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Generics Event Diary

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4th EGA Pharmacovigilance Discussion Forum
24 January, London, UK: Come and learn directly from the key actors about the new EU pharmacovigilance legislation. Our forum will give you a unique opportunity to ask the right questions and get prepared for the future pharmacovigilance environment.

10th EGA Regulatory and Scientific Affairs Conference
25-26 January, London, UK: Join this year's 10th EGA Regulatory and Scientific Affairs Conference to get an update on recent developments and other important matters. Representatives from the authorities together with well-known experts will present the latest issues and share their point of view on different important topics.

Patent Term Adjustment and Patent Term Extension
26-27 January, Downtown Conference Center, New York : 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.

PIUG 2011 Biotechnology Meeting
9 February, South San Francisco, California : Branching out to the West Coast for its fifth annual meeting, the PIUG Biotechnology Meeting focuses on methodologies and resources for patent information professionals who specialize in biotechnology search and analysis. This year’s theme is: New Biologics: Proteins & Beyond.

The PHARM Connect Congress 2011
9-10 February, Eastern Europe: This event offers the perfect setting for solution providers to present their products and services directly to key decision makers of target client population throughout Central & Eastern Europe. Strictly operating on an invitation only basis guarantees that the highest level of delegation is present. Each solution provider at the PHARM Connect Congress is selected based on requirements and interests provided by attending Pharmaceutical professionals prior to the Congress event.

Structuring, Negotiating and Managing Life Sciences Collaborative Agreements and Acquisitions
16-17 February, New York, NY: to learn how to be able to secure the best terms available for meeting your company’s critical needs. A front line faculty of leading deal-makers including senior representatives from Merck, Abbott, Pfizer, Genentech, Eisai, Astellas, Novartis, Genzyme, and Biogen Idec will help you to develop a dynamic alliance strategy and negotiate successful and lucrative deals.

GPhA's 2011 Annual Meeting
16-18 February, Orlando, FLe: GPhA is honored to welcome FDA Commissioner, Dr. Margaret Hamburg as our 2011 Annual Meeting keynote speaker. The program agenda also includes addresses from top industry experts providing insight into the current and future business climate for the generic sector. Each year, more than 500 people attend this valuable meeting. Register today!

World Generic Medicines Congress Europe 2011
22-25 February, London, UK: World Generic Medicines Congress Europe 2011 addresses the health economics, pricing and competition pressures facing the generics sector in Europe and building scale and value through globalisation.

ITC Litigation & Enforcement
23-24 February, New York Marriott Downtown, New York: The accelerated nature of Section 337 investigations presents a myriad of procedural and litigation challenges for the experienced and novice counsel alike. As more and more companies turn to the International Trade Commission in pursuit of optimal remedies that can be delivered in an expedient timeframe, there is no question that the ITC has quickly become the forum of choice for litigating patent infringement suits.

EuroPLX 45 Lisbon
28 February - 1 March, Cascais/Lisbon, Portugal: As one of the industry's most international partnering events for business deals euroPLX features delegates from an average of 36 countries attending each event. You will only meet pharma and biopharma executives who are in charge of their companies' business development. euroPLX stands for for continuous, productive pharma partnering since 1995. Partnering scope: Registrants determine the "Dynamic Partnering Focus" of this event, displayed on www.europlx.com. It evolves and changes over time within a range from patented to generic (incl. biosimilars), from prescription to OTC drugs, companion diagnostics, nutraceuticals, and medical devices: development, licensing, marketing, promotion, and distribution.

Generics & Biosimilars Asia 2011
3- 4 March, Amara Hotel, Singapore: With strong demand for affordable healthcare throughout Asia, governments are favoring production and prescription of generics and biosimilars. Generics & Biosimilars Asia 2011 is set to address many of the pressing issues faced by both innovator and generic drug companies. Network and learn from peers facing similar challenges in market access, drug pricing and reimbursement in the evolving pharmaceutical industry in Asia. www.genericsbiosimilarsasia.com.

IPI-ConfEx 2011
6 March, Sevilla, Spain: The 8th annual conference will feature a strong programme and is the ideal forum for continuing education, professional development, networking, and the sharing and benchmarking of best practice in the patent information industry.

7th EGA Legal Affairs Forum with an Opening Session on SPCs
17-18 March, Renaissance Hotel, Brussels, Belgium: The sessions will focus on:
- Recent developments on SPCs: a case-study approach
- Patent application strategies and competition law: Astra Zeneca case/Duty of candour and dominant operators/Patent settlements
- Patent enforcement in Europe
- Improvement of patent quality, granting and opposition procedures at the European Patent Office

Pharma Partnering and Investment World Asia 2011
29-30 March, Marina Bay Sands, Singapore: Bringing together biotechs, pharmas, healthcare services, medical solution providers, academic research institutions, and investors from around the world to gather and discuss strategic investment, licensing and partnering opportunities.

