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2010:
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3rd EGA Pharmacovigilance Discussion Forum
20 January, London: Speakers include Suzette Kox, EGA; Ilaria Passarani, BEUC; Gernot Schreiber, Sandoz International. Topics covered include cutting red tape while insuring safety, latest developments, and the generic industry's perspective.
9th EGA Regulatory and Scientific Affairs Conference
21-22 January, London: 'Focus on the Future'- Speakers include Greg Perry, EGA; Caroline Kleinjan, Sandoz; Tom Manussen, Disphar; Harm Peters; Tiefenbacher. Topics include the electronic submission environment, and regulatory implications of various changes in the legal and operational environment.
9th Annual Project and Portfolio Management for Pharma 28-29 January, Barcelona: Growing Your Business and Maximising ROI and with Effective Project and Portfolio Optimisation in a Resource Constrained Environment. Project and portfolio remain a critical area for a company’s success. With the growing competition, limited resources and increasingly challenging economic landscape, pharmaceutical companies are under increased pressure to deliver additional value, maximise their portfolios and grow the business. Only companies with the right strategy and comprehensive portfolios will have the competitive edge.
Pharmaceutical Regulatory Affairs in the Middle East
4-5 February, London: Including Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen.
GPhA 2010 Annual Meeting
16 - 18 February, Florida: Join us for the premier meeting for the U.S. generic pharmaceutical industry. More than 500 top industry executives and stakeholders convene in Naples, Florida for perspective on the most important emerging issues facing the generic pharmaceutical sector. The program agenda includes addresses by industry CEOs along with broad plenary session presentations that provide valuable insight into the current and future business climate for the manufacture and sale of generic medicines. GPhA is honored to welcome FDA Commissioner, Dr. Margaret Hamburg as our 2010 Annual Meeting keynote speaker.
4th Annual World Generic Medicines Congress Europe 2010
23-26 February, London: The World's leading generic medicines strategy conference. The 2009 speaker panel included representation from; Teva Europe, Polpharma, Hospira, Actavis, Torrent Pharma, Sandoz, Dr Reddy’s, the Beijing Pharmaceutical Group and Insmed.
5th Annual Global Pharma SFE Forum
24-25 Feruary, Madrid: Improving sales effectiveness is not just a sales function issue. Success is the result of collaboration between HR, Training & Development, Marketing and CRM departments. To help you to understand drivers of continuous improvement of knowledge, we are proud to present a 5th Annual Global SFE Forum.
6th EGA Legal Affairs Forum
11 March, Munich: Details coming soon.
4th Annual Biosimilars Conference
16 -17 March, Brussels: In the last couple of years we have seen many developments with biosimilar medicines. The ever-changing landscape proves that it’s increasingly imperative for you to be aware of the new regulatory changes and understand fully how to deal with post-launch issues. At the 4th Annual Biosimilars Conference you will learn how to launch and market a biosimilar successfully and what pharmacovigilance plans need to be in place to mitigate the risks of adverse events.
FDA Boot Camp
24-25 March, New York: ACI’s FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies. A “Who’s Who of the FDA Bar” will share their knowledge and give you critical insights on FDA regulatory essentials. Register now by calling 888-224-2480 or logging onto www.americanconference.com/FDABootCampNYC.
GPhA 2010 ANDA Labeling Workshop 14-15 April, North Bethesda: This workshop is designed to provide industry with current information on the ANDA labeling review process as well as the many issues now facing the generic industry when submitting ANDA labeling.
7th Controlled Release Conference
28-29 April, London: The controlled release of a pharmaceutical active can be a vital tool in ensuring the safety and efficacy of a new or existing treatment. Developing new methods of controlled release is important to prolong the duration of action, can help to minimise adverse reactions and maximise efficacy as well as being an effective way of increasing a drug's lifespan. SMi's 7th Controlled Release conference will provide you with the latest updates in this area, including controlled release development strategies, practical issues in developing controlled release therapeutics and information on the latest advances in delivery methods.
 Biosimilar Medicines: 8th EGA Annual International Symposium22-23 April, London: The EGA annual international symposium on biosimilar medicines will explore the latest legal developments in the US, EU market inroads, health economic perspectives, clinical and market experience as well as EU and international regulatory developments. There will be a special focus on the imminent draft guidelines on biosimilar monoclonal antibodies and immunogenicity assessment of all monoclonal antibodies.
 GPhA/FDA 2010 QbD Conference 4-5 May, North Bethesda: The Generic Pharmaceutical Association (GPhA), in partnership with the U.S. Food and Drug Administration, is hosting the first two-day workshop devoted solely for the purpose of fostering in-depth agency/ industry discussion on Quality by Design for ANDAs. MORE THAN 75 FDA SPEAKERS AND ATTENDEES have registered for this event, underscoring the Agency’s commitment to this critical, emerging paradigm. Don’t miss this one-of-a-kind opportunity to network with the FDA staff responsible for reviewing your applications while acquiring an understanding of this important new standard.
