Pharmaceutical Outsourcing: A Russell Publishing Publication

Drug Discovery World Asia 2011 is a strategic and scientific conference for discussing innovation, technology and partnership in driving drug discovery and pre-clinical development in Asia

Pharma Partnering World Asia 2011 will bring together pharmas, start-up & spin-off biotechs, research and academic institutions, professional investors, contract research service providers to network and evaluate partnering opportunities in Asia.

BioPharma Asia Convention 2011 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!

Pharma Trials World Asia brings together global and Asian pharmas, biotechs, CROs and clinical trial solution providers to explore effective and efficient clinical trial development in Asia.

Bio IT World Asia is a strategic and scientific conference where global and Asian pharmas, biotechs, research and academic institutes and solution providers discuss the latest enabling technologies and research breakthroughs that impact drug discovery pipeline.

Biologic Manufacturing World Asia will be the only event in Asia where senior level executives from global and Asian biopharmas share their best practices in biologic manufacturing technology applications and outsourcing strategies.

With Special Focus on - Medical Polymers and Processing - Device Manufacturing - Market Trends & Export Marketing - Regulations - Technology - Research & Market Developments - Packaging & Sterilization

Biologic Manufacturing World India is the only event in India where senior level executives from global and Indian biopharmas share their best practices in biologic manufacturing technology applications and outsourcing strategies.

This course will provide the participant knowledge of current GMPs, how they are applied in the Bio/Pharmaceutical market today, and how they will be enforced in the future. Topics included are: * Impact of facility and equipment design on GMP compliance * Risk management approach to compliance * Vendors * Commissioning, Qualification and Validation – Which one to use * Problem resolution * Part 11 in production and the laboratory A comparison between 21 CFR 210/211, 600, and 820 as well as ICH guidelines will be made as they affect combination products, normal Bio/Pharmaceuticals, and Medical Devices. Current “hot” topics and examples of recent warning letters will also be discussed and evaluated.

Drug Discovery World India is designed to facilitate collaboration and technology transfer for scientists, researchers, R&D executives and clinicians from research institutions, pharmas, biotechs and CROs in India.

Pharma IQ’s inaugural Innovation in Clinical Design, Analysis and Reporting conference will help to open up this area to debate, facilitate discussion between like-minded professionals within the field, presenting industry professionals with a forum for learning new developments and the networking potential to forge lasting business relationships. Key topics will cover: -Ispy 2 and collaborative trials -Regulatory update: The FDA’s take on adaptive design clinical trials for drugs and biologics - Adaptive design in late phase designs - Adaptive Seamless Designs - Bayesian meta analysis

BioPharma India Convention 2010 is uniquely positioned as the only strategic event in India where global and Indian pharmaceutical companies, biotechs, CMOs, CROs, academic institutions and many others come together to assess the latest trends, partnerships and solutions. It will be held jointly with World Pharma Trials India 2010, Biologic Manufacturing World India 2010 and R&D Partnering World India 2010.

This continually updated course covers current FDA regulatory requirements and ICH guidelines as applied to designing stability programs from the early stages of product development all the way to approval. Among the topics to be discussed will be: identifying FDA’s regulations and ICH guidelines for stability testing, writing study protocols and SOPs, designing and validating stability indicating analytical test methods, establishing Successful Stability Data Management Systems, conducting and documenting OOS results and deviations, and preparing for an FDA inspection of stability program.

This course provides attendees with an understanding of the role 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 DMF 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. The course offers methodologies and techniques on: * 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