INTERPHEX 2011
29-31 March, Javits Convention Center, New York City: Thousands of pharmaceutical, biologic, generic, and contract services professionals gather annually at INTERPHEX to see new products, network, and learn about emerging trends surrounding drug manufacturing. At INTERPHEX 2011, you’ll find the solutions and education you need to ensure quality, improve efficiency, and solve your manufacturing and supply chain problems. Register for a free exhibit hall pass at www.interphex.com.

6th Summit on Biosimilars and Follow-on Biologics
30-31 March, The Westin Tysons Corner, Falls Church, VA: Join leaders from brand and biosimilars companies to explore the current climate for biosimilars business including evaluation of the U.S. and ex-U.S. market landscape, reimbursement considerations, clinical development and views on interchangeability.

9th EGA International Symposium
14-15 April, London, UK: Join the 9th EGA International Symposium to get an update on recent developments and other important matters. Representatives from the authorities together with well-known experts will present the latest issues and share their point of view on different important topics.

NextGen 2011 – Super-Generics Strategies India
27-29 April, Mumbai, India: The 2nd Annual NextGen 2011: Super-Generics Strategies India will bring together 200+ senior-level R&D, Commercial, Strategy and Regulatory decision-makers from across the Indian pharmaceutical landscape. Over three intensive days, you’ll have the chance to learn about the super-generics challenges facing the Indian pharmaceutical industry and take advantage of key networking and business development opportunities to help you to get the edge in an increasingly competitive global pharmaceutical industry.

5th Paragraph IV Disputes
03-04 May, New York City, USA: This event is the single forum on which brand name and generic companies can rely for answers during this turbulent time in which the balance of power designed by the Hatch-Waxman Act may completely unravel. Come to this conference and get the up-to-the minute information that you need to prepare for the new litigation confrontations to come.
In this costly and ruthless endgame, not a moment can be lost. Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563 or logging on to www.AmericanConference.com/ParagraphIVDisputesNYC

GPhA/FDA Quality by Design Conference for ANDAs
May 5-6, North Bethesda, MD: Join us for this two day interactive workshop devoted to the understanding of Modified Release Quality by Design concepts for ANDAs. This workshop will address review a QbD MR case study and each core component of Quality by Design for Modified Release dosage forms. The conference will provide advice to industry on how to satisfactorily meet these expectations. Don’t miss this unique opportunity to understand the soon to be required QbD information that the Office of Generic Drugs (OGD) expects to be included in ANDAs. Register Today!

Generics, Super-Generics, and Patent Strategies
11-12 May, London, UK: SMi's conference aims to provide an insight into the complexity of the current commercial and legal landscapes surrounding the Generics marketplace, and to keep you up-to-date with future trends and developments. Also running are two pre-conference workshops on Tuesday 10th May 2011. Valsartan: Negotiating the EU patent thicket for a blockbuster anti-hypertensive Generics in the emerging markets: Boom or bubble? For more information please visit: www.smi-online.co.uk/2011generics8.asp

EuroPLX 46
30-31 May, Vienna, Austria: euroPLX Meetings are the place for pharma deals, attended by industry executives in charge of business development, commercial operations, marketing, and brokers or consultants with clear mandates. euroPLX delivers an average of more than 23 pre-scheduled appointments per participating company.

GPhA/FDA ANDA Labeling/ DDMAC Workshop
1-2 June, Bethesda, MD: Don’t miss this unique opportunity to hear directly from FDA’s Office of Generic Drugs (OGD) Labeling Review Staff responsible for reviewing and approving your applications during a full 1 day workshop. Also as a bonus you will be able to hear the latest directly from the Division of Drug Marketing, Advertising and Communications (DDMAC) during a half day workshop which will focus on drug advertising issues that are specific to the generic industry. Click here to register.

17th EGA Annual Conference
15-17 June, Lisbon/Cascais, Portugal: 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!

10th Annual International Pharma Patent Lyfecycles
21-22 June, London, United Kingdom: The 2011 Pharma Patent Lifecycles Forum will focus on recent cases across Europe and the US and their impact on the latest regulatory developments and strategies for patent lifecycle extensions.

