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. Please Note: With the exception of Extractables/Leachables 2010, all materials from 2012 or earlier are no longer available for purchase.

Process Validation Summit 2017

May 18-19, 2017, Philadelphia, PA

Are you compliant with FDA requirements for process validation? This two-day intensive summit brings together industry leaders to help you exceed regulatory thresholds and avoid costly FDA inspection findings.

With Representation From:

  • FDA
  • Abbott
  • Bayer
  • Genzyme
  • GSK
  • QPharma
  • Patheon
  • Pfizer
  • Arlenda
  • Snee Associates
  • PharmaTech Associates
  • Compliance Team Inc
  • ResMedica
  • Stat4Ward
  • Takeda
  • BergumSTATS
  • TARIS Biomedical
  • Tunnell Consult

Featuring Comprehensive Coverage On:

  • FDA Process Validation and Risk Management Approaches
  • Lifecycle Approach to Process Validation
  • Global Technology Transfer and Process Validation
  • Achieving the Business and Compliance Benefits of Quality by Design (QbD) and Continued Process Verification (CPV)
  • Legacy Products - From Retrospective to Prospective Process Validation
  • Validation Sampling Plans and Statistical Process Control
  • Cost-effective Process Validation Lifecycle Management
  • Implementing a Comprehensive Strategy for Process Validation: Stage 3, Continued Process Verification
  • Establishing a Continuum of Criticality for Process Parameters and Quality Attributes Throughout the Lifecycle
  • Process Control Strategy and Process Performance Qualification of a Drug/Device Combination Product
  • The Drug Supply Chain Security Act-How Does it Relate to Validation?
  • And Much More!

2017 Pre-Filled Syringes Forum

Strategic Development, Safety & Regulatory Compliance, and Commercialization of Pre-Filled Syringes

April 10-11, 2017, Racquet Club of Philadelphia, PA

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 2017 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.

With Representation From:

  • Biogen
  • Pfizer
  • Allergan
  • Eli Lilly & Co.
  • Regeneron
  • Sanofi Genzyme
  • MedImmune
  • Terumo
  • Aptar Stelmi
  • BD
  • West
  • Ypsomed
  • rapID
  • Aspen Research
  • Exova
  • Zeon
  • Arlanxeo
  • Bosch
  • CS Fullerton
  • Eakins & Associates

Featuring Comprehensive Coverage On:

  • Key Factors in Combination Product Development: Regulatory Hurdles in Receiving PFS and Pen Approvals for Human Factors Studies
  • Patient Centric Designs For Pre-Filled Syringes
  • Next Generation Materials & Design of Pre-Filled Syringes
  • Improving Quality, Connectivity, and Cost Control in Combination Products & Autoinjectors
  • Smart Devices: Their Emerging Role in Auto-Injector Systems
  • Sterile Manufacturing of Injectables at CMO's
  • Extractables case study of resins HDPE, TPU & PEBAX
  • Managing the Materials used to Construct Pre-Filled Syringes - Selection and Supply Chain ControlLatest Market Trends and Needs for PFS
  • Overcoming Complex Requirements for Biologic Drug Delivery
  • And Much More!

Extractables, Leachables, & Elemental Impurities 2017

Ensuring Quality, Safety, and Regulatory Compliance for Drugs & Biologics

March 6-7, 2017, Racquet Club of Philadelphia

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of USP and ICH guidelines, as well as the upcoming revisions to three major ISO 10993 standards. This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, and parenteral drug products. We will hear from key industry working groups such as PQRI and BPOG. 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.

