Pharmaceutical Outsourcing: A Russell Publishing Publication

Event Venue: TBC City & Country to be held: Frankfurt, Germany This is the event focusing on both upstream and downstream processing for biological manufacturing, production and cGMP specialists. Over the course of this 3 day event, you will take part in a mixture of networking and conference session featuring the latest strategies and industry case studies. Included in the event this year is the opportunity to take part in a tour at Merck KGaA’s head quarters. It is a unique day which will give delegates the chance to be one of the first to tour their brand new Process Solutions and also learn about the latest advancements taking place there.

The Event Dedicated to Drug Manufacturing Excellence. Hosting leading industry professionals, this Pharma Manufacturing event provides a unique opportunity to hear the latest trends in drug manufacturing and network with leading industry peers. Why attend: *Innovating and streamlining manufacturing processes, while adhering to evermore and regulatory standards is one of the biggest challenges for the drug manufacturing industry today. *To improve efficiency, reduce costs, accelerate time to market and maximize profits in today’s rapidly changing business environment, pharmaceutical companies need to exploit new strategies, technologies and practices. *Hosting leading industry professionals, this Pharma Manufacturing event provides a unique opportunity to hear the latest trends in drug manufacturing and network with leading industry peers

Venue: CCT at Smithfield, London Description: Developing an in-house strategy for PAT and QbD application specifically for biopharmaceutical products Pharma IQ is delighted to announce the inaugural PAT and Quality by Design for Biopharmaceuticals, being held in London on the 25th-26th May 2010. With PAT and Quality by Design techniques now established within the small molecules field the focus is shifting to application within the biopharmaceuticals arena, with key regulatory bodies such as the FDA and EMEA actively getting involved I pilot case studies. This event will bring together professionals specifically tasked with implementing PAT and QbD tools and techniques specifically within the Bioprocess and Bioproduction area. Agenda  Design space validation for a Bio Products: Establishing a step by step design and validations process  Process monitoring tools and applications: How to successfully manipulate NIR for large molecule assessment  Risk assessment and risk control modelling in QbD –  Setting Critical Quality Attributes (CQA) for biopharmaceutical products: Highlighting the challenges and how to overcome them –  Understanding the importance of using multi-variate data analysis for Biopharmaceutical QbD support – in-line and on-line monitoring  Using PAT and QbD to aid scale-up: How can QbD actually help facilitate scale up?  Understanding the regulations surrounding PAT and QbD application for Biopharmaceuticals and the application in ICH Q8-10  Advantages of QbD approach for biological products: Can this truly help with quality prediction? (Subject to change) Tel: +44 207 368 9300 Email: enquire@iqpc.co.uk

SBS Biopharmaceuticals Symposium: Exploring Synergies Across Drug Formats May 20 – 21, 2010 San Francisco Hilton Union Square San Francisco, California, USA www.sbsonline.org/biopharmaceuticals Biopharmaceuticals is a rapidly growing sector of the pharmaceuticals industry. Join us for this two-day program, featuring top-notch sessions and keynote presentations. Poster presentations, an exhibit hall and a networking reception make this SBS Symposium a powerful resource.

Biopharmaceuticals is a rapidly growing sector of the pharmaceuticals industry. Join us for this two-day program, featuring top-notch sessions and keynote presentations. Poster presentations, an exhibit hall and a networking reception make this SBS Symposium a powerful resource.

With the oncology market now valued at $55 billion, pharmaceuticals and biotech manufacturers are under pressure to find innovative ways of speeding development times in order to claim their share of this lucrative area. However, oncology poses unique patient recruitment, trial design and operational challenges – issues that can waste invaluable resource and slow regulatory approval. Through a series of interactive presentations and discussions, Pharma IQ’s Optimising Clinical Development in Oncology conference provides a unique platform for manufacturers to discuss practical, proven ideas to save time and money and ensure that companies have the knowledge they need to take their drugs to market fast. This is the must-attend event for all clinical operations and clinical research executives in oncology practices and will feature industry-led keynotes, interactive panels, workshops, and a key emphasis on networking. Why do you need to attend Optimising Clinical Development in Oncology? • You will hear proven processes to overcome strategic and operational challenges to reduce costs and timelines during oncology trials • You will learn how to improve your patient selection and retention strategies through a better understanding of trial goals and ideal patient populations • You will participate in expert led interactive roundtable discussions to provide you with practical tools to ensure that your trials run smoothly • You will get ideas on clinical trial partner selection and vendor management processes to maximize the return on your outsourcing investment • You’ll learn how to improve your long-term outsourcing strategies to overcome clinical trial challenges in the current economic climate • You’ll be able to take away ideas on managing the transition from early to late phase trials to ensure that your studies remain on target to achieve their goals • You will hear about how your peers develop more robust processes for data capture and analysis to facilitate the use of adaptive trial models • You will learn how to make the best use of biomarkers and imaging throughout your trial to better understand patient outcomes Tel: +44 207 368 9300 Email: enquire@iqpc.co.uk