Pharmaceutical Portfolio & Product Life Cycle Management
29-30 June, Holiday Inn Bloomsbury, United Kingdom: Join SMi at their 6th annual Pharmaceutical Portfolio & Product Life-Cycle Management conference where you will: - Discuss other’s approaches to fully integrated portfolio and PLCM management - Learn of the latest EU patent regulatory guidance - Analyse the most effective risk mitigation strategies - Debate the merits and drawbacks of portfolio out licensing - Network with established managers and directors who have developed successful portfolio and product life-cycle strategies

"How to identify key IP protection" Webinar
19 July, your office!: This webinar will demonstrate some techniques for identifying ‘key’ patent protection of established pharmaceutical products. Faced with many different ‘expiry dates’ for a given pharmaceutical product, it is often a complicated task to determine whether the date will constrain generic competition completely or only for certain product lines or indications. Often the most complex molecules to establish key patent protection for are biologics, which can be protected by many ‘platform’ patents held by numerous patentees.

Tonkin's 2nd Annual Pharmaceutical Law Conference
18-19 July, Sydney, Australia: Examine “undue influence in the pharmaceutical industry”. Uncover untapped market potential relating to Biosimiliars. Update your knowledge with exclusive regulatory reviews. Understand the true ramifications of Paterson v Merck, Sharpe & Dohme (Aust) Pty Ltd [2010] FCA180. Create effective anti-counterfeiting strategies to protect your most valuable assets.

4th Annual Product & Pipeline Enhancement for Generic Conference
27-28 July, Falls Church, VA: EAttending this premier conference will give you the chance to gain critical knowledge on innovative opportunities in the generics industry. The expert speaker line-up will allow discussion on major industry challenges and how they met them head on with new product pipelines and processes as well as robust intellectual property and patent strategies. The purpose of this event is to provide proficient framework for market sustainability and success in the future generic pharmaceutical market.

4th Annual Pharmaceutical Law Asia 2011
12-14 September, Grand Copthorne Waterfront Hotel, Singapore: Running for the 4th year now, this year we’ll be bringing you different case studies and topics you can share with your organization. Thoroughly researched from amongst your peers within the industry, we bring you sessions that focuses on IP Strategies to extend the life cycle management, defend and gain market share in Asia’s pharmerging markets and many more. Visit www.pharmalawasia.com for full list of speakers, agenda and registration details

2011 Pharma CI Conference
13-14 September, Parsippany, New Jersey, USA: The Pharma CI Conference & Exhibition is THE INDUSTRY'S GOLD STANDARD for senior level pharmaceutical, biotechnology, medical device, and diagnostics professionals seeking the latest news and networking with all the industry's luminaries. More than 300 people came in 2010! This is the biggest and best gathering of pharmaceutical competitive intelligence thought leaders. For more information about the all-star participants, go to www.pharmaciconference.com

2nd Annual Bioequivalence and Bioavailability Studies
19-21 September, Four Points by Sheraton, Brussels, Belgium: Pharma IQ’s 2nd Annual Bioequivalence and Bioavailability Studies conference will highlight the challenges and successes of the 2010 EMA guidelines, outline effective strategies for ensuring compliance, provide practical case studies on optimising study design, increasing biowaiver success rate to speed time to market and decrease costs as well as providing in-depth insights into the future challenges of modified release products.

3rd Annual Business of Biosimilars & Biobetters
19-21 September, Boston, USA: This year, The Business of Biosimilars event is expanding to the Business of Biosimilars and Biobetters in order to better address the needs of our audience and reflect the changes in the biopharmaceutical industry. Due to the lack of regulatory guidance within the US and the ongoing debate about the anticipated value of commercializing biosimilars in the US and abroad, we have decided to expand the scope of our meeting to enable pharmaceutical and biotech companies to discover global biosimilar and biobetter commercialization opportunities through in depth analysis of scientific and business development considerations.

Global Generic Strategy Summit
20-21 September, Berlin, Germany: 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.

Biosimilars & Biobetters
26-27 September, Copthorne Tara Hotel London, UK: SMi is pleased to invite you to their 2nd annual Biosimilars & Biobetters conference that will be presented by leading industry figures and stakeholders. Key Topics Addressed:
• The developing regulatory framework in advanced and developing markets
• The specific commercial, legal and scientific development of monoclonal antibodies
• Differentiated biosimilars: Debating their true value and potential
• Critical issues in demonstrating biosimilarity and maintaining diligent quality control
• Opportunities to drive a long term commercial strategy
• Specific Biosimilars case studies from different stakeholder perspectives

GPhA/FDA Fall Technical Conference
October 3-5, North Bethesda, MD: GPhA is pleased to announce that registration is now open for the GPhA/FDA Fall Technical Conference. Come learn and listen to top FDA officials who make up the speaking faculty at this premier generic industry science and regulatory meeting. The Fall Technical Conference now attracts more than 600 industry professionals. Also register for the pre-conference Project Manager Workshop on October 3, where OGD project managers and industry attendees exchange information on communications between OGD and industry as well as best practices for industry as it relates to ANDAs. Space is limited, early registration is recommended. Register Today!

