Pharmaceutical Outsourcing: A Russell Publishing Publication

Advances in science and technology are leading to research and development of a wide array of new vaccines and novel manufacturing approaches that are being applied in new areas of disease prevention. Technical and regulatory challenges currently being faced by the vaccine industry as these products are brought to the market will be examined and discussed at the PDA/FDA Vaccines Conference. Experts from the vaccine industry, government and non-government agencies will provide a forum for discussion of many important vaccine development, manufacturing, and regulatory issues.

New laws, regulations and guidance continue to evolve helping to stimulate innovation toward enhancing good manufacturing, distribution and importation practices. Building on earlier PDA-cosponsored conferences and workshops on pharmaceutical supply chains, the PDA/FDA Pharmaceutical Supply Chain Conference will provide a forum for further implementation of innovative approaches aiming to prevent illicit acts such as counterfeiting, diversion and economic adulteration from threatening the safety of the drug supply.

PDA's 7th Annual Global Conference on Pharmaceutical Microbiology will bring together all levels of industry professionals to network and benefit from a program that reveals the essential science of microbiology and seeks to solve the problems that our industry faces on a daily basis. The comprehensive program agenda will include presentations from regulatory and industry representatives from around the world who will share recent case studies, current and future trends in the field of pharmaceutical microbiology.

The Universe of Pre–filled Syringes & Injection Devices conference will present case studies from industry experts, new developments, regulatory considerations, challenges and industry trends on all aspects of the application of parenteral products.

The 2012 Pharmaceutical Cold Chain & Good Distribution Practice Conference will provide guidance on the handling and distribution of temperature-sensitive pharmaceuticals as it relates to patient safety and product integrity.

The PDA Biennial Training Conference has been designed to provide participants with innovative knowledge, skills and proven tools to increase employee performance within a regulated environment. The conference is designed for anyone with training responsibilities in the bio/pharmaceutical industry and will provide the most current information needed to strengthen your training expertise. The format will include keynote speakers, workshops and round table discussions where you will have the opportunity to share ideas and interact with other training professionals.

The 2012 PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today’s leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes.

The 2012 PDA Innovation & Best Practices on Sterile Technology Conference will bring together all levels of industry professionals to network and benefit from a program that will explore new and improve best practices on sterile technology. This 2 day conference will provide participants with a comprehensive review of contemporary practices for the conduct of terminal sterilization and aseptic processing with special emphasis on process simulation, risk assessment/mitigation, parametric release and post-aseptic fill lethal treatments.

In the recent past there have been several recalls and increasing concerns about pharmaceutical glass packaging. Pharmaceutical manufacturers, regulators, and glass suppliers all share a common goal of assuring the highest quality products (including packaging) for patients. The PDA/FDA Glass Quality Conference will discuss these issues; best practice to preventing and/or detecting at risk glass packaging; and review current expectations to ensure that recalls are avoided and container closure integrity is assured.

The PDA/FDA Virus and TSE Safety Conference will bring together all levels of industry and regulatory professionals to network and benefit from a program that demystifies the underlying science of Virus and Transmissible Spongiform Encephalopathy (TSE) Safety. The comprehensive program agenda will include presentations and panel discussions from representatives from around the world who will share recent case studies, current and future trends, and hot topics in the industry.

The PDA Chemistry Manufacturing & Controls (CMC) Workshop will gather attendees to facilitate discussion of concepts captured in the A-Vax case study (public availability scheduled for early 2012) within the vaccine industry and with regulatory health authorities. The focus of presentations will be the exploration of tools and frameworks to enable ICH Q8, Q9, and Q11 implementation strategies in vaccine development.

The GCSG meeting is one of the finest forums to share exchange and learn new information about clinical supplies, while benchmarking how the rest of the industry is doing with their clinical supply chain challenges. Each year the reviews from meeting attendees are glowing and the membership and attendance continues to grow. This is the perfect opportunity to gain industry knowledge through presentations and workshops, network with colleagues and interact with Supply Chains top Vendors.