Good Manufacturing Practice regulations (cGMPs) are used by pharmaceutical, medical device and food manufacturers as they produce and test products that people use (Drug cGMPs also apply to the veterinary drugs). In the United States (U.S.) the Food and Drug Administration (FDA) has issued these regulations as the minimum requirements. This course explores the regulations through which the Federal government controls the drug, cosmetics and diagnostic industries. Major emphasis is placed on understanding the need for and the intent of regulations and developing mechanisms for implementation and compliance. This course is intended to give participants an introduction to cGMP regulations and their application to laboratory studies and manufacturing processes. It will also provide participants with an understanding of terminology and the role GMPs play in assuring their validity. Those attending will also get an understanding of the needs for thorough and comprehensive training and documentation. Additionally, this course introduces students to the principles of GLP/GMP in the pharmaceutical and associated industries with the emphasis on the necessary procedures and documentation required to achieve full compliance. Upon completion of this course, students will have an understanding of the various aspects of GMP regulations including: * Attributes of materials, including formulation components, container and closure systems, labels and labeling, materials in process, and finished pharmaceuticals * Methodology, including documentation, manufacturing validation, quality assurance, quality control, and supportive manufacturing operations * Personnel and facilities, including building, equipment, instruments and infrastructure * Analytical and laboratory validation and compliance programs * The process of an FDA inspection and the compliance auditing process * "The Concept of Compliance" - understanding the why behind the GMP regulations

This verification of Compendial methods webinar training will discuss the requirements of USP <1226>, what are FDA expectations related to method verification. This webinar will provide an in-depth discussion of USP <1226>, 'Verification of Compendial Methods' requirements. FDA 483s on the subject of Method Verification will be discussed to understand current FDA expectations. Conditions under which Methods can be classified as 'basic' and not require verification will be discussed. The factors under actual conditions of use which impact method performance and make method verification necessary will be addressed. FDA 483s on the subject of Method Verification will be discussed to understand current FDA expectations on which compendial methods needs to be verified.

Pharmaceutical Serialisation & Traceability 18 – 19 November 2010, CCT Venues Canary Wharf, London • Protect Against Counterfeiting • Protect Your Bottom Line • Protect Your Patients Pharma IQ’s Serialisation & Traceability Conference 2010 will taking place in London this November, will explore the following topics to help you achieve a smooth transition to mass serialisation and in turn maximum protection for patients and your bottom line. • Effective navigation of changing legislation to ensure complete compliance at an international scale • Understanding how global harmonisation of coding standards will be achieved through GS1 initiatives • Insights into best practice strategies for supply chain stakeholders to prepare effectively for changes to pharmaceutical packaging and security • Analysis of the effective implementation of various coding standards with case studies including Turkey and USA to enable optimisation of your coding approach • Evaluation of the most effective technology and tools for authentication, diversion detection, returns verification, tamper evident packaging and overt and covert security features to protect against counterfeiting • Exploration of serialisation and authentication from the perspective of pharmacists to enable the development of robust measures against counterfeiting at every step in the supply chain Contact us to learn more about this outstanding conference that will help you to implement new coding approaches in a cost effective manner, guaranteeing 100% compliance, and patient and revenue protection. Phone: +44 (0)20 7368 9300, email enquire@iqpc.co.uk or go online www.pharmaserialisation.com.

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. The current regulatory climate will be discussed in depth and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues which have caused difficulties for Life Sciences firms will also be discussed. Course content will also explain how Japan interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. The course will also discuss how personnel can best address the conflicts that sometimes arise and the approach that can best be taken for resolution. This course will also be useful for sales or general management personnel who need an overview of the Regulatory Compliance requirements within Japan and how best to consider the country into one’s Business Strategy.

This is a three-day course designed to provide individuals with an in-depth understanding of the clinical research process, the roles and responsibilities of key players, as well as, regulatory requirements. The course consists of lecture and exercises. Participants will also be placed in several real life situations such as reviewing pre-study documents and informed consent forms for completeness and compliance; conducting drug accountability; reviewing case report forms for accuracy and adherence to protocol and performing source document verification. The course is designed to provide the attendee with thorough knowledge of the following topics: * How drugs are discovered and developed for marketing approval * The four different study phases of clinical research * What constitutes Good Clinical Practices (GCP) * The principles of ICH GCP * The IRB/IEC’s composition and role/responsibilities * The IRB study review & approval process * The role and responsibilities of the investigator & study site staff * The role and responsibility of the sponsor * The history of the FDA and their role & responsibilities * Which sections of 21 CFR govern conduct of clinical studies * The purpose for an IND and its composition * How INDs are filed, reviewed, approved & amended * The IND reporting requirements * The requirements for Informed Consent * How to review an Informed Consent form for compliance * The process for Informed Consent review & approval * The administration of subjects Informed Consent * The different types of study Monitoring visits & tasks for each * Adverse Events - the types and reporting requirements * How to perform Drug Accountability & compliance * How to manage study supplies * How to detect and deal with Fraud * The purpose and composition of the NDA * How NDAs are filed, reviewed and approved * Sponsor responsibilities after approval * How to review study documents & determine compliance * How to review Case Report Forms and determine adherence to protocol * How to perform Source Document Verification