 Generics, Super-Generics and Patent Strategies
10-11 May, London: The worldwide generics industry has seen strong growth in recent times as the demand for affordable treatment has increased worldwide. In addition to this, numerous branded-drug patent expirations, the prospect of generic biotechnology drugs and a favourable regulatory environment is providing a huge opportunity for the sector to expand further. Attend this conference to discover the future of the generics market. Hear experts in the field discuss the latest patent strategies, regulatory updates and growth strategies that will be key to the future of the industry.
 5th Annual Licensing in Generics11-12 May, Vienna: Leading generics players understand, how to establish and maintain partnerships, that will strengthen their position in key markets. Reveal, how to make licensing and partnering a key strategy to achieve a profitable growth. Utilise the market opportunities for biosimilars, understand, what are top selling products and expected expiry dates. Leading generics companies will share their first hand experience, how they tackle pricing, regulatory and IP challenges to ensure success of their business development strategy.
PharmaVenue Meeting
17-18 May, Madrid: PharmaVenue brings together executives from around 30 countries including CEOs, Senior Executives in Business Development, Licensing, R&D as well as Directors of Marketing and Sales.
GPhA/FDA 2010 ANDA Basics Workshop
2-3 June, North Bethesda, MD: This two-day workshop addresses the fundamentals of preparing and submitting abbreviated new drug applications. Learn directly from FDA’s Office of Generic Drugs (OGD) staff members who are responsible for reviewing and approving your company’s applications. OGD and industry expert instructors will focus on each of the critical sections of an ANDA, including regulatory, labeling, chemistry, manufacturing and controls, and bioequivalence. The industry experts also will share 'real world' experience related to the preparation and submission of ANDAs.
 16th EGA Annual Conference
2-4 June, Rome: Join your colleagues to gain the latest information on the most important emerging issues facing the generic pharmaceutical industry. Each year, attendees from all over the world gather at the EGA Annual Meeting to learn about the latest developments within the industry but also to network with colleagues at the different formal and informal events!
EuroPLX 43 Berlin14-14 June, Berlin: International partnering forum for Bio/Pharma Business Development & Licensing Executives seeking deals in patented and generic (incl. biosimilars), prescription and OTC Drugs, nutraceuticals, and medical devices: development, licensing, marketing, promotion, and distribution. The actual focus is determined by the participating companies' business interests, displayed as "Dynamic Partnering Focus" on www.europlx.com.
Follow-on Biologics
21-22 June, : This hands-on session will provide you with practical advice, as well as tips and techniques for how to extend your patent. The session leader will take you through the intricacies of the major ways of getting an extension on your patent, and provide you with the tools that you need to accomplish this goal in this time of changing rules and regulations. Register now logging online or by calling 888-224-2480.
Maximising Pharmaceutical Patent Life Cycles
23-24 June, The Helmsley Park Lane Hotel, New York, NY: This hands-on session will provide you with practical advice, as well as tips and techniques for how to extend your patent. The session leader will take you through the intricacies of the major ways of getting an extension on your patent, and provide you with the tools that you need to accomplish this goal in this time of changing rules and regulations. online at www.C5-Online.com/pple
 Pharmaceutical Portfolio & Product Life Cycle Management
28-29 June, London: Developing promising portfolios into a profitable revenue stream in such a highly regulated and resource limited environment is a challenging undertaking. It is therefore essential to understand how to build an optimal mix of innovative projects within a portfolio, introduce them quickly and manage them effectively and efficiently. This Conference will provide an unmissable learning and networking opportunity with the leading experts from the world of Portfolio and Life Cycle Management.
 The Life Sciences Lawyer's Guide to PTA and PTE
18-19 August, New York, NY: ACI has designed this two day intensive program to help you master the skills you need to face your greatest PTA and PTE challenges head on. A faculty of PTA and PTE experts will offer practical solutions and in-depth instruction for everything from eligibility requirements to calculation to the application and reconsideration processes to the interplay of these mechanisms. Register now logging online or by calling 888-224-2480.
FDA Boot Camp25-26 August, San Francisco, CA: ACI’s FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies. A “Who’s Who of the FDA Bar” will share their knowledge and give you critical insights on FDA regulatory essentials. Register now logging online or by calling 888-224-2480.
Global Generic Strategy Summit14-16 September, Barcelona: Innovator companies will lose patent protection on their largest or second-largest products will reach a crescendo around 2011/2012. Are you taking advantage of these crucial opportunities? Do not miss out on the chance to hear strategies from 10 CEOs, Presidents and Managing Directors from top generics companies on how they will be seizing the latest generics opportunities.
