2019 Pre-Filled Syringes Forum, Boston
2019 Pre-Filled Syringes & Auto Injectors Forum
February 27-28, 2019, Metro Meeting Centers, Boston, MA
With the Pre-Filled Syringes market expected to top $16 billion dollars by 2021, the industry is looking for next generation materials, technologies and production strategies to streamline commercialization and to adapt quickly to a changing regulatory environment. Pharma Ed Resources, an industry leader since 2004 in delivering market-driven research on PFS, is proud to announce its 2019 Pre-Filled Syringes Forum. Pharma Ed brings together top scientists, regulatory experts and innovators to share best practices and the latest research in this field, enabling you to maximize your organization's leverage in this dynamic and growing market.
Featuring Representation From:
- Biogen
- Genentech
- Allergan
- Bristol-Myers Squibb
- GSK
- Sanofi Genzyme
- Janssen R&D
- Merck
- Shire
- Ompi
- MedImmune
- Ypsomed AG
- PTI
- Datwyler
- Toxikon
- Bosch
- West
- Unchained Labs
- GessNet
- Zeon
Featuring Comprehensive Coverage On:
- Next Generation Materials & Design of Pre-Filled Syringes
- Understanding Regulatory Requirements for PFS and Auto Injectors
- Latest Auto-Injector Designs, including Wearable-Injector Devices, Pen Injectors, Bolus Injectors, and Patch Pumps
- QbD Applications in the Manufacture of Pre-Filled Syringes
- Leachables and Safety Considerations in Pre-Filled Syringes
- Extractables and Leachables - Toxicological Perspectives on ICH M, and other Guidelines for Efficient Product Development
- Improving Drug Stability in Pre-Filled Syringes
- Pre-Filled Syringes vs. Single Dose Cartridges
- Optimizing Aseptic Filling Processes, Including Automated Inspection
- Challenges in the Use of PFS for Biologics
Silver Sponsor:
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Data Integrity & Pharmaceutical Quality Compliance Summit
March 4-5, 2019, Metro Meeting Center, Boston, MA
Featuring In-Depth Coverage On:
- Regulatory Guidance for Data Integrity
- A Regulatory Global View on Data Integrity and its Importance
- Examining FDA Integrity Guideline
- Creating Data Integrity Programs
- Data Integrity During Process Validation and Commerical Product Transfers
- CMOs and Data Integrity
- How to Detect the Lack of Data Integrity
- Data Integrity for Complex Analytical Systems. How to Deal Effectively with Vendor-Provided COTS Solutions?
- Data Integrity in cGMP realized in global Pharma corporate projects
- Performing a Risk Assessment for Data Deficiencies
- Data Lifecycle Management
- Process Validation and Technology Transfer of Biologics and Vaccines
- Software Validation Case Study: Validation of MES System
With Representation From:
Event Sponsors:
Extractables, Leachables & Elemental Impurities 2019
Ensuring Quality, Safety, Suitability and Regulatory Compliance for Drugs, Biologics and Medical Devices
April 10-11, 2019, Metro Meeting Center, Boston, MA
This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical and biotech industries, including drug packaging and delivery components, single-use systems, medical devices, and parenteral drug products. In addition, we will focus closely on the keys to satisfying recent ICH and USP guidelines for metal impurities in current and future drug products and biologics; recent revisions to USP chapters; and the recently revised standards contained in ISO 10993.
