7th Annual  Pharmacovigilance  Evaluating the best surveillance strategies and risk management to increase drug safety 30t...
Conference Introduction                                                                                                   ...
Day 1                                                                                                                   7t...
Day 2                                                                                                 7th Annual Pharmacov...
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7th Annual Pharmacovigilance (2012) Pp


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7th Annual Pharmacovigilance (2012) Pp

  1. 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.comMedia Partners Organised By To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/pharmacovigilance
  2. 2. Conference Introduction 7th Annual Pharmacovigilance 30th - 31st January 2012, London, UK Dear Colleague, Media Partners: he importance of pharmacovigilance has been apparent since the problems T PharmiWeb.com is the leading industry-sponsored portal for with thalidomide emerged in the 1960s. Since then, various high profile drug the pharmaceutical sector. Supported by most of the leading recalls, and estimations that more than 750,000 injuries and deaths each pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, year in the US are caused by adverse drug reactions, 1 have meant tightened events listings and international jobs to industry professionals across Europe and the US. regulatory controls. For further information please email: corporate@pharmiweb.com t is estimated that the average spend on pharmacovigilance is 6% to 13% of I BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY a company’s total R&D spend 2. From product development in clinical trials to WORLD. It is based and located in Warsaw, Poland. post marketing surveillance, adverse drug reactions are monitored and safety Biotechnology World was founded in 2007 to provide the world’s biotech and pharma signals investigated. information and market to make it universally accessible and useful for scientific egulations and procedures are continually developing, with changes in EU R and business processes. Its first step to fulfilling that mission was building the legislation set for 2012. Such changes include plans to manage risk proactively, BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in increase communication and transparency, and strengthen companies’ different channels. BIOTECHNOLOGY EUROPE offers companies completed internet pharmacovigilance systems. public relations, publication and marketing solutions. One of the mains goals of isiongains 7th Annual Pharmacovigilance Conference will bring together V BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to industry experts to discuss current regulations, safety surveillance pre and post global biotechnology, pharmaceutical and life science activities. marketing and review risk management plans to improve drug safety. For further information please visit: www.biotechnology-europe.com By attending this conference you will: Future Pharmaceuticals has forged powerful relationships Driving the Industry Forward | www.futurepharmaus.com • ain insight into pharmacovigilance throughout the product lifecycle, from clinical G with key industry leaders to provide a platform for successful development to patient care brand recognition, and for senior decision-makers to have the means to procure and • ean about pharmacoepidemiology and drug safety L plan implementation strategies based on the topics covered. Positioned to be an • ear about the pharmacovigilance activities in biopharmaceutical product H authoritative resource within top pharma companies as well as small, specialty, and development biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into • valuate risk management plans for improving drug safety E a highly targeted and responsive audience, bridging the gap between the industries’ top issues and the solutions top-tier vendors can provide. • iscover the right benefit-risk balance D For further information please visit: www.futurepharmaus.com • earn about good pharmacovigilance practice through advances in audits and L inspections InPharm is the online platform for exclusive pharmaceutical • eview the current and changing regulations in the EU, US and Asia R news, comment, contracts, services, jobs and events and is • nderstand how the role of the QPPV impacts patient safety U home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.www.inpharm.com • 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 Poster Presentation • etwork with expert industry professionals to build new relationships N At a busy conference it is hard to make sure everyone who shares your interests knows I look forward to meeting you at the conference 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 Best regards 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 Sarah Pilgrim submitted by pharmaceutical and biotechnology firms will be charged a fee of £199. Conference Producer 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 Who will attend? subject to approval. Due to limited space, please register your interest early. VP’s, Directors, Heads, Managers, Scientific Advisors, Consultants of: Pharmacovigilance Pharmacoepidemiology Pharmacogenomics Drug/Product Safety Sponsorship and exhibition opportunities Drug Development Information and Clinical Data Management This event offers a unique opportunity to meet and do business with some of the key Clinical Pharmacology players in the pharmaceutical and biotech industries. If you have a service or product Clinical Safety Periodical safety update