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
• Delivery of Inhaled Drug Products Using PRINT Technology
• 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
• Element
• Intertek
• Toxikon
• EKG Labs
• Material Needs Consulting
• Vas Analytical
• University of Florida
• University of Texas
• Noveome

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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!

2019 Pre-Filled Syringes Forum, San Diego, CA

September 4-5, 2019, Sheraton La Jolla, La Jolla, CA

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 In-Depth Coverage On:

• Integrated Strategy and Approach to Combination Product Development for Biologics
• Challenges and Opportunities for Development of Stability Program for Combination Products
• Tools for Calculating the Return on Investment in Human Factors Engineering for Injection Systems
• Post-marketing Safety Reporting for Combination Products
• Analytical Challenges and State-of-the-Art Solutions Related to Chemical Safety Assessment of Pre-Filled Syringes
• Combi Filling - Challenges and Solutions
• Platform-Based Drug Delivery Combination Product Risk Management: Challenges and Best Practices
• Precision Capability of Peristaltic Pump for Filling High-Concentration Monoclonal Antibody Solutions at Low Fill Volumes
• Biologics Formulation for COP Syringe Optimized to Eliminating Use of Surfactant
• Container Closure Integrity Assessment of PFS and Cartridges in Manufacturing and Transportation – Options, Approaches and Future Trends in Ensuring Product Safety
• Particles in Intravitreal Injections
• Flexible Primary Container Closure Systems: Reimagining the Future of Parenteral Drug Delivery
• Pre-Filled Syringes Novel Approach & Technology: Increasing Safety and Performances in the Delivery of Demanding Biodrugs
• Framework For Evaluation of Pre-Filled Syringe Systems
• The Role of Human Factors in Evaluating Innovative Injectables
• Tackle Pre-Filled Syringe QC With Bouncer
• What Is "New" In the Area of Autoinjectors, Pen Injectors, Patch Pumps and Wearables?
• The Evolution in Vacuum Decay Leak Testing Technology

With Representation From:

• Takeda
• Biogen
• Johnson & Johnson
• Eli-Lilly & Co.
• Medimmune
• Genentech
• Bosch
• Intertek
• Ompi of America
• Ypsomed
• Zeon
• Toxikon
• Gessnet
• West
• Merck
• Suttons Creek

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Standard Registration: $1895
Early Bird Special: Register by: May 15th and save $200 (off of standard pricing) Call for government or academic pricing

Microneedle, Transdermal & Intradermal Drug Delivery Systems, 2019

September 18-19, 2019, Metro Meeting Centers, Boston, MA

For the past six years, Pharma Ed's annual Transdermal & Intradermal Drug Delivery conference has attracted hundreds of attendees from the US and abroad. We bring together top experts from academia and industry to share their research in this emerging field of drug and biologics delivery.

Featuring In-Depth Coverage On:

• Next Generation MN Systems: Delivering High Drug Doses Transdermally Using Microarray Patches
• In Vitro Permeation Testing in Dermal Drug Discovery and Development
• Overcoming Unique Challenges Facing Skin Delivery Systems
• Delivering Therapeutic Peptides—A Case Study Using a Solid Microstructured TD System
• Latest Advances in Microneedle Drug and Vaccine Delivery
• Optimizing Dissolving Microneedles & Coated Microneedles for Drug Delivery
• Improving Formulation Design in Dermal/Transdermal Drug Delivery
• Mechanisms of Dermal and Transdermal Absorption of Drugs
• Regulatory and Experimental Considerations for Extractable and Leachable Analysis of TDD Systems
• Exploring the Therapeutic Potential of Cannabinoid Medicines Via Skin Delivery
• And more!

With Representation From:

• 3M
• University of Maryland
• Merck
• Queens College
• UC Dublin
• Diteba
• JUVIC
• Vaxxess
• Zosano Pharma
• Mercer University
• Texas Tech
• Gattefosse
• Incyte Corporation
• University of Miss.
• Intertek
• Material Needs Consulting

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Early-Bird Pricing: Register by July 1st for only $1,795!

Data Integrity & Pharmaceutical Quality Compliance Summit

October 3rd and 4th, 2019, Sheraton La Jolla, CA

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:

Early Bird Special: Register by July 1st and Receive a $300 Discount off of Standard Pricing!!

Cleaning Validation 2019

October 9-10, San Diego, CA

Featuring In-Depth Coverage On:

• Cleaning Standards Covering Both Drugs and Devices
• Prepare for FDA inspections
• Establish and Maintain Cleaning Validation Processes in Compliance with cGMPs
• Automation for Rapid Cleaning Process Development
• Application of Risk Assessments to Cleaning Processes
• Risk-based Selection of Analytical methods
• Address specific cleaning validation activities of complex equipment
• Optimize manual cleaning validation processes and operator qualification for manual cleaning
• Understand sampling and analytical methods for cleaning applications
• Implement process controls for the removal of bacteria, fungi and viruses
• Risk-based Implementation of Total Organic Carbon Analysis (TOC)
• Application and Qualification of Visual Inspection
• Identification of Unknown Residues Found in Cleaning Validations
• Statistical Evaluation of Cleaning Validation Data
• Application of Bayesian Statistics to Cleaning
• ASTM Standard on Science and Risk-Based Cleaning Process Development and Validation
• ASTM Standard on Science and Risk-Based Cleaning Process Development and Validation
• Case Study for Low-Risk Manufacturing
• ASTM Standard on Derivation of Health Based Exposure Limits (ADEs/PDEs)
• How to use ADEs/PDEs for Setting Cleaning Acceptance Limits
• Analytical Approach for Implementation of Visual Inspection
• And more!

