Past Events

Renowned for its popular and influential international conferences on "Organic Process Research and Development", Scientific Update is proud to announce the return of this exciting event tailored for the Asian process chemistry community. This conference will feature a mix of international and local presenters who will provide a forum for the discussion of issues related to synthetic route design, development, optimisation and scale-up. The conference will contain a variety of industrial presentations, selected to emphasise their companies' approach to these issues, with case studies in the development of new processes.

The World Cancer Immunotherapy Conference is bringing together leading scientists and C-Level executives from across the globe to present research, case studies and viewpoints on various topics integral to a better understanding of the challenges and opportunities facing developers of therapeutic cancer vaccines. Speakers and panelists at this conference will discuss the following: Cancer vaccine clinical trial design, FDA guidance for cancer vaccine developers and regulatory challenges, biomarkers as an aid to clinical development of cancer vaccines, optimal disease settings for cancer vaccine intervention, cancer vaccines in combination therapies

Arrowhead Publishers and Conferences’ World Cancer Immunotherapy Conference will take place January 25-26, 2012 in San Diego, California. The conference has been organized to bring together leading scientists and C-Level executives from across the globe to present research, case studies and viewpoints on various topics integral to a better understanding of the challenges and opportunities facing developers of cancer immunotherapies.

Pharmaceutical Packaging is a very specialised area with its own unique issues and problems. This one day course will provide delegates with a good basic grounding and appreciation of what is required for the packaging of pharmaceutical and healthcare products. Whether you know nothing, have a basic understanding or are familiar with the area, this course will provide you with the useful knowledge and insights from experts who have each worked in the industry for over 25 years. What it covers? • Packaging component and material selection • Key properties of various packaging materials/systems • Pack testing and evaluation • Packaging component specifications • Printing processes and controls • Artwork generation and control • Regulatory requirements eg MA packaging requirements, Braille, 2D Data Matrix barcodes, Child resistance, Tamper Evidence, Readability and others • Transit packaging • Trade/Supply Chain requirements

The purpose of this course is to give an overview of photostability,and where it fits in the stability testing programme and the importance of photostability. The course is highly interactive and held in a relaxed environment. It will cover: • Why do we do photostability tests? • Concepts and background in photostability • Identifying drug substances most likely to absorb light and display signs of poor photostability • Understanding photostability terminology • Where does phototstability fit in the overall stability testing program? • Why does photostability matter? (exercise)

New and important techniques in stability testing are facilitating product development using the Quality by Design approach. Using these it is possible to develop products more quickly and reliably, through improved methods of shelf life prediction and excipient testing. New stability testing protocols using the published ASAP method from Pfizer can generate information quickly and reliably. The purpose of this course is to give a comprehensive, integrated overview of pharmaceutical stability testing in a highly interactive, relaxed environment:  Why is stability testing required for product registration and GMP purposes?  What are the requirements for Clinical Trials, new, and existing products?  How can stability testing be applied during product development to shorten development times as well as improve product quality  Stability testing outsourcing - successful management and execution It will include:  A comprehensive review of ICH stability testing guidance ICH Q1A  Pitfalls in stability testing. Outsourcing—costs and benefits  New approaches to stability testing including ASAP and the role of peroxides in product stability  Stability Testing and QbD  Workshops for attendees to present and discuss their own stability testing issues with the group

Quality by Design principles are being applied throughout the pharmaceutical development process and stability testing is no exception. Stability testing of biological products presents specific challenges in respect of product type and characterisation, especially the complexity of both active substances and the products. This course covers all of the relevant regulatory, ICH and GMP guidance including stability study design and principles of QbD on Day 1. On Day 2, we look at the specifics of evaluating biological products, generation of stability data, specification setting and shelf life evaluation. The course will include: • Stability Testing and QbD • Why is stability testing required for product registration and GMP purposes? • What are the stability test requirements for Clinical Trials, new, and existing products? • How can stability testing be applied during product development to shorten development times as well as improve product quality • Stability testing outsourcing - successful management and execution And • Biological product evaluation and analytical methods • Product characterisation • Setting specifications and shelf lives • Ongoing stability testing of biological products for product maintenance and GMP