Featuring In-Depth Coverage On:
- Implementing ICH Q3D, and USP Guidelines Regarding Elemental Impurities: Case Studies and Regulatory Expectations
- Update on ongoing revisions to USP and for Materials and Components used in Pharmaceutical Manufacturing Systems
- Update on ongoing revisions to ISO 10993 Revised Standards for Medical Devices
- Meeting Regulatory Expectations for E&Ls in Drug Products, Delivery Systems, and Medical Devices
- The Proper Use of Extractables Data
- Toxicology Assessment Approaches for E&L Studies
- E&L Best Practices for Inhaled Products and Inhalation Devices
- E&L Best Practices for Medical Devices & Combination
- Designing and Improving Risk-Based Assessment of E&L Data for Drugs, Biologics, and Medical Devices
- GC-MS Applications for Detection of Leachables
- Exploring Biocompatibility Vs. Chemical Assessment in E&L Study Design
- E&L Evaluation for Complex Pharmaceutical Formulations
- Issues Frequently Observed in Analytical Evaluation of Leachables in Drug Products
- E&L Considerations in the Qualification and Validation of Single-Use Systems
- E&L Best Practices for Oral Dosage Forms
- Understanding Leaching Associated with Lyophilized Drug
- Products Stored in Vial/Stopper Packaging Systems
- Addressing E&Ls from Bioprocessing Equipment & Product Packaging
With Representation From:
- FDA (pending approval)
- PPD
- Sartorius Stedim
- VR Analytical
- Fresenius Medical Care
- Intertek
- Med Institute
- Triad Scientific Solutions
- Nitto Avecia
- Knoell Germany GmbH
- Material Needs Consulting
- Smithers
- Exova
- Eakins & Associates
- Risk Science Consortium
Event Sponsors:
Media Sponsors:
Register before January 10 to receive $300 off the standard rate!
Inhalation Drug Delivery Systems 2019
May 28-29, 2019, Boston, MA
Featuring In-Depth Coverage On:
- Regulatory Compliance Issues for Inhalation Therapies
- Combination Product Design
- Achieving An Inhaled Insulin Product
- Developing A Generic Inhaled Product
- Sterilization Issues Surrounding Inhalation Therapies
- Extractables and Leachables Testing
- Nebulizers, E-Cigarettes and Vaporizers: Past, present and future
- Alternative Therapeutic Fields: Inhaled Antibiotics
- Future directions in inhalation and respiratory drug delivery research
- Novel Technologies For Pulmonary And Nasal Delivery
- The Challenge Of Developing Inhalation Devices
- Applying QbD Principles to Inhalation Therapies
- Improving Patient Adherence With Product Design
- And more!
With Representation From:
- Genentech
- Merck
- GSK
- Aptar
- Smithers
- Harro Hofliger
- Nelson Labs
- Exova
- Intertek
- Toxikon
- EKG Labs
- Material Needs Consulting
- Vas Analytical
- University of Florida
- University of Texas
Event Sponsors:
Media Partner:
2019 Process Validation Summit
June 12-13, 2019, Sheraton La Jolla, CA
Are you compliant with FDA requirements for process validation? Today's regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes throughout a drug product's lifecycle. This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.
With Representation From:
- AstraZeneca
- Bristol-Myers Squibb
- Bausch + Lomb
- Celgene
- Alphora
- Jubilant Pharma
- VTI Life Sciences
- Charles River Laboratories
- Pharmatech Associates
- SynoloStats
- VolPal
- Shook, Hardy & Bacon
- Compliance Team, Inc.
- Caliber Therapeutics
- Beckman Coulter
- Alcon
- STERIS
With Comprehensive Coverage On:
- Introduction to Recent Advances in Process Validation - Life Cycle Approach
- Regulations/ICH Guidance/FDA, EU perspective/PV, life cycle approaches
- Validation in the Biopharmaceutical Industry
- Continued Process Verification (stage 3) approaches, understanding & realization
- Quality-by-Design, PAT, Quality Risk Management - new product vs. legacy
- Statistical Process Control & Sampling Plans
- Global Tech Transfers and Process Validation Approaches
- Process Validation Biologics vs. Biosimilars, Biobetters
- Business Perspectives on PV
- Process Validation Biologics vs. Biosimilars, Biobetters, OTC Manufacturing
- Enhanced Sampling in Process Performance Qualification and Continued Process Verification
- Systematic Method for Process Development and Successful Implementation Based on Lessons Learned
- Process Validation as the Bridge from Clinical to Commercial
- Statistical Methods for Small-Scale Model Qualification in Bioprocessing
- Benefits of Establishing a True End-to-End, Close to Real-time Robustness Monitoring Program
- And Much More!
Early Bird Special: Register by February 1st!!
Transdermal Drug Delivery Systems- September 11th and 12th
Boston, MA
Cleaning Validation- September 26th and 27th
Boston, MA
Cannabis and the Pharma Industry- October 24th and 25th
San Diego, California
Tentative Pre-Filled Syringes repeat in San Diego in mid-November
La Jolla, CA