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil, Chile, Costa Rica, Dominican Republic, Mexico, Panama, Peru and Venezuela. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products. The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts that arise and the best approach for resolution.

Who Should Attend This is a basic course covering the microbial, scientific, technological, and statistical foundations of sterilization methods. The purpose of the course is to provide fundamental information on the application of sterilization methods in production processes for technicians, engineers, cleanroom designers, and supervisors. Those who may have knowledge of established processing procedures but lack a clear picture of the scientific principles of microbial destruction will benefit from this course. The course is geared for people without advanced courses in microbiology, chemical/physical science, or sterilization engineering, as well as, those looking for a review of present sterilization methods and future trends in their development and validation.. Learning Objectives Upon completion of this course, you will: * Understand the principles and practices of the basic microbiology of procaryotes and eukaryotes applied to their potential contamination of products * Understand the principles and methods for microbial detection and identification * Know the detailed scientific and technological basis of all contemporary sterilization methods o Physical and chemical methods o Filtration o Water sterilization and standards * Understand current practices for autoclave, dry heat, and radiation sterilization methods and technologies * Have a quantitative understanding of the statistical nature of sterility assurance and its validation * Understand the role of humans in the potential contamination of products * Have an overview of present regulatory mandates and guidances on sterilization of products * Have knowledge of current trends in regulatory thinking on sterilization harmonization Course Description The course provides a basic but comprehensive presentation of sterilization procedures as they are now used in the pharmaceutical industry. With an emphasis on autoclave sterilization, the course explores present-day basic scientific knowledge: from the destruction of microbials, to the manufacture of sterile products, and validation of the sterilization procedures used. Upon completion of this course, attendees will understand how and why specific sterilization methods are used in particular applications, how the methods are validated, and the strengths and weaknesses of different sterilization methods. Attendees will have exposure to quantitative analyses of microbial destruction, sterility sampling, sterility assurance, and sterilization cycle development. Participants will also be presented with the trends in microbial monitoring techniques.

Who Should Attend This course is designed for laboratory managers, supervisors, technologists, technicians, health & safety professionals, and laboratory workers with responsibilities for developing and implementing a health and safety program/system in their workplace. This training will be useful for those in the healthcare, research, pharmaceutical, and biotechnology industries. Learning Objectives Upon completion of the course, attendees will have an understanding of the critical components of a good laboratory safety program. Participants will become familiar with the skills necessary to create a “safety culture” and will be better able to deal with obstacles in implementing effective programs. Attendees will also gain insight into a wide range of resources to help with program development and implementation. Course Description This course focuses on creation and implementation of a health and safety program and addresses key topics including measuring OH&S performance and setting up a functional system. Attendees will also be introduced to the concept of the internal responsibility system and discuss how that relates to the new ANSI Z-10-2005 standard (American National Standard for Occupational Health and Safety Management Systems). Additionally, the course will address some of the “people aspects” of safety management, including: * Demonstrating the costs and benefits of safety initiatives * Encouraging compliance with the program by both new and long-term employees (dealing with perception and personalities) * Managing change towards a “safety culture” * Effective health and safety committees * Collecting and providing information and statistics that matter The course consists of oral presentation, problem solving sessions, group discussions, and case studies. Participants are encouraged to raise their own workplace issues with the expectation that they will bring back practical solutions and approaches to solve current concerns.