12th Annual Maximizing Pharmaceutical Patent Life Cycles1
4-5 October, New York, US: American conference Institute’s (ACI’s) Maximizing Pharmaceutical Patent Life Cycles conference is the pharmaceutical industry’s leading source for information and analysis on patent life cycle management for both small and now, large molecule pharmaceutical products. It is the forum where lawyers, executives and policy makers for brand name and generic manufacturers gather each year to prepare for the life cycle challenges they currently face as well as those which they anticipate.
Don’t delay – register now by calling 888-224-2480.

21st Annual Biotech Patenting
October 5-6, London, UK: The 2011 London Biotech Patenting forum will focus on latest legal developments affecting biotech companies and how to implement successful methods and strategies for drafting and filing patent applications in multiple jurisdictions. The event will provide you with the opportunity to network with your peers, key industry regulators and expert patent attorneys from across Europe, US, India and China to allow you to benchmark your current biotech practices and remain competitive.
Register now using the code "GW 100" to save 100 pounds off the current conference price.

7th Annual Developing IP Strategies for Crystalline Forms
24-26 October, London, UK: Pharma IQ's 7th Annual Developing IP Strategies for Crystalline Forms, taking place 24-26 October in London, is the only event of its kind that will directly address the unique challenges involved in patenting crystalline forms. It will provide practical solutions to the most common problems in patent application and expert insights into successful litigation strategies. Confirmed speakers include representatives from: Novarti,s Actelion, Ipsen, Intellectual Property Office, USPTO, Novozymes, Merck, Valea AB and many others.

CPhI Worldwide
25-27 October, Frankfurt, Germany: CPhI Worldwide - the focal point for the global pharmaceutical industry - is once again in Frankfurt for the 2011 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.
GenericsWeb can be found at stand 42K57.

6th Annual Generics Asia 2011
31 October - 01 November, Sheraton Towers, Singapore: This event has been thoroughly researched to reflect critical regional concerns and provide a forum to learn the latest in the generics industry. Meet industry headline-makers and game-changers to discuss strategies, supergenerics, differentiated generics, branding, partnerships and opportunities in pharmerging markets with new and incumbent stakeholders including Sanofi-Aventis, Pharmex Japan, Wockhardt, Pfizer, Getz Pharma, Pharmaniaga and many more! Visit www.generics-asia.com for full list of speakers, agenda and registration details.

14th Annual IGPA Conference
1-3 November, Cape Town, South Africa:The 14th Annual IGPA Conference, being held in Africa for the first time, is organised by the world’s leading generic medicines industry associations (CGPA, EGA, GPhA, IPA, JGA and NAPM) to give you the very latest insight into the commercial, regulatory and legal developments related to the global generic pharmaceutical sector.
Speakers include top-level experts from the scientific, regulatory, intellectual property and commercial fields of great importance to pharmaceuticals and creating the optimum business environment.

World Generic Medicines Congress Americas 2011
15-17 November, Washington, US: The World Generic Medicines Congress Americas 2011 is now in its fourth year and is regarded as the meeting of choice for leading generic experts striving for excellence in their industry. The conference bridges the gap between international generic manufacturers, pharmaceutical manufacturers, regulatory bodies, policy decision makers and financial organisations. It provides a forum that focuses on the key topics of the day, with input from the industry's most innovative minds.

14th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients
16-18 November, Munich, Germany: After the several Regulatory topics presented during Day Two of the conference, the RA conference will highlight the current workplan of the EMA Quality Working Party and EDQM’s update of its activities with regard to the CEP procedure, including its API inspection programme. In addition a special topic on the impact of patent expiry on regulatory assessments will be discussed. This is followed by an update on regulatory guidance on APIs for the Brazilian market. The Conference is rounded off by an evaluation of the new EU Variations Regulation.

euroPLX 47 Geneva
21-22 November, Geneva, Switzerland: one of the industry's most international partnering events for business deals euroPLX features delegates from an average of 36 countries attending each event. You will only meet pharma and biopharma executives who are in charge of their companies' business development. euroPLX stands for continuous, productive pharma partnering since 1995.
Partnering scope: Registrants determine the "Dynamic Partnering Focus" of this event, displayed on www.europlx.com. It evolves and changes over time within a range from patented to generic (incl. biosimilars), from prescription to OTC drugs, companion diagnostics, nutraceuticals, and medical devices: development, licensing, marketing, promotion, and distribution.

Pharma IP strategy
8 December, London, UK:We are excited that our Masterclass will be delivered through a combination of diversely skilled speakers who will give presentations, case studies and discussions. This is designed to help inspire delegates with an understanding of and a synergistic approach for successful drug development.

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