In this Process Validation learn how to validate a manufacturing process and do it in a reasonable time. Why Should You Attend: Every pharmaceutical manufacturing process is a batch process that consists of discrete steps and which require specific equipment and its operation in specific manner for a specific length of time. US Federal Regulations require validation of the manufacturing process for each product sold. Validation consists of establishing which operating parameters are critical to the success of the process and the precise range of operations that will assure consistent and reproducible product quality every time. Many papers have been written about this subject. Unfortunately, most of these publications are overly complex and serve to confuse more than to be helpful. As one of the few people who were there at the inception of the validation requirement and who served on a Pharmaceutical Manufacturers Association validation advisory committee, this speaker has not only validated processes around the world, but was there when the validation concepts were developed and methodologies were negotiated with FDA. In this webinar, you will learn not only how to validate a manufacturing process, but how to do so in a reasonable period of time. Note:Discount available for 10% Please Contact us on (+1-650-620-3915).

The EurasiaBIO Partnering Congress&EXPO is the global event for Biotechnology and Renewable Energy in Russia and CIS countries. The Congress is hosted by the Yu.A. Ovchynnikov Russian Biologists Society. Online partnering system is provided by EBD Group. The event offers an unparalleled opportunity for biotechnology, pharmaceutical and energy companies, academic research institutions, and investors from around the world to gather in one place at one time to learn about each other, meet one-on-one, and discuss business opportunities of mutual interest. The EurasiaBIO is supported by: The State Duma of the Russian Federation Ministry of Industry and Energetics of the Russian Federation Ministry of Agriculture of the Russian Federation Russian Academy of Sciences Russian Academy of Agricultural Sciences European Federation of Biotechnology European Commission Research DG

During this five-day event, more than 2,000 eminent scientists, innovators, researchers and industry analysts from around the world will converge in Phoenix for the Annual SBS Conference & Exhibition to learn about the latest trends and basic and applied research that are dramatically transforming the way new pharmaceuticals are developed.

Partnerships with CROs is now known as Partnerships in Clinical Trials. After almost twenty years, the industry and the event have experienced tremendous growth as outsourcing to CROs and other clinical outsourcing providers has become more than a strategy to control costs and expedite clinical trials but literally THE strategy for ensuring value and qualityin complex clinical trials. The new title better reflects the comprehensive nature of the program, which is the must attend annual event for clinical outsourcing and development professionals and is increasingly valuable to those with responsibilities in clinical operations, drug safety and quality. Partnerships in Clinical Trials continues to be the leading global event serving the educational and business needs of pharmaceutical, biotech and medical device executives in the US.

In this GMP auditor training for pharmaceutical companies you will learn what a GMP auditor should do and how to conduct an audit. An overview of various GMP regulations and discussion on most commonly cited GMP violations and how to find and correct it. Why Should You Attend: Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal GMP audits in order to find and correct areas where the firm is not in full compliance with the GMP regulations before an FDA audit occurs. There are several problems with this approach, however. The auditors may not fully understand the regulations and may not have been trained in audit techniques. Another impediment is that an internal auditor is monitoring his/her friends. It is very difficult to point out errors committed by a friend since by calling attention to a lack of compliance may be interpreted as "telling on" the friend and possibly causing a problem for them. Note:Discount available for 10% Please Contact us on (+1-650-620-3915).

IQPC's 4th Annual Improving Solubility conference provides new solutions to measure, predict and improve solubility, ultimately maximizing time-to-market. Topics include applying lipid based formulations, overcoming physical instability, new drug delivery technologies, identifying in-vitro absorption and discovering formulations for toxicology studies.