Forward Thinking Sourcing is looking beyond the “now” to ensure your company’s success. This program will help you transform the way your company delivers value with a PROACTIVE procurement strategy that stresses COLLABORATION and INNOVATION. Don’t miss this must-attend industry event designed for pharmaceutical and chemical sourcing and supply managers and their suppliers. Presented by DCAT’s Supply Management Committee and the Pharmaceutical Forum and Chemical Group of the Institute for Supply Management.

Speed to market is the key to driving product revenue. Managing the quality of the Phase 3 and 4 activities will impact project timing and budget and have a significant effect on the bottom line. Project managers must understand the late stage development process and the key aspects of product submission, approval and launch. Participants will learn best practices for developing and managing these trials and submissions within GCP guidelines and FDA regulations. The course will discuss the challenges associated with outsourcing, site selection, patient recruitment and data management. Clinical research that complies with international and domestic regulatory guidelines and produces high-quality data for submission is the goal. The course is interactive and designed to allow for the exchange of ideas with peers in addition to learning from the instructor.

World Stem Cells and Regenerative Medicines Congress Asia will bring together global and regional pharma, biotechs, investors and academic scientific leaders who are in the stem cell and regenerative medicines field to uncover Asia’s market potential, scientific capability and opportunities for collaborations in fast-tracking research development and commercialization of stem cell therapies and applications in the global marketplace.

Medicines and devices for children are an active and rapidly growing area of pharmaceutical research and development in response to requirements by FDA in 1997 and EMEA in 2007. Increased pressure to conduct trials in children can be daunting when faced with practical, legal and clinical considerations found only in pediatric trials. Successfully implementing regulations and ethical standards into study conduct requires a comprehensive understanding of the unique concerns raised by ethics committees, investigators and parents. This course will review a process for closing the gap between regulatory requirements and study execution. Participants will acquire strategies for risk management in the areas of regulatory compliance, protocol execution and participant safety. Guidance documents important to pediatric research will be reviewed within the context of case studies from completed programs. Participants will be given an opportunity to share their experience during working sessions on protocol design and ethical issues.

Initially, the course will discuss the regulatory expectations and other industrial references/standards that will impact your system and will include the general requirements of a vendor/supplier (outsourcing) control program followed by specific requirements for different types of supplied materials/equipment/services. During these sections, attendees will establish the documentation requirements, applicable audits and the impact of the quality agreement/contract details. In conclusion, participants will learn the maintenance aspects of such a program including handling of non-conformances, additional audits and change control. During the course, several interactive exercises will be included to provide opportunities for discussion and sharing of experiences.

BioManufacturing World 2010 is the largest global conference in China that gather international and Chinese biopharmaceutical manufacturers, CMOs, regional development agencies, technocrats, solution providers and other stakeholders to come together with a common goal to facilitate manufacturing of affordable high quality vaccines and biologic drugs in China, and ultimately improve healthcare standards of the fastest growing market in the world with 1.3 billion population. The event will feature 40+ speakers, who will share and discuss new ideas, best business strategies, most advanced technical practices and latest partnership models that will improve biomanufacturing efficiency, product quality and business profitability

Vaccine Manufacturing World 2010 is the ONLY vaccine manufacturing meeting in China and Asia Pacific region bringing together international and Chinese vaccine manufacturers, regulators CMOs, regional development agencies, platform technology and other service providers to share new ideas, discuss best manufacturing strategies, most advanced technical practices and latest partnership models that will improve efficiency, product quality and profitability, at a time of regulatory change and market boom in China. Co-located with Biomanufacturing World 2010, it the meeting place where the entire biomanufacturing industry players come together with a common goal to facilitate manufacturing of affordable high quality vaccines and biologic drugs in China, which will ultimately improve healthcare standards of the fastest growing market in the world with 1.3 billion population

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006. Gamma radiation processing is used as a product sterilization method for enormous volumes of finished medical devices and other surgical, clinical, and diagnostic products. The most common method employed to validate or qualify the process for devices has historically been Method 1, and in more recent years the alternate VDmax method has also become very popular. Both methods employ product bioburdens testing followed by analysis with sub lethal radiation exposures. This presentation will review the general requirements for validation as described in ISO 11137:2006.