The GCSG meeting is one of the finest forums to share exchange and learn new information about clinical supplies, while benchmarking how the rest of the industry is doing with their clinical supply chain challenges. Each year the reviews from meeting attendees are glowing and the membership and attendance continues to grow. This is the perfect opportunity to gain industry knowledge through presentations and workshops, network with colleagues and interact with Supply Chains top Vendors. More information is available at www.MYGCSG.COM

The PDA Annual Meeting is the one meeting each year dedicated to advancing the careers of pharmaceutical and biopharmaceutical professionals by focusing program content on science and technology innovation as well as optimized performance. As the manufacturing of quality products is a keystone of our industry, the 2012 PDA Annual Meeting's theme is Manufacturing Innovation: Achieving Excellence in Sterile and Emerging Biopharmaceutical Technology. This meeting is an opportunity to participate in presentations, case studies and initiate discussions on manufacturing innovation, productivity in large scale sterile manufacturing and contract manufacturing, automation, and new technologies such as personalized medicine and cellular therapeutics.

Biologics World Korea provides the ONLY biologics and biosimilars focused platform in Korea that brings together Korean and international biopharma leaders, innovative biotechs, and technocrats to convene and discuss on strategies, latest technologies and best practices. Biologics World Korea 2012 brings you: The most targeted platform to meet Korean and international biologics manufacturers Case studies and discussions from senior level decision makers who will influence the direction of Korea's biologics industry For more info, visit http://www.imapac.com/index.php?page=BiologicsWorldKorea2012 Both strategic and technology-focused biologics development in Korea

The PDA Taskforce for Single-Use Systems is completing a Technical Report on the implementation of Single-Use Systems and would like to invite you to attend the PDA Single Use Systems Workshop being held April 18-19, 2012 in Phoenix, Arizona. The workshop will showcase and encourages the philosophies championed in the Technical Report and offer a different approach, presenting science and risk-based concepts which are flexible and can be applied in many different situations and organizations.

Why Should You Attend: This course provides attendees with an understanding of the role that Quality Agreements and DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of when Quality Agreements are appropriate, how they should be prepared, formatting, content and negotiations around the agreement. The DMF section will explain preparation and explain the types of information essential for any Drug Master File. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.Areas Covered in the Seminar: The Course offers methodologies and techniques on: Quality Agreements * The Origin and Background around Quality Agreements. * When are Quality agreements appropriate? * The Scope of Quality Agreements. * Quality Agreement Formatting and Content. * How to negotiate a Quality agreement. DMFs * Who really needs a DMF and why? * The various types of DMFs - which is best for your products. * The relationship between DMFs and drug and biologics applications. * The symbiotic relationship between DMFs and current Good Manufacturing Practices (cGMPs). * Common DMF errors - how to avoid them. * How to deal with deficiency letters and their origins? * Effective change control strategies. * Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspectional trends.

This course provides a thorough understanding of the activities involved during Phase 3 and 4 of drug development. The objective is to provide detailed knowledge of project management practices, and tools that will make the difference between a successful clinical trial and one that does not meet its goals. The course will focus on issues that impact late stage R&D, including product launch and commercialization.

Efficient and effective management of Phase 1 and 2 clinical trials can significantly impact the time, scope and budget for the development of a drug or device. Project managers must understand the development process and the key aspects of Phase 1 and 2 in order to act, react, and adapt to change when the program moves forward and new data is acquired. Successful completion of Phase 1 and Phase 2 clinical trials are key project milestones. This course focuses on the best practices for developing and managing these trials within GCP guidelines and FDA regulations. The course will discuss the challenges associated with clinical trials run outside the United States and identify key differences, common pitfalls, and cultural challenges. Guidance for the “how-to” will be provided, along with problem solving for specific situations such as slow enrollment, high screen failures, or issues with data quality. The course is interactive and designed to allow for the exchange of ideas between peers in addition to learning from the instructor.

This two-day course is meant for those who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot, or commercial setting. Whether for biopharmaceutical or pharmaceutical applications, this course presents the technical basics that govern aseptic processing, and provides practical advice for attendees to troubleshoot and manage their aseptic operations.

