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Next Events

	Sep 2008 - Atlanta, Georgia: BioPharm America 2008
	Sep 2008 - Zurich: Zurich08 Biotech in Europe Investor Forum
	Sep 2008 - London: Innovation Forum

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09.09.08 - 10.09.08	BioPharm America 2008
	Grand Hyatt Hotel in Buckhead, Atlanta Atlanta, Georgia, USA
	Based on the same winning formula used in EBD Group’s distinguished European partnering conferences BIO-Europe and BIO-Europe Spring®, BioPharm America is expected to become the premier stand-alone bio-pharma partnering event in North America. With a clear focus on generating one-to-one meetings for attendees, BioPharm America offers an unrivalled opportunity for participants across the entire biotech value-chain to identify and enter into strategic relationships.
	Event website
Contact	Mrs. Elaine Bundy
	E-mail


23.09.08 - 24.09.08	Zurich08 Biotech in Europe Investor Forum
	Swissôtel Zurich, Switzerland
	The forum will provide presenting opportunities for over 80 public & private companies (85 companies in 2007). With themes including Public Markets, Partnering, Private Equity & Venture Capital and Devices, the forum promises to provide a great platform to network with your peers, gain excellent exposure and meet emerging companies. Day one will host presentations from public and large venture backed companies from Europe and North America. The second day of the forum will feature presentations from privately funded companies and a special track for Start-Ups & Medtech Companies. The forum will host a networking dinner on the evening of the 23rd September.
	Event website
Contact	Mrs. Rosa Lippard
	E-mail
Further information	Details


29.09.08 - 30.09.08	Innovation Forum
	Marriott London Regents Park , 128 King Henrys Road London, UK
	A brand new DIA Conference featuring an expert programme committee and speakers from the EMEA, CHMP Working Group, EFPIA, European Commission, EBE, EuropaBio, Eucomed and senior representatives from industry. The conference will involve all stakeholders including regulators, industry, academia and patient groups. The conference is organised over two days. The first day will address the progress with the implementation of the Innovative Medicines Initiative and the EMEA initiatives in relation to support innovation including the qualification of biomarkers and new methodologies. The second day will focus on the practical aspects to implement the Regulation on Advanced Therapy.
	Event website
Contact	Mrs. Talana Bertschi
	E-mail
Further information	Details


06.10.08 - 08.10.08	The 5th TOPRA Annual Symposium 2008
	Corinthia Grand Hotel Royal, Erzsébet krt. 43-49 Budapest, Hungary
	TOPRA, The Organisation for Professionals in Regulatory Affairs organises this highly successful Annual Symposium, building upon a 30 year track record in delivering the premier annual Regulatory Affairs conference for Europe and it attracts excellent high-level speakers. These speakers include government Ministers, Heads of Agencies, key officials from the European Commission, Heads of Unit from EMEA, leading pioneers and practitioners from within industry, pan-European policymakers, patient groups and consultants who examine topical issues in European and global regulatory affairs. Building relationships is an important part of the TOPRA Symposium and this year we welcome The National Institute of Pharmacy, Hungary who will be assisting with the organisation of the programme. This meeting will be an ideal opportunity to get to know this key agency better. In addition, we are also working with HURAS, the Hungarian Regulatory Affairs Society to bring you an exciting symposium that reflects this region of Europe. We once again have an international speaker panel, including many speakers from your local region, presentations on key regulatory issues, with a particular focus on Eastern Europe and an exciting social programme that promises to attract a Europe-wide audience of Regulatory Affairs Professionals. Among the confirmed speakers are Janos Borvendeg, Hungarian Institute of Pharmacy and CHMP member Christopher Bravery, Director Advanced Therapies, ERA Consulting Ltd, UK Gary Dodson, Manager, RA Operations Europe, Baxter Healthcare Corporation, Inc, Austria Gabriele Eibenstein, Head of Unit Regulatory Affairs, BfArM, Germany Sibille Grub, Novartis, Switzerland Peter James, Managing Director, Dao-eRA Limited, UK Peter Karolyi, EMEA Mária Kenéz, Head of International Regulatory Affairs EGIS, Hungary Xavier Luria Oller, Head of Sector, Safety and Efficacy of Medicines, EMEA Tamas Paal, Professor of Regulatory Affairs, Hungary Kristin Raudsepp, Director General, Ravimiamet, Estonian Agency Agnes Saint Raymond, EMEA Norman Schmuff, FDA, USA Ilia Slavov, MSD/President of HURAS, Hungary Jean-Hugues Trouvin, Chairman of the EMEA BWP, France Daniela Vasilescu, National Medicines Agency, Romania Martina Weise, BfArM and V Chair EMEA Biosimilars WP, Germany Gergely Zajzon, Head of Development and Database Department, Institute of Pharmacy, Hungary The TOPRA Symposium provides a forum for detailed discussion of all the most important regulatory issues of the day. It is an opportunity to get right up to date with the latest information and to network with industry and agency colleagues, not only in formal sessions but also informally during breaks and in the evenings. A new feature this year is specific sessions from some of the TOPRA Special Interest groups covering "e" technology, Biotechnology and Chemistry/Pharmacy (CMC). In addition to the traditionally strong core symposium, two additional symposia are also organised to recognise the specialised needs of the whole industry. With advice from the European Commission, the EMEA and other key bodies in the EU, TOPRA has developed parallel symposia on Veterinary Medicines and Medical Technologies. For more information, please visit www.toprasymposium.com or contact TOPRA on email: meetings@topra.org or tel: +44 (0) 207 538 9502
	Event website
Contact	Mrs. Sarah Roberts
	E-mail
Further information	Details