This course provides a solid understanding of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will gain experience in detecting, correcting and preventing clinical study misconduct and fraud at domestic and international clinical sites. Additionally, attendees with learn how to ensure that their study conduct and supporting documentation is accurate and factual. The course will also address how to uncover misconduct, as well as, dealing with its consequences while identifying proactive solutions to prevent further problems. Included in the course work are practical examples and a roadmap for evaluating study conduct, source documents, case report forms and other study documentation through presentation and interactive case studies.

This training course provides a solid understanding of GCP requirements and clinical quality assurance overviews for clinical trials. Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites. This course teaches participants how to ensure that their data and supporting documentation are completely accurate, factual and in the appropriate format for company and regulatory authorities. Included in the course work are practical examples and a roadmap for evaluating SOPs, consent forms, investigator brochures and source documents through presentation and interactive case studies.

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. Although, the course emphasizes industrial microbiology, various types of sterilization, and facility design fundamentals, these subjects are presented in the context of regulatory compliance, Good Manufacturing Practice, and FDA/international current thinking. Please be aware that this course is designed to address aseptic filling common to biotech and pharmaceutical products. It does not address formulation development, cell culture, fermentation, preparative separations, or similar upstream or downstream processes.

This course provides comprehensive and up-to-date knowledge of development, manufacture, testing, release and/or registration of solid oral dosage forms of small molecule pharmaceuticals. The course covers formulation design considerations for tablets and capsules and unit operations utilized in the manufacture of the solid oral dosage forms. In addition, this course will cover the regulatory requirements for drug product registration (International Conference on Harmonization guidelines), including testing requirements, stability studies, and format/content of regulatory dossier for worldwide registration/approval (CTD format). This course will prepare attendees to design and execute effective formulation and process development plans for solid oral dosage forms. In addition, the course will address specific considerations in the development of challenging molecules, such as poorly water soluble drugs. The course will also cover development of specialized dosage forms such as modified release products and fast dissolve tablets.

This GCP training Webinar will discuss the principals of GCP, the regulations pertaining to it and elements necessary for FDA compliance. This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining ongoing compliance will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for their clinical studies.

This GMP webinar training on Biopharmaceutical lab provides the attendee with an overview of the GMPs as they pertain to early phase development labs. This course satisfies the annual mandatory training required for personnel employed in GMP laboratories. The GMP requirements for the sample management system, Reagents and Standards, SOPs, Personnel Training, Records and Software will be discussed. The audience will participate in a review of how implementation of Good Documentation Practices, Equipment Qualification, Method Validation, OOS Investigation and Stability programs can result in an improved lab efficiency and increase the value of data generated by the laboratory. Recent 483s issued pertaining to these areas and the consequences of not adhering to these statuary requirements will be addressed. The attendees will be trained on how to prepare for FDA Inspections, and how to respond to 483s.

Executing Global Clinical Trial Operation’s Conference Announcement, September 28-29, 2010, Embassy Suites- Washington DC Convention Center

 

Staying on top of the changing clinical trial climate in different world regions is sine qua non for sustained success, as multitude of local specific issues may influence the pace and quality of a clinical study.  Global trials help facilitate rich interaction with different cultures, medical practices and offer new avenues for innovation in different regions of the world. This conference gives a broad and relevant insight into many of these topics, carefully selected to elicit discussions and bring the best information value to professionals in the pharmaceutical and biotech arena.

 

Chaired by:

 

Mitchell Katz, PhD, Executive Director, Medical Research Operations, Purdue

 

Aleksander Skuban, MD, Director, Global Development & Commercialization, Otsuka Pharmaceutical Development & Commercialization

 

For a complete list of topics, the speaking faculty, how to register, visit www.theconferenceforum.org or call 646 350 2585. Pharmaceutical Outsourcing  readers get an additional 10% discount. Please use code POGCT.