With Representation From:

Event Sponsors:

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Early Bird Special: Register by July 1st and Receive a $300 Discount off of Standard Pricing!!

Extractables & Leachables Forum 2019- West Coast

November 18-19, 2019 Sheraton La Jolla, CA

Ensuring Quality, Safety, Suitability and Regulatory Compliance for Drugs, Biologics and Medical Devices

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 revisions to several applicable USP chapters and the recently revised standards contained in ISO 10993.

Featuring In-Depth Coverage On:

• The Ongoing Development of USP Chapters and Dealing with Materials and Components Used in Pharmaceutical Manufacturing Systems
• Issues Frequently Observed in Analytical Evaluation of Leachables in Drug Products (An FDA Review Experience)
• Toxicological Risk assessment of Medical Device Constituents-The New Working Draft of ISO 10993-17
• Understanding the Major Revisions to ISO 10993 and the New European Medical Device Regulations
• ISO 10993-18: Chemical Characterization of Medical Devices
• Application of ISO 109993-12 Exhaustive Extraction to Support Biocompatibility of Implantable Devices
• Exploring Biocompatibility Vs. Chemical Assessment in E&L Study Design
• Revisiting the PQRI/USP Identification Categories for Leachables and Extractables
• The Use of Simulation Extractions to Address Leachables for Single Use SystemsExtractable and Leachable Evaluation for Complex Pharmaceutical Formulations
• The Proper Use of Extractables Data - Aspects Beyond Extractables Measurement
• Advanced Identification Methods for E/L from Packaging & Manufacturing Components
• Understanding Leaching Associated with Lyophilized Drug Products Stored in Vial/Stopper Packaging Systems

With Representation From:

• FDA
• PPD
• Sartorius Stedim
• VR Analytical
• Fresenius Medical Care
• Intertek
• Med Institute
• Triad Scientific Solutions
• Nitto Avecia
• Knoell Germany GmbH
• Material Needs Consulting
• Smithers
• Element
• Eakins & Associates
• Risk Science Consortium
• SGS

Event Sponsors:

Register by July 1st for Early Bird Discount!

Canna-Pharma 2019

Advancing the Science of Medical Cannabis Through GMP, Quality Control, Analytical Testing & Regulatory Compliance

November 13-14, 2019 Sheraton La Jolla, CA

The retail cannabis market in North America will soon exceed $25 billion. Though the federal government still classifies cannabis as illegal, 33 states have approved its use for medicinal purposes, and 10 states have made recreational use legal as well. In 2018 Canada became the first nation in the western hemisphere to legalize marijuana for both recreational and medicinal use, making it the largest national market for legal cannabis worldwide. Nevertheless, the state of scientific knowledge on medicinal cannabis remains immature, and the regulatory environment in North America fragmented and contested. That is why you cannot afford to miss Pharma Ed's Canna-Pharma 2019. This two-day event will explicitly link current knowledge and practice in the pharmaceutical and cannabis industries, providing a forum for scientific dialogue aimed at both advancing and applying best practices in this growing field. Research scientists, analytical experts, drug developers, drug device manufactures, cleaning validation experts, cannabis cultivators and labs, and public policy makers will come together to advance the science of cannabis.

Featuring Expert Speakers From

• ASTM Committee D37
• NRC-Canada
• AOAC Cannabis Working Group
• AHPA
• USP Medical Cannabis Expert Committee
• International Cannabis & Cannabinoid Institute
• Agilent Technologies
• Gattefossè
• Steep Hill Labs
• Americans for Safe Access
• Diteba
• Steris
• Alconox
• Medicinal Genomics
• University of Maryland
• VividGro
• LexKannabis LLC
• GBS Global Biopharma
• Vas Analytical
• Colorado Department of Public Health & Environment
• Maryland Medical Cannabis Commission

And Comprehensive Coverage On:

• Challenges in Creating Standards for Quality Control of Cannabis Derived Products
• Updates from Industry Working Groups: ASTM D37, AHPA, USP, & AOAC International
• Analytical Testing Strategies for Pesticides, Trace Metals & Other Contaminants
• Regulatory Panel Discussion—Hear from the Experts
• Cannabis Genetics: The Path to Better Medicinal Cannabis
• Hot Topics in Therapeutic Cannabis Research
• Key Formulation Considerations for Improved Bioavailability of Cannabinoids
• Evaluating the Volatile Constituents of Different Cannabis Varieties using Various Sample Preparation Approaches, and Mass Spec Detection
• New Approaches to Pesticide Analysis in Cannabis
• Environmental Monitoring for GMP Compliance in Grow Facilities
• Cannabis Microbiome Sequencing: Implications for Cannabis Safety Testing
• Cleaning Validation and GMPs for Medicinal Cannabis Products
• The Therapeutic Potential of Cannabinoid Medicines Applied on the Skin
• Intellectual Property Considerations for Medical Cannabis
• And Much More!

Event Sponsors:

Register by July 1st for Early Bird Discount!