The 9th Two Day Conference On Indian Medical Devices & Plastics Disposables Industry 2012 March 23 - 24, 2012 Venue: Ahmedabad Management Association, Ahmedabad, Gujarat, India WITH SPECIAL FOCUS ON - Medical Polymers and Processing - Device Manufacturing - Market Trends & Export Marketing - Regulations - Technology - Research & Market Developments - Packaging & Sterilization WHO SHOULD ATTEND - Medical Device Manufacturers - Drug Packagers - Research Organisations - Quality Certification Agencies - Regulatory Agencies - Designers - Manufacturers Of Tubes And Injection Moulded Components - Manufacturers Of Clean Room & Sterilisation Supplies - Medical Plastics Processors - Plastics and Additive Producers - Machinery Suppliers - Universities And Testing Laboratories - Financial Institutions

This two-day seminar is designed for personnel in the pharmaceutical, biotechnology, medical device and biologics industries who use Contract Research Organizations (CROs) in the process of developing their products for FDA approvals. Participants will learn how to write a Request for Proposal (RFP) and use that to find, evaluate and select the right CRO for the work they need to outsource. Methodology for comparing and contrasting vendor responses to the RFP will be discussed. Attendees will also learn techniques for successfully managing CROs and the shared responsibilities required by the sponsor and the service provider. Additionally, participants will learn how the current external and internal forces are shaping the way projects will need to be delivered to be competitive and cost efficient given the state of the industry.

Vaccine World Summit India 2012 will be THE DEFINITIVE meeting place for vaccine industry's leaders from India and the rest of the world. Riding on the momentum generated by the successful 2011 event, which attracted over 130 delegates and 42 renowned speakers, Vaccine World Summit India 2012 promises to be an even greater experience! Set the stage for the next wave of innovation and discovery in vaccines today! Join us in March 2012! Highlights of the 2012 event: Manufacturing technology updates aimed at boosting vaccine production while maintaining high quality standards Sharing of new vaccine technologies to improve efficacy and safety Discussions on efficient navigation of regulatory landscapes to market Indian vaccines internationally

This course is designed for personnel involved in preparing the chemistry, manufacturing and controls (CMC) section of a NDA or IND in CTD format. Participants will gain a thorough understanding of the requirements for each CMC section of the Common Technical Document (CTD), i.e., the format to be used for NDAs. Additionally, the course will suggest ways to streamline the preparation of CMC documents, present techniques for making the CMC submission easy to review, and discuss how to address issues during CMC meetings with the FDA.

DCAT Week is one of the largest gatherings for the pharmaceutical and related industries in the world. Its unique model brings industry CEO’s, presidents, global sales managers and directors of supply chain management from around the globe for high-level meetings, strategy sessions, education programs and networking events, including the DCAT Annual Dinner.

R&D Innovation: From Concept to Action! The 5th Annual GDDIF is the leading R&D Summit for decision makers, scientific leaders and strategists. It is the only two day gathering dedicated to scientific insights, technology Innovation & strategy across the entire R&D realm. GDDIF is the forum for senior level discovery and development executives to come together and engage in interactive workshops, intimate panel discussions and network with industry peers to procure and re-examine their challenges & objectives now and in the crucial years to come. GbxSummits has elected 40 of the most influential leaders and forward thinkers in the drug discovery & development realm. The delegation is produced on behalf of GbxSummits and invitations are based on the level of responsibility and experience for both the delegate and speaker.

Hilton San Diego Bayfront • San Diego, CA 9 Conferences – 1 Location - www.IBCLifeSciences.com/BDPWeek

This course will benefit all product development and clinical team members who touch some aspect of clinical documentation, and help them understand the importance of a robust clinical document management system that meets specific trial needs. By the end of this two-day session, attendees will understand the varied documentation requirements of global clinical trials and be able to assess documentation needs in the context of electronic, paper or hybrid systems. Additionally, participants will develop a firm understanding of the roles and responsibilities of sites, sponsors, CROs and other stakeholders in relation to clinical documentation. Development of Standard Operating Procedures (SOPs), the Trial Master File and conducting compliant audits will also be given significant attention.

Now, in its 5th year the Pharma Resource Planning and Portfolio Management event will build upon our previous years by continuing the focus on overarching portfolio management instead of individual project management, but will look more in-depth at resource building to keep operations in-house, strategies for a more productive portfolio review process and more consideration of the market conditions looking ahead using forecasting techniques. Delegates will also hear from a wide variety of relevant perspectives beyond branded pharma including med device, biotech, generics and consumer healthcare experts. Delegates will leave the conference with strategies to improve their resource allocation programs and in turn better manage their portfolios. Take-home lessons include ways to prioritize your current projects and new R&D projects to increase the possibility of a high return on your investments, which is especially critical in an unstable economy and an environment where pipelines are drying up and the cost to research and develop new products is rising. Please visit: http://www.marcusevansch.com/ELCHC441 for more details.