This clinical trial audit training reviews the key elements of quality auditing processes and correlates them to the ICH guidelines and applicable FDA regulations. This Quality auditing in clinical trial training will include the key elements of quality auditing process, auditing methodology, and reporting techniques. In addition, this session will focus on reviewing recent FDA inspection findings and areas of common deficiencies. It will help you understand how key elements of quality auditing process correlates to ICH guideline and other applicable regulations.

This Radiation sterilization training will discuss how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness. This seminar will provide an overview of the requirements to validate medical devices for both Gamma and E-Beam sterilization. Validation is based on the international standard ISO 11137-1:2006 and ISO 11137-2:2006. In this one hour seminar you will obtain a basic understanding of the principles, core requirements of the ISO standard as well as related standards and guidance. We will define how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness.

In this NDA Approval Process training Webinar learn the guidance and regulations governing FDA’s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials.

With the bio-pharmaceutical industry reorganizing rapidly, changing regulatory environment, and an increasingly international market, it is critical that cold chain professionals ensure their supply chains are compliant, efficient and safe while maximizing and strengthening partnerships with logistics, data, packaging and other providers. Pharma IQ’s 8th Cold Chain Distribution for Pharmaceuticals is for pharma supply chain professionals to update practices, technologies & partners with best practices. With a promise to remain a key partner while updating operations to comply with global industry and regulatory standards, this year’s event will show how to internationally distribute medicines safely and develop strong collaborations with temperature control partners.

This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs. This presentation will discuss these roles and how the lab can assure these activities are performed in a manner that facilitates root cause excursion investigations and avoids the lab or its personnel becoming the inadvertent cause of the excursions.

This ICF process Webinar training teaches how to create an informed consent process for achieving optimal site compliance and subject comprehension. It also discusses how an inadequate ICF can affect data integrity and patient safety and/or well-being. This session will discuss the issues and consequences surrounding an inadequate informed consent process and provide tips on how to create an informed consent process that achieves optimal site compliance and subject comprehension.

Learn key factors affecting shipping and distribution of product and the stability studies that should be done to support shipping and distribution. New medicines are developed every day to meet medical needs and improve quality of life. Drug Product must maintain its identity, strength, quality and purity throughout its expiration. Physical, chemical and biological data are influenced by various environmental factors such as temperature, humidity and light. In current manufacturing environment, products can be shipped and distributed across different climatic zones. Seasonal changes as well as types of transportation can greatly affect the supply chain of the products. This session will outline stability studies to support shipping and distribution of drug products.

This 510(k) webinar training will discuss how to do a meaningful result drive 510(k)/change analysis activity so as to satisfy FDA requirements. Attend this 510(k) webinar to understand how to use the power of current risk management tools to do analysis, how to make the process risk based, how to document it, how to resolve a wrong decision.

In this GCP webinar understand The Regulatory requirements to follow to be GCP compliant for a site involved in research involving human subjects. Both the FDA and the DHHS regulations are designed to ensure that the rights and welfare of human subjects (normal healthy volunteers, patients and especially the vulnerable) is protected. At the same time the integrity and validity of the data generated gives the regulators confidence of both the safety and efficacy of the drug of device being tested. The 9 “Commitments” on the FDA Form 1572 serve as a guide to how “GCP” is viewed by the Regulatory Authorities.

This training on Forced Degradation study on a Protein Therapeutic will discuss on the Forced Degradation Studies required for Well Characterized Protein Therapeutic products and how to leverage forced degradation results to design stability studies for Drug substances. This course is designed to provide the attendee with an overview of a Forced Degradation study on a Protein Therapeutic, to interpret and leverage the results to design the Stability Studies required for registration of the BLA. The stress conditions typically used to study the tendency of the protein to undergo degradation by pathways such as oxidation, deamidation and fragmentation will be addressed. Analytical methods such as RP-HPLC, IEX, AUC and FFF required to quantitiate and characterize the degradants will be described. Leveraging the Forced Degradation results to design Stability studies for the Drug Substance and Drug Product will be discussed.