 IRR's 2nd Annual Business of Biosimilars20-22 September, Boston: This conference delivers effective strategies to navigate scientific, regulatory, economic, and legal challenges you face to remain competitive in commercializing your biosimilar portfolio in the United States and abroad. No other event gives you 3 full days including one full day seminar on Strategies to Expedite Approval of Your Follow-On Biologic: From Drug Discovery to Post Approval, a dinner workshop on IP Protection and Patent Litigation, 30 expert faculty members including representatives from FTC, Sandoz, Takeda, Sanofi-Aventis and much more. Register today and receive 25% off the standard registration rates! Mention VIP code XP1586GWEN.
Pharma CI Conference & Exhibition 201021-22 September, New Jersey: The Pharma CI Conference & Exhibition is the best and largest gathering of pharmaceutical competitive intelligence professionals! This is the industry's gold standard for senior level pharma, biotech, and medical device professionals who are seeking the latest in competitive intelligence/ business intelligence. The Pharma CI Conference will be held September 21-22, 2010 at the Hilton Parsippany Hotel, New Jersey. For more information, please visit www.pharmaciconference.com
Biosimilars & Biobetters
22-23 September, London: SMi is proud to present our inaugural Biosimilars & Biobetters: Aligning Business & Science for Success. Biosimilars are seen by some as the new generic frontier; hear experts in this field discuss the latest developments in legislation, regulation, technology and emerging commercial strategies to succeed in this highly competitive market. Key topics include: The developing US follow-on biologics framework, the challenges in biosimilar commercialisation and how biobetters fit into a long term commercial strategy.
A Year in Patents28 September, London: Attendees will gain insights regarding a number of key cases on topics such as selection inventions, obviousness, claim construction and patentability. We will also consider developments in patent litigation relating to such practical issues as unjustified threats, injunctions and financial relief.
CPhI Worldwide5-7 October, Paris: CPhI Worldwide - the focal point for the global pharmaceutical industry - is once again in Paris for the 2010 event; a unique and unrivalled gathering for commercial and networking opportunities that enables manufacturers, suppliers, buyers and users to exchange ideas, form alliances and do business on an international scale.
Generics R&D and Partnering Asia 2010
13-15 October, Shangai: The project fair in the summit surely provide you with a desirable platform of seeking right business partners : R&D outsourcing between pharmaceutical companies and cros, Technology transfer between pharmaceutical companies, laboratory equipments, life science solution and others among pharmaceutical companies, cros and other suppliers .
5th Summit on Biosimilars and Follow-On Biologics18-19 October, Washington, DC: This conference is for professionals in the biotech and pharmaceutical industry who are involved with or in the process of developing follow-on biologic products.
GPhA 2010 Fall Technical Conference19-21 October, North Bethesda, MD: This educational conference is the premier science and regulatory meeting for the U.S. generic pharmaceutical industry. More than a dozen top, U.S. Food and Drug Administration officials present the latest information on key, current regulatory and technical issues. Attendees have the unique opportunity to learn directly from staff members at the Office of Generic Drugs and meet them at the many networking opportunities throughout the event. Attend pre-conference workshops on October 19 followed by plenary sessions October 20-21. Note: Preferred hotel rates may sell out. Register today.
Bioequivalence and Bioavailability Studies Conference
26 - 27 October, Munich: The Bioequivalence and Bioavailability studies conference will provide you with a key platform to discuss and find out how others are tackling the main challenges faced in the bioequivalence field, as well as taking the opportunity to network with your peers and forge new contacts in this area.
13th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients27 - 29 October, Barcelona: The APIC/CEFIC Conference on Active Pharmaceutical Ingredients is Europe’s leading event. Many major stakeholders from Authorities and the Industry are each year joining this Conference. Speakers from FDA, European Commission, EMA, EDQM, WHO, USP, National Authorities and from Industry will discuss the latest developments in the field of GMP and Regulatory Compliance.
EuroPLX 44 Barcelona 8 - 9 November, Barcelona: International partnering forum for Bio/Pharma Business Development & Licensing Executives seeking deals in patented and generic (including biosimilars), prescription and OTC Drugs, nutraceuticals, and medical devices: development, licensing, marketing, promotion, and distribution. The actual focus is determined by the participating companies' business interests, displayed as "Dynamic Partnering Focus" on www.europlx.com.
World Generic Medecines Congress Americas 2010
16-19 November, Washington: World Generic Medicines Congress Americas 2010 addresses the health economics, pricing and competition pressures facing the generics sector in Americas and building scale and value through globalisation.
13th Annual IGPA Conference 8-10 December, Mumbai: The Conference provides a unique opportunity of networking with senior management of the global companies and discusses key issues of the generic industry. It offers valuable insights into the intellectual property related matters and regulatory developments in the world and highlights market opportunities and challenges.
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