZeneca 10:20 Pharmacovigilance activities in biopharmaceutical product development • n overview into pharmacovigilance activities in biopharmaceutical A product development, including case examples from two new to market biological products • ighlighting the differences with biopharma and long term safety H • ooking at long term safety studies L Dr. Christina Stroem Moeller Executive Director, Global Safety Amgen 14:20 Audits and good pharmacovigilance practice Dr. Celestina Arrigo Senior Director, Pharmacovigilance Data Quality Expert UCB Pharma 11:00 11:20 Morning refreshments 15:00 Safety of biosimilars • Safety data requirements and pharmacovigilance issues • RMPs and post approval studies • Known and potential safety issues • Current and future problems Dr. Sandy Eisen Chief Medical Officer Frontline Pharma Consulting Afternoon Refreshments Sponsor Spotlight Session T ake this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your product/services to the audience. For more information please contact damian.gorman@visiongainglobal.com 15:20 16:00 Pharmacovigilance audits / inspections • urpose, remit and scope P • aking a risk based approach T • racticalities and challenges P • aximising the benefit / learning across audits M • ommon findings C • mpact of new regulations I Philippa Guy Head of Drug Safety and EU QPPV 2Heatlh 12:00 Randomised evaluations utilising electronic health records to measure benefits and risks • ide agreement that we need better methods to assess the beneficial W and adverse effects of drugs in everyday practice • his could be achieved with large scale simple randomised trials T embedded in clinical practice • linicians often face genuine clinical uncertainty with therapeutic choices C made in a quasi-random way • ormal randomisation could usefully exploit this uncertainty to provide F evidence to guide practice • he increasing use of computerised health records might allow us to T mount such trials through prospective randomising of patients with subsequent data collection and follow up undertaken electronically • he talk will present the case for such trials, discuss the barriers to their T implementation and how such barriers might be overcome Professor Liam Smeeth Professor of Clinical Epidemiology London School of Hygiene and Tropical Medicine 16:40 Closing remarks from the Chair 16:50 Networking drinks Take your discussions further and build new relationships in a relaxed and informal setting Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011
Slide 4: Day 2 7th Annual Pharmacovigilance Tuesday 31st January 2012 09:00 09:30 09:40 Registration and refreshments Opening address from the Chair Special problems of pharmacovigilance for generic products • ith the current search for new business models, many big pharma are W energetically exploring and pursuing the generics market. • e often find there are all sorts of special circumstances that arise, and W there often isn’t the expertise in house to deal with them. • hat is the importance of the pharmacovigilance agreement if there’s a W partner company involved? • hat does a risk management plan for a generic compound look like? W Dr. Phillip Eichorn Senior Director Worldwide Safety and Regulatory Pfizer 12:40 13:40 Networking lunch Post marketing surveillance and reporting of ADRs: what’s new? • mpact of new proposed legislation I • eterogeneity of data sources H • vidence for good quality processes E • ustomisation of training on the human factor C • lace of continuous improvement P • ole of EU QPPV in driving policy and setting standards R Dr. Brian Edwards Principal Consultant, Pharmacovigilance & Drug Safety NDA Regulatory Services 14:20 10:20 Methods in post-marketing drug safety surveillance • pontaneous reporting and drug registries S • rescription event monitoring (PEM) P • atabase related studies D Dr. Rachna Kasliwal Director Pharmacovigilance, Endocrinology Ipsen BioPharma Effective risk management plan – practical approaches to maximise patient safety • ew requirements for risk management in pharma package N • ow to design a robust and comprehensive risk management plan H • xecuting a risk management plan that incorporates developmental, E clinical and epidemiological safety data combined with post market surveillance to ensure product safety • valuating pharmacovigilance activities to characterise the potential or E identified risks in a timely defined manner; importance of additional risk minimisation activities • nsuring effective risk management throughout the full product lifecycle E • ommunicating safety and comparative benefit/risk to health care C professionals, patients and the public Dr. Julia Appelskog Nordic Drug Safety Manager Johnson & Johnson 15:00 15:20 Afternoon refreshments Sponsor Spotlight Session T ake this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your product/services to the audience. For more information please contact damian.gorman@visiongainglobal.com 16:00 11:00 11:20 PSURs– issues with content and submission • ommon inspection findings C • ssessment reports A • ork sharing and synchronisation W • lanned changes in Europe P Carol Markwell Director Drug Safety Solutions Morning refreshments From risk management to benefit-risk management: a paradigm shift • mpact on drug development approach I • mpact on life-cycle management I • mpact on companies’ processes I • eeting patients’ needs M Dr. Enrica Alteri Head Risk Management & Epidemiology, Global Drug Safety Merck Serono 16:40 16:50 Closing remarks from the Chair End of Conference 12:00 Benefit-risk assessment in pharmacovigilance • rinciples, methodology and finding ‘the balance’ P • takeholders and risk management S • ew initiatives - EMA N Dr. Sumit Munjal Consultant Physician – UK (Global) Pharmacovigilance Johnson & Johnson