reports to promote, you can do so at this event by: Risk Management • Hosting a networking drinks reception Research & Development Quality Assurance • Taking an exhibition space at the conference Patient Safety • Advertising in the delegate documentation pack Signal Detection • Providing branded bags, pens, gifts, etc. Safety Surveillance Outcomes Research If you would like more information on the range of sponsorship or exhibition Data Analysis possibilities for visiongains 7th Annual Pharmacovigilance Conference, please contact Epidemiology Medical Affairs us: Regulatory Affairs and Compliance Damian Gorman, +44 (0)20 7549 9934 Information technology Sales and Marketing damian.gorman@visiongainglobal.com Visiongain report, Pharmacovigilance and Other Pharma Regulatory Developments 2010-20201 SCI article, http://www.soci.org/Chemistry-and-Industry/CnI-Data/2010/17/A-risky-business2
  3. 3. Day 1 7th Annual Pharmacovigilance Monday 30th January 2012 09:00 Registration and refreshments 12:40 Networking lunch 09:30 Opening address from the Chair 13:40 Do we understand the leverage of pharmacoepidemiology on our patient safety 09:40 Pharmacovigilance throughout the product life cycle practice? – a safety physician’s point of view – from clinical development to patient care • ignal generation or signal evaluation? Our experiences with S • egulatory compliance – expedited and periodic reporting R pharmacoepidemiology (PE) safety studies in the post-marketing setting • ntegrating signal detection using totality of information I • valuation of external epidemiology signals coming from non-industrial E • mplementing proactive safety risk management I studies- are we good enough to address them? Scientific and business • nderstanding benefit-risk assessment and decision making U aspects of a possible interaction with the academic field • est practices for developing transparency with safety governance committees B • eneration and evaluation of safety signals by designing in –house G PE studies Strength and limitations Dr. Beverley Forsythe Executive Director Patient Safety, Oncology TA • he hierarchy of evidence: randomised studies vs. epidemiology T AstraZeneca safety studies • oncordance of quantitative safety signals and the results of C 10:20 Pharmacovigilance activities in biopharmaceutical pharmacoepidemiology studies product development • he future: a move from being “reactive” into being “proactive”. How to T • n overview into pharmacovigilance activities in biopharmaceutical A overcome the possible internal and external hurdles? product development, including case examples from two new to market Dr. György Zörényi biological products Global Safety Physician • ighlighting the differences with biopharma and long term safety H AstraZeneca • ooking at long term safety studies L Dr. Christina Stroem Moeller 14:20 Audits and good pharmacovigilance practice Executive Director, Global Safety Dr. Celestina Arrigo Amgen Senior Director, Pharmacovigilance Data Quality Expert UCB Pharma 11:00 Morning refreshments 15:00 Afternoon Refreshments 11:20 Safety of biosimilars • Safety data requirements and pharmacovigilance issues 15:20 Sponsor Spotlight Session • RMPs and post approval studies T ake this unique opportunity to be a part of the conference theme, network, • Known and potential safety issues share ideas and provide an overview of your product/services to the audience. • Current and future problems For more information please contact damian.gorman@visiongainglobal.com Dr. Sandy Eisen Chief Medical Officer 16:00 Pharmacovigilance audits / inspections Frontline Pharma Consulting • urpose, remit and scope P • aking a risk based approach T 12:00 Randomised evaluations utilising electronic health • racticalities and challenges P records to measure benefits and risks • aximising the benefit / learning across audits M • ide agreement that we need better methods to assess the beneficial W and adverse effects of drugs in everyday practice • ommon findings C • his could be achieved with large scale simple randomised trials T • mpact of new regulations I embedded in clinical practice Philippa Guy • linicians often face genuine clinical uncertainty with therapeutic choices C Head of Drug Safety and EU QPPV made in a quasi-random way 2Heatlh • 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 16:40 Closing remarks from the Chair 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 16:50 Networking drinks Professor Liam Smeeth Take your discussions further and build new Professor of Clinical Epidemiology relationships in a relaxed and informal setting London School of Hygiene and Tropical Medicine 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
  4. 4. Day 2 7th Annual Pharmacovigilance Tuesday 31st January 201209:00 Registration and refreshments 12:40 Networking lunch09:30 Opening address from the Chair 13:40 Post marketing surveillance and reporting of ADRs: what’s new?09:40 Special problems of pharmacovigilance for • mpact of new proposed legislation I generic products • eterogeneity of data sources H • ith the current search for new business models, many big pharma are W energetically exploring and pursuing the generics market. • vidence for good quality processes E • e often find there are all sorts of special circumstances that arise, and W • ustomisation of training on the human factor C there often isn’t the expertise in house to deal with them. • lace of continuous improvement P • hat is the importance of the pharmacovigilance agreement if there’s a W partner company involved? • ole of EU QPPV in driving policy and setting standards R • hat does a risk management plan for a generic compound look like? W Dr. Brian Edwards Dr. Phillip Eichorn Principal