World Pharma Trials Asia is the only Asia-focused event in China in 2010, where the World’s Top Pharmas, biotechs, CROs, and regulators convene to provide the most comprehensive knowledge into the best operational strategies and practices in fast-tracking clinical drug development in Asia.

In this Pediatric Trials training learn how to evaluate the current issues and best practices in pediatric drug development, clinical investigation of medicinal products and non clinical evaluation of pediatric drug products. Attend this Webinar to understand the ethical, economic, regulatory and technical considerations when conducting clinical studies on children. Discussions evaluate the current issues in pediatric drug development and discuss approaches and best practices for overcoming these challenges.

This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC. The regulations under this mandate can vary from member country to member country concerning translation of key documents to other regulatory laws specific to that region. These additions supplement the set of harmonized standards put in place by the European Commission. These harmonized standards serve to free the flow of goods from one market to another within the EU Medical Device industry. Today, all medical devices sold in the EU must have the CE marking affixed to demonstrate compliance to this directive. If your device falls within the scope of the Medical Devices Directive, then you must meet the essential requirements of that law.

The Charles River Biotech Symposium unites drug development professionals in an interactive setting to discuss the nonclinical development of biologics, including regulatory issues and innovative program solutions. The symposium will feature many provocative presentations on the development of biopharmaceuticals, with an emphasis on challenges in the nonclinical assessment of safety and drug disposition. The popular case studies and great debate sessions will be presented on Monday afternoon. On Sunday, a workshop on the Endemic Diseases and Micro-Flora of Nonhuman Primates will be held. The spirit of the meeting and the casual Mediterranean-style Rancho Bernardo Inn setting fosters extensive information sharing, networking and educational opportunities. Please save the date and join us in Southern California for another exciting meeting.

2nd Successful eCTD Lifecycle Management Pharma IQ is delighted to announce the 2nd Successful eCTD Lifecycle Management conference, being held in Prague on the 14th and 15th of September 2010. With eCTD submissions taken a firm hold in the US and Japan, they are now making their mark in Europe. Now eCTD submissions are becoming the preferred format for regulatory submissions in Europe so it is essential that you are equipped with in-house expertise and external solutions to ensure first time compliance and submission success! This is a challenging area for all and is not something that can be easily avoided. This is your chance to hear from thought leaders and uncover the latest regulations and thinking surrounding eCTD, both now and in the not to distant future. Hot Topics You Will Discuss Include: • Harmonising document management globally, representation from the US and Europe • Migrating to New Submission Processes: Migrating to the PIM System, EFPIA Standards and Practical Pfizer Case Studies • Getting the dossier right first time: Uncovering best practice in the development of local and centralized dossiers • Managing different submission forms such as MRP and DCP • Establishing best practice when implementing eCTD across the wider business: How to approach both the roll-out and internal training that is required for smooth adoption The event already has the following confirmed speakers: • Karin Grondahl, Head of Unit, Registration and Information Management, Sweden Medical Agency • Dr Andrew Marr, Director, e-Regulatory Development, Global Regulatory Operations, PIM Steering Committee Co-Chair, EFPIA • Dr Klaus Menges, Division Strategy and Planning - Unit Scientific Quality Assurance and Process Organisation, Federal Institute for Drugs and Medical Devices, Bfarm • Lynsey Flitton, Senior Regulatory Labelling Manager, Pfizer • Jean Paul Smith, Senior Manager, Regulatory Affairs, Celgene • Dr Claudia Zerobin Kleist, MHA, Case Manager, Swiss Agency for Therapeutic Products (Swissmedic) • Laura Barrett, Regulatory Publishing, GSK • Martina Pustějovská, eDMS Project Manager, Zentiva For more information and to download the agenda please visit the website www.ectdevent.com/prague, you can also call us on +44 (0)207 368 9300 or email enquire@iqpc.co.uk.