The Only Event for Canadian Cold Chain & Temperature Controlled Life Sciences We are excited to bring you the 10th anniversary special CC & Temp Management Summit for February 27-29 2012 in downtown Toronto. Temperature control and sensitive handling are fundamental requirements of most life sciences products today. The 10th annual February 2012 event will address how Canadian and International quality distribution professionals are implementing new data monitoring processes, passive technology and supply chain integrity plans. For more information – call 1-800-882-8684, email Courtney.green@iqpc.com or visit www.coldchainpharm.com

Risk Mitigating and Productivity Improvement through Successful Partnering & Co-Development with CMOs February 27-28, 2012 - Hilton San Diego Bayfront • San Diego, CA Part of IBC’s Biopharmaceutical Development & Production Week This conference provides you insights into developing your risk-mitigation strategies and operational excellence that oversees supply chain security and raw material reliability, thereby delivering a successful agent-sponsor relationship and ensuring consistent high quality products from your CMO partners. Complete event details and online registration can be found at: www.IBCLifeSciences.com/Outsourcing Mention priority code BDP12PON to save 20% off the standard rates. New registrations only.

Maximizing Facility Throughput, Accelerating Timelines and Ensuring Partnership Success in Technology Transfer February 27-28, 2012 - Hilton San Diego Bayfront • San Diego, CA Part of IBC’s Biopharmaceutical Development & Production Week This conference gives you an inside look at trouble-shooting transfer challenges while developing strategies to minimize risk, enhance productivity, and ensure efficient and smooth technology transfers. Complete event details and online registration can be found at: www.IBCLifeSciences.com/Transfer Mention priority code BDP12PON to save 20% off the standard rates. New registrations only.

Combining Technical and Scientific Innovations with Industry Collaboration to Overcome Bioprocessing Challenges February 27-28, 2012 - Hilton San Diego Bayfront • San Diego, CA This conference offers you the highest quality and most in-depth coverage of the latest technical and scientific advances in bioprocessing to help companies (of all sizes) improve the speed, quality and cost of developing and producing antibodies. Exclusive case studies delivering the latest data together with strategic discussion forums allow the industry's leading scientists, engineers and executives to collectively collaborate and provide solutions to their most pressing challenges. Complete event details and online registration can be found at: www.IBCLifeSciences.com/Antibodyprod Mention priority code BDP12PON to save 20% off the standard rates. New registrations only.

Strategies to Identify, Test, Control and Mitigate Risk of Raw Material Variability in Upstream/Downstream Development and Clinical/Commercial Manufacturing February 27-28, 2012 - Hilton San Diego Bayfront • San Diego, CA New to the market, this conference offers strategies to identify raw material variability as a potential problem before it happens, solutions for controlling and mitigating the risk of raw material variability in process development and manufacturing and techniques for working with raw material suppliers to ensure raw materials meet quality/safety standards. Complete event details and online registration can be found at: www.IBCLifeSciences.com/RawMaterials Mention priority code BDP12PON to save 20% off the standard rates. New registrations only.

Approaches to Overcome the Unique Technical and Scientific Challenges of Developing Novel Molecules February 27-28, 2012 - Hilton San Diego Bayfront • San Diego, CA This conference covers the entire spectrum of topics related to improving the efficiency of developing and producing next generation and novel molecules. The conference presentations bring together the industry experts representing companies of all sizes to share successful approaches that can help you overcome the unique technical and scientific challenges in upstream and downstream processing. Complete event details and online registration can be found at: www.IBCLifeSciences.com/Recombinant Mention priority code BDP12PON to save 20% off the standard rates. New registrations only.

Implementing Novel Analytical Approaches and Technologies from Early to Late Stage Development to Enable Project Progression February 27-28, 2012 - Hilton San Diego Bayfront • San Diego, CA This conference offers you the unique opportunity to hear how your peers are successfully developing and integrating novel analytical approaches and technologies to optimize quality at every stage of process and product development. Attendees will learn how companies are developing and implementing the analytics of the future and their impact on bioprocessing. Complete event details and online registration can be found at: www.IBCLifeSciences.com/Analytical Mention priority code BDP12PON to save 20% off the standard rates. New registrations only.

