Report of The International Publication Planning Association's 7th Annual Meeting
An in-depth report from the 7th Annual Meeting of the International Publication Planning Association (TIPPA) held in San Francisco, CA, USA, 15-16 June 2009. Written by Elizabeth (Liz) Wager.
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CONTENTS Programme About the author Current challenges in publication planning The FDA Amendments Act Risk mitigation in publication planning Doing more with less Coping with a global organisation Clinical trial disclosure requirements Generating and communicating economic and humanistic value to payers and decision makers Editors’ panel Senate Finance Committee inquiries GPP and GPP2 Tackling the authorship debate Reprints and supplements Publication and reporting bias Firewalls: responding to the current regulatory environment The TIPPA member survey Conclusions ReferencesABOUT THE AUTHOR Elizabeth (Liz) Wager is the author of books on Getting Research Published: An A to Z of Publication Strategy and How to Survive Peer Review . She is a co-author of Good Publication Practice For Pharmaceutical Companies and the European Medical Writers Association guidelines on the role of medical writers. After obtaining a first-class zoology degree from Oxford in 1983, she worked for Blackwell Scientific Publications, Janssen-Cilag then Glaxo Wellcome. In 2001, she set up her own company, Sideview, which provides training, writing, editing and publication consultancy services. Since going freelance, Liz has run courses on publication strategy, medical writing and publication ethics on five continents. She is the Chair of COPE (the Committee on Publication Ethics) and a member of: the BMJ ’s Ethics Committee, the World Association of Medical Editors Ethics Committee, and the World Health Organization Scientific Advisory Group on trial registration. She is also a Visiting Fellow at the UK Cochrane Centre.EXECUTIVE SUMMARY The reputation of publication planners continues to require defence against accusations of ghost writing and ghost management. Demands for increased transparency remain prevalent, while the age-old issue of industry sponsorship still provokes unwarranted prejudice. Companies are responding positively, with the introduction of new policies on the disclosure of results and an increased focus on compliance. However, this has, in turn, led to a diverse range of guidelines and new challenges for publication planners in interpreting them. The emergence of online communication channels such as blogs, which can often contain misinformation or imbalanced commentary, lends new complications for company communication strategies. The International Publication Planning Association’s 7th Annual Meeting, covered in depth in this Conference Insights review, looked at the regulatory, ethical and operational challenges in publication planning, and presented an industry in transition. Beginning with an overview of the evolving regulatory frameworks for trial registration and results disclosure, and their impact on publication planning, professionals shared insights into how the industry is responding and what more can be done to enhance its reputation among health professionals and journal editors. The meeting also explored critical issues such as risk mitigation, budget management and the issues of authorship and developments in health economic and outcomes research from the perspectives of journal editors, publication planning professionals and medical communications experts.PROGRAMME Chair: Dan Donovan, President, Envision Pharma, Senior Vice President, United BioSource CorporationDAY ONE FDAAA, Efficiency & Accelerated Time Lines: How Does it All Add Up? Panellists: Catherine Arnaudeau-Bégard, Lead Manager Publication Planning, Global Medical Affairs, UCB Pharma S.A. Tricia Deja, Manager, Medical Publications, Astellas Pharma Global Development, Inc. Liz Wager, Managing Director, Sideview Moderator: Maureen F Garrity, Director, Medical Publications, Astellas Pharma Global Development, Inc.Risk Mitigation in Publication Planning: How to Proactively Face the Industry’s Newest Challenges Dan Donovan, President, Envision Pharma, Senior Vice President, United BioSource CorporationDoing More with Less: How Publication Planners Can Maintain (& Improve) Fiscal Support from Senior Management Elizabeth Crane, Senior Manager, Medical Publications, Astellas Pharma Global Development, Inc.Coping with a Global Organization: The Pros & Cons of the Most Popular Models Panellists: Mark Molenda, Associate Director, Medical Affairs Strategic Trials Team, Centocor Ortho-Biotech Services LLC Matt Monberg, Senior Scientific Communications Associate, Lilly USA LLC Moderator: Maureen F Garrity, Director, Publications, Astellas Pharma Global Development, Inc.The Changing Healthcare Environment: Generating & Communicating Economic & Humanistic Value to Payers & Decision Makers Christopher Leibman, Senior Director - Pharmacoeconomics, Elan Pharmaceuticals Michael R Pollock, President, Reynolds Pollock & AssociatesClinical Trial Disclosures: Hot Button Issues & the Latest Updates Scott Lassman, Partner, WilmerhaleThe Editors’ Perspective: Promoting a More Effective Partnership between Publication Planners and Journals Panellists: Michael Callaham, Editor, Annals of Emergency Medicine Mikel Gray, University of Virginia, Department of Urology and School of Nursing, Editor in Chief, Journal of Wound, Ostomy and Continence Nursing Charon Pierson, Editor-in-Chief, Journal of the Academy of Nurse Practitioners Moderator: Elizabeth Loder, Clinical Editor (Secondary Care), BMJDAY TWO Senate Finance Program for Medical Publication Professionals Discussion Leader: Dan Donovan, President, Envision Pharma, Senior Vice President, United BioSource CorporationWhat You Need to Know About GPP2: Updates and Implications for Publication Planners Catherine Arnaudeau-Bégard, Lead Manager Publication Planning, Global Medical Affairs, UCB Pharma S.A. Art Gertel, VP, Strategic Regulatory Consulting, Medical Writing & QA, Beardsworth Consulting Group, Inc. Liz Wager, Managing Director, SideviewTackling the Authorship Debate: A Practical Discussion on Disclosure, Transparency & Positive Steps You Can Take to Move Beyond the Guidelines Panellists: Nancy Bormann, Associate Director, Medical Communications, Biogen Idec James T Magrann, Publisher, Current Medical Research and Opinion Moderator: Kirby Lee, Assistant Professor of Clinical Pharmacy at the School of Pharmacy and Institute of Health Policy Studies, School of Medicine, University of California, San FranciscoReviews, Reprints & Supplements: Demystifying the Current Environment Panellists: Catherine Arnaudeau-Bégard, Lead Manager Publication Planning, Global Medical Affairs, UCB Pharma S.A. Mikel Gray, University of Virginia, Department of Urology and School of Nursing, Editor in Chief, Journal of Wound, Ostomy and Continence Nursing James T Magrann, Publisher, Current Medical Research and Opinion Craig Smith, Senior Editor and Manager, Supplement Division, Elsevier Moderator: Elizabeth Crane, Senior Manager, Medical Publications, Astellas Pharma Global Development, Inc.Publication and Reporting Bias of Clinical Trials Submitted to the FDA Kirby Lee, Assistant Professor of Clinical Pharmacy at the School of Pharmacy and Institute of Health Policy Studies, School of Medicine, University of California, San FranciscoFirewalls: How do we Reorganize and Conduct Business to Respond to the Current Environment? Joseph B Laudano, Senior Director, Medical Affairs, Forest Research Institute Ansgar Conrad, Senior Manager, Medical Communications, Actelion Pharmaceuticals US, Inc. Leslie Meltzer, Manager, Medical Communications, Actelion Pharmaceuticals US, Inc.