This EO sterilization training Webinar will discuss how to modify EO sterilization process for complicated medical products which are sensitive to moisture, temperature, vacuum changes. This presentation will address the various modifications that can be made to the EO process to accomplish this goal and the impact of those modifications. We will discuss the methods to limit moisture exposure, Running a low temperature process, How to address vacuum sensitivity, How to reduce EO residuals.

This drug development process training Webinar will give an overview of drug development process, the regulatory requirements and the analytical technology used for pharmaceutical analysis supporting R & D. New medicines are developed every day to meet medical needs and improve quality of life. Pharmaceutical companies spend a lucrative average of between 800 million to 1.2 billion dollars in R&D to bring a new drug to market. The analytical development program plays a critical role in the pharmaceutical industry, where much effort is spent on developing testing procedures to ensure quality, safety and efficacy of new drug product. Modern as well as conventional technologies are used to screen medicines, release materials, test final products, select packaging or establish expiry. This seminar will give a brief overview on the drug development process, global regulatory requirements for registration of new medicines and the types of analytical technology that are used for pharmaceutical analyses to support research and development.

In this Effective Standard Operating Procedure (SOP) training learn how to develop a comprehensive, consistent SOP. The critical elements of a SOP which is easier to understand follow and review by operating personnel. Current Good Manufacturing Practices (cGMPs) continue to be the standard practices in the pharmaceutical industry. Each company must develop their own set of Standard Operating Procedures (SOPs) based on cGMPs; however, most of warning letters and regulatory observations are due to non-adherence to SOPs. This discussion will bring up several key factors to develop a comprehensive, consistent SOP. It will define critical elements of a structure SOP to make it easier to understand, follow and review by operating personnel. It will also discuss the consequences of SOP misuse and benefits of an effective training program.

This change control webinar will discuss the change control activities and documentation required to meet GMP requirements. This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated change control activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance and past problems. It will help attendees understand and recognize the most common change control failings and their fixes, and assist in defining and recognizing changes.

This water systems webinar training will discuss the myths surrounding microbial monitoring and control approaches and alert you to the pitfalls of believing these myths which could cause over-confidence in a system’s design for microbial control or the suitability of your microbial test methods. It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? There are many reasons, which will be discussed, but regardless of the causes, we need to be aware of these myths and understand how it really should be done. A number of water system myths will be discussed that are related to microbial control approaches as well as microbial monitoring. Each myth will be explained as to its origin and then put into true context with how the supposed microbial control or monitoring approach SHOULD be handled. You will probably be surprised to learn which of your own "rules of thumb" are actually quite wrong!

The International Society for the Study of Xenobiotics (ISSX) is the premier scientific organization for researchers interested in the metabolism and disposition of xenobiotics. The study of xenobiotics (medicinal drugs, agricultural chemicals, industrial chemicals, environmental contaminants and other exogenous substances) encompasses the introduction into, distribution and transport throughout, interactions with and elimination of these compounds from biological systems. The studies on xenobiotics include the rates and extents of the processes and the biological consequences.

PharmaNet Development Group is pleased to announce that it is hosting a Phase IV symposia entitled "Safety and Value: Critical Success Factors for Post-Approval Research". Date: Thursday, 2nd September, 2010 Location: Royal College of Surgeons, 35-43 Lincoln's Inn Field, London, WC2A 3PE Key note speakers from companies such as PharmaNet, Eisai Europe and Abacus International will all be presenting during the event. Featured topics include: . Strategic Post-Approval Research Planning . The Evolving Post-Approval Regulatory Environment in Europe . Issues in Safety, Epidemiology and Risk Management . Obtaining Real-World Evidence through Observational Research and Patient Registries . Establishing Product Value through Health Economies and Outcomes Research (HEOR) . Post-Approval Case Studies For more information or to register, please contact Patricia Hall at PHall@pharmanet.com or call + 609-951-08540.