Consultant, Pharmacovigilance & Drug Safety Senior Director Worldwide Safety and Regulatory NDA Regulatory Services Pfizer 14:20 Methods in post-marketing drug safety surveillance10:20 Effective risk management plan – practical • pontaneous reporting and drug registries S approaches to maximise patient safety • rescription event monitoring (PEM) P • ew requirements for risk management in pharma package N • ow to design a robust and comprehensive risk management plan H • atabase related studies D • xecuting a risk management plan that incorporates developmental, E Dr. Rachna Kasliwal clinical and epidemiological safety data combined with post market Director Pharmacovigilance, Endocrinology surveillance to ensure product safety Ipsen BioPharma • valuating pharmacovigilance activities to characterise the potential or E identified risks in a timely defined manner; importance of additional risk 15:00 Afternoon refreshments minimisation activities • nsuring effective risk management throughout the full product lifecycle E 15:20 Sponsor Spotlight Session • ommunicating safety and comparative benefit/risk to health care C T ake this unique opportunity to be a part of the conference professionals, patients and the public theme, network, share ideas and provide an overview of your Dr. Julia Appelskog product/services to the audience. For more information please contact Nordic Drug Safety Manager damian.gorman@visiongainglobal.com Johnson & Johnson 16:00 PSURs– issues with content and submission11:00 Morning refreshments • ommon inspection findings C11:20 From risk management to benefit-risk management: • ssessment reports A a paradigm shift • ork sharing and synchronisation W • mpact on drug development approach I • lanned changes in Europe P • mpact on life-cycle management I Carol Markwell • mpact on companies’ processes I Director • eeting patients’ needs M Drug Safety Solutions Dr. Enrica Alteri Head Risk Management & Epidemiology, Global Drug Safety Merck Serono 16:40 Closing remarks from the Chair12:00 Benefit-risk assessment in pharmacovigilance 16:50 End of Conference • 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
  5. 5. Registration Form 7th Annual Pharmacovigilance 30th - 31st January 2012, London, UK Angel Conf. code PP Pentonville Road 7th Annual CiStandard Prices ty Pharmacovigilance Ro adConference only Fee: £1299 VAT: £259.80 Total: £1558.80 30th - 31st January 2012 Old StreetNumber of bookings: Total cost: Location: Visiongain Conference Centre Old Street Address: 230 City RoadPromotional Literature Distribution City Road LondonDistribution of your company’s promotional literature to all conference attendees EC1V 2TT UK Fee: £999 VAT: £199.80 Total: £1198.80Details How to bookForename: Surname: Email: piyush.patel@visiongain.com Web: http://www.visiongain.com/pharmacovigilance Job Title: Company: UK Office: Tel: +44(0) 20 7549 9961 Fax: +44(0) 20 7549 9932 Main Switchboard Number: Visiongain Ltd BSG HouseAddress: 226-236 City Road London EC1V 2QY UKCountry: Postcode: General information Venue: Visiongain Conference Centre 230 City Road, London, EC1V 2TT. United Kingdom. Closest tube Phone: Fax: 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 8343Email: 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 Signature: 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 I confirm that I have read and agree to the terms and conditions of booking 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.Methods of payment Substitutions/name changes or cancellations: There is a 50% liability on all bookings once Payment must be made in sterling 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 By Mail: Complete and return your signed registration form together with your cheque payable must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK 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 By Fax: Complete and fax your signed registration form with your credit card details 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.to +44 (0) 20 7549 9932 Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details excluding substitutions/name changes, requested by the customer. This will be charged to the customer by credit card prior to the changes being made.By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive By Bank Transfer: 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 Visiongain Ltd A/C: visiongain Ltd 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 Barclays Bank Sort Code: 20-71-64 cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the Piccadilly Branch Account No: 6038 7118 cost of the registration, travel and expenses.48 Regent Street Swift Code: BARC GB22 Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data London, W1B 5RA IBAN: GB80 BARC 20716460387118 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 Please debit my credit card: 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 Access MasterCard Visa American Express 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 Card number: 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 Expiry Date: recommend you obtain). VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT Security number (last 3 digits on back of credit card): incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT.Signature: 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.Cardholder’s name: Unable to attend Obviously nothing compares to being there but you need not miss out. Simply tick the box and send News updates with your payment. You will receive speaker talks in PDFs two weeks after the event.Please tick if you do not want to receive email news updates in the future Yes, please send me speaker talks Price£550 VAT:£110 Total:£660 www.visiongain.com/pharmacovigilance