07.10.08 - 09.10.08	BIOTECHNICA
	Hannover Fairgrounds (Deutsche Messe), Messegelaende Hannover, Germany
	BIOTECHNICA is Europe's largest event for life sciences and biotechnology. With its four columns Trade Fair. Conferences. Partnering. Award. BIOTECHNICA offers a central and international platform for developing business leads, forging strategic alliances and driving knowledge transfer for and within the biotech industry.
	Event website
Contact	Mrs. Stephanie Wagner
	E-mail
Further information	Details


20.10.08 - 23.10.08	2nd Annual Clinical Forum
	Ljubljana Exhibition & Convention Centre , Dunajska cesta - p.p. 3517 Ljubljana, 1000 , Slovenia
	Data Driven Drug Development Decisions In its second year after a very successful first event 2007, the DIA Clinical Forum will again provide a broad learning, discussion and networking opportunity for clinical research professionals. This time, clinical data will be the focus of numerous tutorials, sessions and cross-functional workshops. New and experienced colleagues in the field of clinical and safety data management, statistics, medical information, pharmacovigilance, information technology and validation will be able to attend a wide range of educational forums, discuss experiences and uncover solutions. In addition to established formats like tutorials and sessions de-dicated to the different areas of interest, cross-functional workshops looking at a particular operations topic from different angles will provide the opportunity to meet colleagues from business partner functions to discuss new ideas, interfaces and data streams. We very much look forward to meeting you in Ljubljana! Jens Reinhold, Head of Non-Interventional Studies, Bayer Schering Pharma AG, Germany
	Event website
Contact	Mrs. Talana Bertschi
	E-mail
Further information	Details


23.10.08 - 24.10.08	Project Management Excellence in Life Sciences
	Grand Union Hotel , Miklosiceva 1 Ljubljana, 1000 , Slovenia
	One Conference, Two Locations The conference will be held simultaneously at two locations with joint sessions between the US and European attendees US Location: Marriott Wardman Park Hotel 2660 Woodley Rd NW Washington, DC 20008 Learn Pharma, Biotech, and Medical Devices Project Management Best Practices from Around the World. This two-day conference will explore the skills, processes, and tools necessary to achieve project management success at your organization. Leaders in their fields will present top-notch lectures and facilitate lively discussions on how they have been successful in their organization and where they have observed successful leadership in other settings. And don’t forget your business cards, because this conference will provide extensive networking opportunities to help you grow your network of project management colleagues from whom you can learn for a lifetime. Tutorials will be held on October 22, 2008 in both locations. Monitor DIA website for updates and detailed tutorial information.
	Event website
Contact	Mrs. Talana Bertschi
	E-mail
Further information	Details