Slide 5: Registration Form 7th Annual Pharmacovigilance 30th - 31st January 2012, London, UK Angel Conf. code PP Standard Prices Conference only Number of bookings: Fee: £1299 VAT: £259.80 Total cost: Total: £1558.80 7th Annual Pharmacovigilance 30th - 31st January 2012 Location: Visiongain Conference Centre Address: 230 City Road London EC1V 2TT UK Pentonville Road Ci ty Ro ad Old Street Old Street Promotional Literature Distribution Distribution of your company’s promotional literature to all conference attendees Fee: £999 VAT: £199.80 Total: £1198.80 City Road Details Forename: Job Title: Main Switchboard Number: Address: Surname: Company: How to book Email: piyush.patel@visiongain.com Web: http://www.visiongain.com/pharmacovigilance UK Office: Tel: +44(0) 20 7549 9961 Fax: +44(0) 20 7549 9932 Visiongain Ltd BSG House 226-236 City Road London EC1V 2QY UK Country: Phone: Email: Signature: Postcode: Fax: General information I confirm that I have read and agree to the terms and conditions of booking Methods of payment Payment must be made in sterling By Mail: Complete and return your signed registration form together with your cheque payable to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK By Fax: Complete and fax your signed registration form with your credit card details to +44 (0) 20 7549 9932 By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 By Bank Transfer: Visiongain Ltd Barclays Bank Piccadilly Branch 48 Regent Street London, W1B 5RA Please debit my credit card: Access MasterCard Visa American Express A/C: visiongain Ltd Sort Code: 20-71-64 Account No: 6038 7118 Swift Code: BARC GB22 IBAN: GB80 BARC 20716460387118 Card number: Expiry Date: Security number (last 3 digits on back of credit card): Signature: Cardholder’s name: Venue: Visiongain Conference Centre 230 City Road, London, EC1V 2TT. United Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 9004 / +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343 http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503, http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340 Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. Visiongain Ltd reserves the right to charge interest on unpaid invoices. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places between conferences. However, if you cannot attend the conference, you may make a substitution/name change at any time, as long as we are informed in writing by email, fax or post. Name changes and substitutions must be from the same company or organisation and are not transferable between countries. Please note that discounted delegates places at a visiongain event are non refundable. Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, excluding substitutions/name changes, requested by the customer. This will be charged to the customer by credit card prior to the changes being made. Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or expenses, which may be incurred by the customer as a consequence of the event being postponed or cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the cost of the registration, travel and expenses. Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data Protection Act 1988. Your personal information contained in this form may be used to update you on visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We may also share your data with external companies offering complementary products or services. If you wish for your details to be amended, suppressed or not passed on to any external third party, please send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details. Please allow approximately 30 days for your removal or update request to be applied to our database. Following your removal or update request, you may receive additional pieces of communication from visiongain Ltd during the transitional period, whilst the changes are coming into effect. Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain). VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT. How we will contact you: Visiongain Ltd’s preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you. Unable to attend Obviously nothing compares to being there but you need not miss out. Simply tick the box and send with your payment. You will receive speaker talks in PDFs two weeks after the event. Yes, please send me speaker talks Price£550 VAT:£110 Total:£660 News updates Please tick if you do not want to receive email news updates in the future www.visiongain.com/pharmacovigilance

   
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