Moving Towards a LifeCycle and Risk-based Approach for Continuous Validation February 27-28, 2012 - Hilton San Diego Bayfront • San Diego, CA Part of IBC’s Biopharmaceutical Development & Production Week This conference provides insights into the interpretation and implementation of FDA's Process Validation Guidance and QbD approaches, while examining the roles and impact of knowledge management and quality risk management on continuous verification. Complete event details and online registration can be found at: www.IBCLifeSciences.com/Process Mention priority code BDP12PON to save 20% off the standard rates. New registrations only.

Strategies, Technologies and Regulatory Perspectives for Detection, Prevention and Remediation in Upstream, Downstream and Manufacturing Operations February 27-28, 2012 - Hilton San Diego Bayfront • San Diego, CA With up-to-date strategies for detection and prevention efforts for laboratories and facilities, various new methods for virus spike preparation and the implementation of platform processes/ modular viral clearance, as well as updates from several regulators representing the FDA and the European regulatory bodies, this event will attract forward thinking people from across the industry. Complete event details and online registration can be found at: www.IBCLifeSciences.com/ViralSafety Mention priority code BDP12PON to save 20% off the standard rates. New registrations only.

Why Should You Attend: This 6 hour virtual seminar will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in Japan, the importance of partner selection and add the cultural knowledge needed for success. The recent changes made by PMDA to be more sponsor-friendly will be reviewed. Real world experiences on actual intAgenda: (All time in EST) * 10:00 am EST to 12:00 noon (Session I) * 12:00 noon to 1:00 pm (Lunch) * 1:00 pm to 3:00 pm (Session II) * 3:00 to 3:15 pm (Break) * 3:15 to 3:45 pm (Conclusions and Final Comments) * 3:45 - 4:00 pm (Q&A Session) eractions with the Agency since these changes, will also be discussed.

Create a competitive advantage and revolutionise your manufacturing strategies and technology at the Annual Bioinnovation Leaders Summit.It is the leading manufacturing meeting for decision makers, and strategists and it is the only two-day gathering dedicated to tackling the industries key pain points combined with next generation technology Innovation & strategy across the entire manufacturing and supply chain realm. The summit is designed with an interactive and engaging format, where influential leaders from around the world and across all the relevant areas, meet to debate and explore with their peers the key technology developments and opportunities at present and in the years ahead. It brings together approximately 120 industry leaders and principle scientists to engage in interactive workshops, panel discussions, and networking sessions to add value in both their key objectives and challenges. GbxSummits has elected 40 of the most influential leaders and forward thinkers in the drug discovery & development realm The delegation is produced on behalf of GbxSummits and invitations are based on the level of responsibility and experience for both the delegate and speaker.

The Annual PIMS Leaders Summit is the leading manufacturing meeting for decision makers, and strategists. It is the only two-day gathering dedicated to tackling the industries key pain points combined with next generation technology Innovation & strategy across the entire manufacturing and supply chain realm. PIMS is designed with an interactive and engaging format, where influential leaders from around the world and across all the relevant areas, meet to debate and explore with their peers the key technology developments and opportunities at present and in the years ahead. The summit brings together approximately 120 industry leaders and principle scientists to engage in interactive workshops, panel discussions, and networking sessions to add value in both their key objectives and challenges. GbxSummits has elected 40 of the most influential leaders and forward thinkers in the drug discovery & development realm The delegation is produced on behalf of GbxSummits and invitations are based on the level of responsibility and experience for both the delegate and speaker.

Description The US FDA has issued a draft guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended soley in Phase 1 studies.With this guidance and an accompanying regulation, US FDA formally recognizes specific standards for the manufacture of small amounts of drug products for phase 1 studies and formulating an approach to cGMP compliance that is appropriate for the particular stage of drug development. This presentation will give an insiders insight into the the new guidance and regulation and discuss the rationale for such.Areas Covered in the seminar: * Background and rationale for guidance and proposed regulation * Scope * CGMP Statutory and Regulatory Requirements * Recommendations for complying with the statue- personnel,Quality Control Function, facility and Equipment, Control of Components, Production and Documentation, Laboratory Controls,Container Closure and Labeling, Distribution and Record keeping * Special production situations * Biological and Biotechnological Products * Sterile products/aseptically processed products * Questions