26.10.08 - 28.10.08	BIOCOM Investor Conference
	Hyatt Regency La Jolla, 3777 La Jolla Village Drive San Diego, CA, USA
	The third annual BIOCOM Investor Conference is a unique opportunity to gain access to leading technology from Southern California, one of the industry’s largest life science communities, with over 800 companies producing life saving technologies and products to improve quality of life for patients. Highlighting investment opportunities, over 60 of these leading life science companies will present to principal institutional and private equity investors. The conference will provide ample networking opportunities through plenary sessions, one-on-one meetings and company presentations.
	Event website


30.10.08 - 31.10.08	2nd Paediatrics Forum
	NH Harrington Hall , 5-25 Harrington Gardens London , UK
	This conference is organised in parallel with the following DIA programme: Pharmaceutical Patents and Regulatory Exclusivity Workshop “An Update on Key Issues” The two workshops run independently but will share the same venue as well as two important joint sessions on the new paediatrics regime, allowing delegates excellent multi-disciplinary networking opportunities. Session Overview • EU and U.S. - Comparison of legislations - Summary of experiences - Transatlantic simplification for paediatrics • Case Studies - Company experience of WR into PIP (and possibly PIP to WR) - Company experience in a paediatric rare disease - Experience from the regulators • Formulations - Company experience on developing paediatric formulations - EU paediatric formulation expert view - Experience from the regulators in U.S. • Suggestions for the Future - Interpretation Issues - Way forward - Impact on global (both adult and children) development plans for industry • The Paediatric Regulation and Intellectual Property (IP) Rights (jointly with the DIA Patents and Regulatory Exclusivity Workshop) - Overview of the IP aspects of the Paediatric Regulation - Basic principles of SPCs - Basic conditions for obtaining the SPC extension • Challenges for Obtaining the Supplementary Protection Certificate (SPC) Extension (jointly with the DIA Patents and Regulatory Exclusivity Workshop) - Practices of National Patent Offices - Industry perspective - Will the regime be effective? - How to obtain the necessary regulatory documents? • Compliance Check - What is required for validation of MA or variation application? - Role of the PDCO - Process at NCA level - Best Practices to ensure compliance • Conclusions and Issues to Be Resolved - Update on the worksharing exercise acc to Art 45 and 46 - Remaining Legal Questions - Ensuring success of the Paediatrics Regulation
	Event website
Contact	Mrs. Talana Bertschi
	E-mail
Further information	Details


30.10.08 - 31.10.08	Pharmaceutical Patents and Regulatory Exclusivity Workshop
	NH Harrington Hall , 5-25 Harrington Gardens London, UK
	This conference is organised in parallel with the following DIA programme: 2nd DIA Paediatric Forum The two workshops run independently but will share the same venue as well as two important joint sessions on the new paediatrics regime, allowing delegates excellent multi-disciplinary networking opportunities. Session Overview Key Developments on Pharmaceutical Patents - Recent developments on patentability - Update on biotechnology patents - Second medical use patent claims Key Developments on Data Exclusivity - Interpretation of the revised pharmaceutical legislation - Biosimilars - Generic prescribing and subsitution National Developments in Patent Law and Practices - Germany - UK - The Netherlands International Perspective - Challenges in other European countries - View from Turkey - Doha and compulsory licensing - International view from industry The Paediatric Regulation and Intellectual Property (IP) Rights (jointly with the DIA Paediatric Forum) - Overview of the IP aspects of the Paediatric Regulation - Basic principles of SPCs - Basic conditions for obtaining the SPC extension Challenges for Obtaining the Supplementary Protection Certificate (SPC) Extension (jointly with the DIA Paediatric Forum) - Practices of National Patent Offices - How to obtain the necessary regulatory documents? - Industry perspective - Will the regime be effective? What Will the Future Bring for Patents? - EC 2000 and further European harmonisation - Better tools for enforcement? Update on SPCs Competition Law and Exclusivity Rights - The sectoral investigation by DG Comp - The legal principles and policy considerations
	Event website
Contact	Mrs. Talana Bertschi
	E-mail
Further information	Details


