PURCHASE MATERIALS

Unable to attend in person? If you are not able to make it to a PharmaEd Resources event but would like to stay abreast of industry developments, conference proceedings are available for purchase. For more information, contact info@pharmaedresources.com or Click Here to order online.

2008 PRE-FILLED SYRINGES FORUM Strategic Development, Inspection, Safety & Regulatory Compliance and Commercialization of Pre-Filled Syringes June 5 - 6, 2008- Sheraton La Jolla Hotel, La Jolla, CA Featuring Case Studies and Lessons Learned! · Development and Commercialization of a Pre-Filled Product · Evaluating Proper General Trends for Autoinjectors and Pre-Filled Syringes · Manufacturing and Outsourcing Strategies of Pre-Filled Syringes · Examining Potential Interaction Between Pre-Filled Syringes and Biopharmaceutical   Products · Inspecting Pre-Filled Syringes for Both Particulate Matter and for Cosmetic Defects · Syringe Plunger Movement During Air Shipments · Suitability for Intended Use Considerations for Pre-filled Syringe Systems                                                                                                   ......And much more View Brochure I Purchase Materials

CONTAINMENT OF POTENT COMPOUNDS Implementing Risked-Based Approaches and Ensure Safety through Strategic Containment Operations and Processes May 29 - 30, 2008, Radisson-Warwick Hotel, Philadelphia, PA Lessons Learned from Leading Industry Experts: · Understand the Requirements for the Containment of Potent Compounds · Lessons Learned from the Field: Program Development and Implementation Steps · Retrofitting Existing Equipment and Facilities to Achieve Requirements · Defining Design Requirements and Achieving Innovative Design Approaches · Numerous Industry Case Studies on Design, Implementation and Risk Management Featuring In-Depth Coverage on: FLEXIBLE CONTAINMENT SYSTEMS Installation, Validation and Achieving Compliance Company Representation Includes: Genzyme Floura, LLC Ash Stevens, Inc. Powder Systems Ltd. Astrazeneca Torres Placa Industrial Corporation Containment Solutions Roche Colorado Corporation Hecht Germany ILC Dover’s Containment Products SafeBridge Consultants Inc. Stantec Consulting Services, Inc. IES Engineers View Brochure I Purchase Materials

QbD: QUALITY BY DESIGN Understanding and Implementing the FDA's Quality by Design Initiative for the Pharmaceutical Industry May 29 - 30, 2008 - Radisson-Warwick Hotel, Philadelphia, PA Case Studies and Lessons Learned from Leading Experts: · Facilitate Innovation and Continuous Improvement Throughout the Product Lifecycle · Provide Regulatory Flexibility for Specification Setting and Post-approval Changes · Streamline the Submission and Review Processes · Use a Risk-Based Approach to Designing Performance Characteristics for the Operation Used for the Manufacture of Drug Products · Understand the Regulatory Requirements for QbD Featuring an In-Depth Pre-Conference Workshop: IMPLEMENTING A QUALITY BY DESIGN (QBD) APPROACH View Brochure I Purchase Materials

$295 Per Conference  Proceeding EXTRACTABLES & LEACHABLES 2008 Strategies to Ensure Safety and Compliance in the Packaging and Processing of Drugs and Biologics March 10 - 11, 2008- Radisson Warwick Hotel, Philadelphia, PA Featuring Case Studies and Lessons Learned from Industry Experts! · Examine Best Practices for Extractables and Leachables and Assess and Manage Risk · Determine Suitability for Use in Extractables/Leachables Assessments · Manage Extractables and Leachables Resulting from Packaging Materials, Closures and   Excipients · Determining Extractables and Leachables from Disposable Single Use Manufacturing   Systems In-Depth Pre-Conference Workshop: Eric B. Sheinin, Ph.D., Sheinin & Associates; Former USP Chief Science Officer and Ex-FDA Deputy Director, Office of Pharmaceutical Sciences Featuring Representation From: Wyeth Pharmaceuticals Northup Regulatory Toxicology Services Baxter Healthcare Corporation Helvoet Pharma Merck & Company West Monarch Analytical Laboratories Pall Life Sciences Jazz Pharmaceuticals Metron Technologies View Brochure I Purchase Materials