Event Name: BioPharma Asia Convention 2010 Date: 16-19 March 2010 Venue: Raffles City Convention Centre Country: Singapore Organizer: Terrapinn Pte Ltd. Event Email: esther.chan@terrapinn.com Event Website: http://www.terrapinn.com/2010/biopharmaasia/ Description: BioPharma Asia Convention 2010 is uniquely positioned as Asia's only exhibition that showcases leading technocrats, solution and service suppliers across the entire value chain of the biopharma industry in Asia. It combines 6 conferences in 1, which consists of BioPharma CEO Roundtable, “World Pharma Trials Asia”, “Biologic Manufacturing World Asia”, “Pharma R&D Partnering World Asia”, “Drug Discovery Technology World Asia” and “Pharma & Biotech Supply Chain Asia”. World Pharma Trials Asia 2010 World Pharma Trials Asia is an event convening pharmas, biotechs, and CROs to explore offshoring & outsourcing opportunities in Asia for cost effective preclinical and clinical drug development, at a time where Asia’s CRO market is growing at a doubling rate yearly, with more and more global pharma and biotechs are offshoring and outsourcing their drug development to Asia. http://www.terrapinn.com/2010/pharmatrials/ Biologic Manufacturing World Asia 2010 Biologic Manufacturing World Asia will bring together international and regional biopharmaceutical manufacturers, small biotechs, academic institutions, contract manufacturing service and technology providers to discuss trends, best offshoring, outsourcing and operational strategies for biologic manufacturing, methodologies and technologies to improve productivity, quality, efficiency and profitability. http://www.terrapinn.com/2010/biologicasia/ Pharma R&D Partnering World Asia 2010 Pharma R&D Partnering World Asia 2010 will bring together international and regional pharmaceutical companies, start-up & spin-off biotechs, research and academic institutions, professional investors, contract research service providers to network and evaluate partnering opportunities in Asia. http://www.terrapinn.com/2010/rnd/ Drug Discovery Technology World Asia 2010 Drug Discovery Technology World Asia 2010 is where leading scientists come to find solutions, ideas, collaborations and opportunities to connect with pharma, biotech R&D colleagues. If you are in the business of providing world-class products and solutions to life science research and drug discovery sector, you need to be here. http://www.terrapinn.com/2010/drugdiscovery/ Pharma & Biotech Supply Chain Asia 2010 - Logistics and supply chain strategy for pharmas, biotechs and CROs For delegates Pharma & Biotech Supply Chain Asia 2010 is the strategic platform where pharmaceutical, biotech and CROs supply chain and logistics practitioners can meet to discuss challenges facing in the Asia context. • Find the right fit supply chain and logistics model for Asia – Learn from the Pharmaceutical and Biotech Power Panel where leaders from various countries sit together and share their solutions • Re-evaluate your client-LSP relationship from a fresh point of view – Learn to form a win-win relationship and leverage on their strengths to realize long-term goals. • Case studies from leading manufacturers – Learn from their mistakes and successes and get valuable tips for the development of your own company’s logistics and supply chain strategy • 2 whole days of unparalleled networking – Meet senior level executives from Asia’s leading pharmaceutical and biotech manufacturers. Share ideas, learn from others and build valuable and lasting partnerships • Focused event – This is guaranteed to be the most relevant and cost-effective conference you will attend all year http://www.terrapinn.com/2010/pharmascm/

This Out-of-Specification Investigations webinar will begin with the confirmed out-of-specification laboratory result and discuss how the investigation is expanded into the whole organization. Why Should You Attend : Although the Barr Decision of the early 1990s surfaced the concern about out-of-specification results and investigations, many organizations have not determined how to effectively address the issue. Out-of-specification results bring out many reactions in the pharmaceutical firm: .emotional, political, finger pointing, denial. There inhibit a productive investigation and a timely conclusion of the investigation. There is still confusion in the pharmaceutical firm as to how to handle that is demonstrated to be out-of-specification. The webinar participants will learn the origin of the term out of specification and FDA concerns and opinions. They will be led through a process for the successful completion of OOS investigations. The webinar will begin with the confirmed out-of-specification laboratory result and discuss how the investigation is expanded into the whole organization. The involvement of QA, Production, Packaging, Materials Management and Quality Control will be discussed. Note:Discount available for 10% Please Contact us on (+1-650-620-3915).

Key validation characteristics of HPLC methods mandated according to cGMP and ICH guidelines and the stress studies must be considered for HPLC method used in pharma Labs. Why Should You Attend : Analytical methods are used to assure the quality of pharmaceutical products and HPLC methods are widely used in R&D and QC laboratories. Validation of these methods is mandated according to cGMP and ICH guidelines. This session will examine validation parameters and stress studies that must be considered for HPLC methods used in pharmaceutical laboratories. We will also go over validation protocol and appropriate acceptance criteria. Note:Discount available for 10% Please Contact us on (+1-650-620-3915).

Outsourcing in Clinical Trials NJ is the latest addition to our highly successful Clinical Outsourcing series of conferences. As the industry struggles to meet the challenges associated with a difficult economic climate, making the best use of available resources is more important than ever. Reducing costs and increasing efficiency during the clinical trial process is crucial to sustain the long term development of new treatments. The outsourcing of clinical trials as an alternative to keeping the process in-house has long been a popular cost saving measure but now, more than ever, sponsors needs to see real returns on their investment. The measures of success in outsourcing are clear – quicker, more cost efficient clinical trials that deliver results on time and on budget. Building on the enormous success of Outsourcing in Clinical Trials events in Boston and San Francisco, this event is a must attend for the Pharma and Biotech firms of New Jersey, Pennsylvania, New York, and the whole East Coast region. Register today to attend this event for FREE!! Visit http://www.arena-international.com/pharma/outsourcing/nj/register.html for more information