About Us  ·  Sign up for E-mail  

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      

 
Privacy Policy   ·   Home   ·   Contact Us
Phone: 217.355.7322   ·   Fax: 847.589.0708   ·   Mail: info@pharmaedresources.com