Integrating SAMPLE PREPARATION 2011 is an internationally recognized event for experts in sample preparation for detection, identification and analysis of chemical & biological agents, threats and pathogens. This conference will address the major issues and current state-of-the-art in the technologies related to the important phases of real-world sample preparation such as: - Increasing recognition of sample preparation as the biggest challenge for biodefense and biomedical detection applications - Sample preparation as a separate system vs. an integrated module approach - End-user perspective for biodetection and sampling technologies and devices - Is remote detection without sample preparation a viable option? - Major challenges of sample preparation system integration approach - Recent advances in standalone sample preparation systems technology development - Point-of-care/clinical applications for pathogen/virus/threat sampling, detection, and analysis - Food, water, air, and environmental sampling - Alternative and disruptive approaches to sample preparation technologies Novel robust sampling and bioforensic techniques will be reviewed as applicable to biodefense, field & point-of-care biomedical & clinical applications, food & water testing, and environmental & agricultural sampling.

Effervescent products present particular problems in manufacture, which result from their special requirements and particular utility. In this one day workshop led by two leading experts, the issues surrounding the development and manufacture of effervescent products are explored in depth including practical sessions. Background • What are the advantages and disadvantages of effervescent tablets? • What are their particular requirements? • Why do they present problems? The course is designed for people working in formulation, process development or manufacturing with responsibility for the development, validation and manufacture of effervescent products. The content will complement that of the Tablet Formulation and Tablet Process Development courses which immediately precede it. Course Programme Try it!! The workshop... Using a laboratory tablet machine and some simple equipment, we experiment with effervescence and develop some simple products. Theory • Effervescence systems. What are they and how to they achieve their objectives • Uniformity – achieving and assessing uniformity in effervescent systems. • Taste and taste masking • ODTs • Specific problems with effervescent products—mixing, lubrication, compression. Practice. Effervescent products in Production. • Engineering requirements for effervescent products • Process Validation—challenges and pitfalls • Scale up and Technology Transfer—mixing issues • Routine manufacture

This interactive workshop provides up-to-date, relevant and detailed information on the impact of Quality by Design (QbD) on the Development and Validation of tablet manufacturing processes. It will also study the identification and evaluation of Critical Product Attributes and Critical Process Parameters for tablets, and their implications for process control. We develop new concepts including the use of risk and process matrices for risk management. The latest ICH and FDA guidance on Quality by Design and Process Development, published in 2009, will be comprehensively reviewed. By the end of the course, you will . Understand the relationship between the principles of QbD and tablet development and process validation in generic and new product development . Understand the relationship between material properties, formulation development and process development . Understand the processes commonly used to manufacture tablets and the factors which affect them . Recognise how to identify critical processing parameters, and how to incorporate into a process validation program . Understand the principles of PAT, how and where it can be most effectively deployed . Know the latest FDA thinking on Process Development including the three key steps of validation

Oral Solid dosage forms as Tablets and Capsules, are some of the most convenient and most used methods of drug delivery. This 1-day interactive workshop is intended to provide an understanding of the fundamentals of Oral Solid Dosage manufacture and to highlight the dependency between the various process steps. Some of the benefits to be derived from this workshop include: • An understanding of the basics of the Tablet Making Process. • An appreciation of the demands of the new production environment • An appreciation of the individual’s role in improving quality at all process stages • A knowledge of “how things work” and how this may help in trouble shooting & fixing problems

This unique 2 day course introduces and integrates the key elements of tablet development based on the principles of Quality by Design (QbD) set out in ICH Q9. It will include experimental, hands-on experience of formulation development and will cover: • The product development lifecycle • Preformulation studies • Formulation development Proper integration of all of these elements is essential to achieve “Quality by Design” because data from each phase is used to control the next step in the development process. By achieving proper integration based on sound scientific principles, many development and production problems can be avoided. The course includes case studies of tablet development at the preformulation and formulation development phases as well a detailed step by step analysis of all elements of the tablet manufacturing process. Hands on, practical studies will underpin the scientific learning in this participative course.

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications. This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development. Upon completion of this course, delegates will have learned what is necessary to develop and validate methods for drug substance and drug product to comply with international regulatory guidelines. The course is designed for Scientists working with HPLC who need to further their understanding of the technique in order to develop better methods faster. Scientists who have to validate methods HPLC methods in accordance with current internationally-accepted guidance. HPLC technicians working in R&D laboratories, quality control laboratories and stability testing laboratories. Managers with a responsibility for generating regulatory submissions.