$295 Per Conference  Proceeding MANAGING DRUG SAFETY: Strategic Adverse Event Management and Pharmacovigilance Strategies to Minimize Risk March 10-11, 2008 - Radisson Warwick Hotel, Philadelphia, PA Featuring Case Studies and Lessons Learned! · Detail the Differences Between the US and EU Requirements and Prepare for Worldwide   Safety Inspections · Understand the 3 FDA Guidances Concerning Risk Management Programs · Determine the Opportunities and Challenges of Patient Registries for Efficient Risk   Management · Management and Reporting of Adverse Events: Best Practices and Tools · How Adaptive Trial Design Can be Used to Maximize Drug Safety Information · Advanced Quantitative Post-Marketing Safety Signal Analysis In-Depth Pre-Conference Workshop: Strategic Risk Management Plan Development: Utilizing Current Tools to Ensure Safety and Expedite Approvals Led by: David I. Goldsmith, MD, FISPE, President, Goldsmith Pharmacovogilance and Systems Yola Moride, PhD, FISPE, President, International Society for Pharmacoepidemiology (ISPE) Featuring Representation from: Merck & Company Intrasphere ParagonRx Phase Forward - Lincoln Technologies SJ Pharma Consulting Sciformix Corporation United BioSource Corporation Sanofi Pasteur MSD Wyeth Apotex Almac Clinical Technologies View Brochure I Purchase Materials

$295 Per Conference  Proceeding 2007 LYOPHILIZATION CONFERENCE Optimizing the Lyophilization Cycle through Strategic Application, Processes and Technologies June 25-26, 2007 Radisson Warwick Hotel, Philadelphia, PA Featuring Case Studies and Lessons Learned from Industry Experts from Multiple Scale-Up and Cycle Development Projects! · Explore Current Methods in Cycle Development and Control · Developing a Lyophilization Process that is Beyond Trial and Error · Excipient Selection and Thermal Analysis of Formulation and Finished   Product · Chamber Considerations for Primary and Secondary Drying · Comprehensive Coverage! · Understanding Container and Closure Needs for Lyophilized Drug   Products View Brochure I Purchase Materials

$295 Per Conference  Proceeding IMPURITIES FORUM 2007: Strategic Identification and Detection, Control and Methods to Ensure Regulatory Compliance for APIs and Drug Products September 10-11, 2007 Radisson Warwick Hotel, Philadelphia, PA · Examine FDA, ICH, and USP Approaches to the Control of Impurities   Choose and Evaluate Tools for Impurities Identification · Genotoxic Impurities: Understanding the Additional Challenges Posed · Using Chromatography and Mass Spectrometry to Identify Impurities   Strategies for Residual Solvents Testing and Methods Validation EXTRACTABLES AND LEACHABLES COVERAGE! Toxicology Considerations and Risk Assessment Strategies Strategies for Identifying Leachables and Impact of Photoinitiators Determining Leachables Using HPLC Multi-Detection Systems View Brochure I Purchase Materials

$295 Per Conference  Proceeding ADAPTIVE TRIAL DESIGNS Maximizing the Use of Interim Data Analysis to Increase Drug Development Efficiency and Safety September 10-11, 2007 Radisson-Plaza Warwick, Philadelphia, PA · Featuring Case Studies and Lessons Learned From the Field:   Design, Planning and Implementation of over 300 Adaptive Trials · Know when to use an adaptive vs. traditional design and address possible pitfalls for   each type of design · Understand what is necessary to obtain FDA buy-in to proposed study designs · Know the associated costs and tackle difficulties that will be encountered with adaptive   design implementation · Plus! Practical Considerations for Adaptive Trial Management and Logistics   · Assuring quality of field monitoring and availability of clinical trial supplies   · Refining operations strategy: enrollment, CRA time, site efficiency and performance View Brochure I Purchase Materials

$295 Per Conference  Proceeding DISSOLUTION TESTING CONFERENCE Strategies for Selection, Data Interpretation and Analysis and BA/BE June 25-26, 2007 Radisson-Plaza Warwick, Philadelphia, PA · Learn Best Practices for Dissolution Testing from Leading Industry   Experts · Strategies for Selection of Dissolution Media for Poorly-Soluble Drugs · Detecting and Addressing Changes and Understanding Regulatory   Implications · Hear Industry Case Studies and Important Lessons Learned View Brochure I Purchase Materials