17.11.08 - 19.11.08	BIO-Europe 2008
	m:con Congress Center Rosengarten Mannheim/Heidelberg, Germany
	The 14th annual BIO-Europe event is the world’s largest dedicated biotechnology partnering conference. Over 2,200 global decision-makers from biotechnology, pharma and finance annually attend BIO-Europe to identify new business opportunities and develop strategic relationships.
	Event website
Contact	Mr. Thomas Voigt
	E-mail


24.11.08 - 25.11.08	Regulatory Affairs Forum
	Le Meridien Hotel Munich , Bayerstrasse 41 80335 Munich , Germany
	• Scientific Advice and the Transatlantic Simplification Process • Centralised procedure: New market authorisation procedures and case studies • Update on Variation Regulations • Update on CMD(h) - Activities and the network • MRP / DCP procedures • Choice of RMS and availability of NCA resources • CMD(h) and CHMP referrals - interaction and case studies • Harmonisation of SmPCs of national MA's • The proposed new Pharmacovigilance Legislation • PSUR work-sharing and the link between PSURs and risk management plans • Transparency and public disclosure - Risk communication guideline - EudraCT and the impact of Paediatric Regulation • Risk management plans and Post Authorisation Safety Studies (PASS) • Risk management case studies • Telematics Roadmap and impact on regulatory business • Centralised procedure: eSubmission practicalities, Product Information Management (PIM) and case studies • NCA implementation of electronic initiatives: eCTD and NeeS
	Event website
Contact	Mrs. Talana Bertschi
	E-mail
Further information	Details


04.12.08 - 05.12.08	9th Conference on European Electronic Document Management
	Hilton Barcelona , Avenida Diagonal 589-591 08014 Barcelona , Spain
	During the past decades we dreamed, anticipated, waited for a future time when technology would shape a new landscape for EDM. Many of the components have been around for quite a long time. Others are just emerging. But now, for the first time, that future has come to being. EDM in many different shapes, spanning from home-grown systems to hosted repositories, has become the established method for managing official documentation. Registration dossiers are built electronically even for paper submissions and safety information is exchanged in electronic formats. Is this the end of the story? Certainly not but this much is certain: the future we dreamed of then, is now.
	Event website
Contact	Mrs. Talana Bertschi
	E-mail
Further information	Details


04.12.08 - 05.12.08	Cardiac Safety
	Hilton Barcelona, Avenida Diagonal 589-591 08014 Barcelona , Spain
	The rapid development of Cardiac Safety standards in clinical and drug development practices, coupled with the increased regulatory scrutiny, has resulted in a momentous evolution of the cardiac drug safety field. The ICH-E14 guidance has been at the centre of the public and industry interest since its inception in 2003. After its finalization in 2005, focus has shifted to regional interpretation and implementation of the guidance and the development of cardiac safety compliance strategies by biopharmaceutical and other organisations. The implementation of the E14 guidance has recently also been broadened to cover oncology drugs and biologics, with associated challenges in terms of e.g. finding alternatives to the ‘thorough QT study’ in healthy volunteers. Concomitantly, the field of Cardiac Drug Safety has expanded beyond the repolarisation and arrhythmia issues and is now involving wider areas of drug induced cardiotoxicity, including vascular and tissue related toxicities. These topics and other will be discussed at the forthcoming DIA Cardiac Safety meeting, alongside presentations of new technologies and novel biomarkers for early detection and risk management of drug related cardiac toxicity.
	Event website
Contact	Mrs. Talana Bertschi
	E-mail
Further information	Details


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