This unique 2 day course introduces and integrates the key elements of tablet development with the principles of Quality by Design (QbD). It will include experimental, hands-on experience of formulation development using the Gamlen Tablet Press. Topics include: Day 1 The Product Development Lifecycle • Making sense of ICH Q8, 9 and 10 - moving from theory to practice • Designing formulations and processes to meet the Target Product Profile Formulation development • Formula selection • Process selection • Product Optimisation and the formulation cycle • Developing Product Control Strategies at the formulation development phase • Coating polymers Day 2 Advanced characterisation and development techniques • Formulation mapping using X-ray and Raman spectroscopy • AFM in formulation development • Real time particle size analysis • Dryer control using NIR • Blend uniformity assessment using NIR and other techniques • Compressibility comparison using the Gamlen Tablet Press • Characterisation of tablet coats using THz spectroscopy

This unique 2 day course identifies the studies needed to characterise the physico-chemical properties of drug substances in the context of tablet development. Proper understanding of drug substance properties is essential for both candidate selection (during the Research process) and pharmaceutical development. On Day 1 of the course we introduce the key elements of tablet development and the principles of Quality by Design (QbD), and the potential impact of drug substance properties on tablet development. On Day 2, we study some of the numerous recently developed techniques for rapid and scientific assessment of drug substances using techniques such as Atomic Force Microscopy (AFM), high stress stability testing (ASAP - Waterman), and Raman Spectroscopy. We include experimental, hands-on experience of material compaction using the new Gamlen Tablet Press.

Pharma-Bio-Med & BioSciences is the premier Information Conference & Exposition in Europe tailored specifically to the interests of Information, Library, Knowledge Management and Informatics Professionals working with bioscience data and information in industries such as pharma and biotech, food, nutrition, agriculture/crop science, cosmetics, diagnostics and devices, academic and government health sciences fields. Professionals working with bioscience information in research, development, regulatory or commercial stages in the life cycle of a product should consider attending the Pharma-Bio-Med & BioSciences conference. No other conference in Europe so precisely fulfils the need for the professional development and continuing education of professionals working in these areas.

This one day seminar is aimed at QA staff in drug products manufacturers and especially their QPs who have specific responsibilities under directive 2004/27/EC. Participants will learn about the legislators’ perspectives and the key differences between APIs and products, which lead to different audit techniques and thought processes when auditing API manufacturers. The seminar includes: the background to current GMPs for APIs , FDA and EU interpretation of GMPs for APIs , specific opportunities from the guidelines that API manufacturers may exploit , specifics of what to look for when auditing an API site.

Widely publicized safety incidents and recalls of lithium-ion batteries have raised legitimate concerns regarding lithium-ion battery safety. Battery Safety 2011 is conveniently timed with Lithium Battery Power 2011 and will address these concerns by exploring the following topics: - Application specific battery safety issues affecting battery performance - Major battery degradation and reliability factors - Battery management systems - Commercial cells evaluation and failure analysis - Advances in testing techniques and protocols - High throughput testing, automation and modeling for better safety - Regulatory issues

This 2-day interactive workshop is intended to provide an overview of the challenges that must be overcome in transferring technology and to highlight some proven techniques for overcoming those challenges. Some of the benefits to be derived from this workshop include: • An appreciation of where TT fits in the life cycle of a pharmaceutical product • An appreciation of the importance of planning and product transfer • An overview of the potential complexity of technology and product transfer • An outline of proven best practice in technology transfer • An opportunity to discuss current issues and challenges in technology transfer with peers and with an expert faculty

Significant lithium-ion battery innovations have propelled this technology to a position in the marketplace far exceeding original market survey expectations. Breakthroughs in new battery chemistries, novel electrode and electrolyte materials, system integration for a vast array of mobile and portable applications, from micro medical devices to high-energy/high-power automotive, have set the stage for an emerging market with unlimited potential. The 7th Lithium Battery Power conference will guide attendees from technology and materials development through device packaging and integration to applications in a mobile power marketplace and is conveniently timed with the 2nd Battery Safety conference. Program topics include: - New chemistries & materials to increase energy & decrease cost - Meeting the EV challenge: cycle life, power & energy, cost and safety - Advanced materials for improved electrode & electrolyte performance - Application driven lithium ion battery development - Advanced technology for greater safety, reliability and performance - From novel materials and components to systems design and integration - Role of nanotechnology in improving power and energy density