With Representation From:

  • Boehringer Ingelheim
  • Allergan
  • Pfizer
  • Genentech
  • Amgen
  • NSF Health Sciences
  • Janssen
  • Eurofins
  • Merck
  • Aspen Research
  • Lilly
  • Boston Analytical
  • Regeneron
  • West Pharmaceutical Services
  • Sanofi
  • Material Needs Consulting
  • Baxter
  • Eakins & Associates

Featuring Comprehensive Coverage On:

  • Updates & Case Studies on the Latest Compliance Implications of USP and and ICH Q3D Risk Assessment Filing Guidelines for Elemental Impurities
  • The Risk Assessment of Extractables - A Toxicological Window of Opportunity
  • BPOG's Leachables Best Practice Guide: Study Design and Analytical Methods
  • Challenges & Consequences for the Medical Device Industry by the Revision of Three Major ISO 10993-Standards
  • Extractables Screening of Polyproylene Resins for the Identification of Suitability for Use Hazards
  • Clearance of E&L from Single-Use Technologies through Ultrafiltration/Diafiltration
  • Leachable Risk Assessment of Dosing Devices for Parenteral Applications
  • Extractables & Leachables Studies on Single-Use Components in Biomanufacturing
  • Addressing Challenges with Polysorbate 80
  • E&L Test Methodologies for Lyophilized Drug Products
  • Industry Working Group Updates: PQRI & BPOG
  • And More!

Transdermal and Intradermal Drug Delivery Systems, 2016

Advanced Design, Development, and Delivery of Skin-Mediated Therapies and Vaccines

September 12-13, Racquet Club of Philadelphia, PA

The growing interest in alternative routes of drug administration has experts predicting that the market for transdermal and intradermal drug delivery systems will exceed $30 billion in 2016. The industry is on the threshold of bringing into commercial production a new generation of transformative TDD and IDD therapies and delivery systems. That is why you cannot afford to miss this two-day intensive conference. Pharma Ed brings together leading researchers in the field to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.

Over 16 Featured Speakers, Including:

  • Bobby Singh, Chief Technology Officer, Corium -- Keynote Presentation
  • Lisa Dick, MTS Platform Manager, 3M Drug Delivery Systems
  • Ajay Banga, Professor, Mercer Univ.
  • Narasimha Murthy, Assoc. Prof., Ole Miss
  • Audra Stinchcomb, CSO, F6 Pharma
  • Harvinder Gill, Assoc. Prof., Texas Tech University
  • Yash Kapoor, Assoc. Principal Scientist, Merck
  • Mikolaj Milewski, Assoc. Principal Scientist, Merck
  • Helen Quinn, Research Fellow, Queen's University

With Comprehensive Coverage on:

  • Case Studies: Phase I & Phase II Clinical Trials using Passive TD and Microneedle Technology
  • Modeling and Simulation of In Vivo Absorption of Large Molecules for ID Delivery
  • Bioavailability Considerations for TDDS
  • Key Regulatory Issues for TDDS & IDDS, including Recent FDA & USP Guidance Documents
  • Key Formulation Considerations for Skin-Mediated Therapies and Vaccines
  • Latest Advances in Microneedle Patches for Self-Administered Vaccinations
  • Optimizing TDD & IDD for Efficacious Delivery and Patient Compliance
  • Enhancement of Skin Permeation Using Supersaturation
  • Expanding the Range of Compounds for Use in TDD & IDD
  • Effects of Hypothermia in TDD
  • Lowering Production Costs for TDD & IDD Therapies and Vaccines
  • Mechanisms of Dermal and Transdermal Absorption of Drugs
  • And More!

Cleaning Validation Summit 2016

May 23-24, 2016, Racquet Club of Philadelphia, PA

Are you compliant with FDA requirements for cleaning 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.

Featuring Representation From:

  • Bristol-Myers Squibb
  • ValSource
  • Hospira
  • Pharmatech Associates
  • MedImmune
  • Hyde Engineering
  • Steris
  • CPCI
  • Astellas Pharma

Featuring Comprehensive Coverage On:

  • Ensuring your Cleaning Program is FDA Audit Ready
  • Cleaning Validation and Continued Process Verification
  • Risk-Based Approaches to Cleaning Systems Design, Qualification and Ongoing Monitoring
  • Cleaning Limits and Visual Inspection from the Analytical Perspectives
  • Determine Cleanability and its Applications in Cleaning Validation
  • Process Validation & Cleaning Strategies during Technology Transfer of Sterile Injectables
  • EU GMP Changes and Its Impact on Cleaning Validation
  • Quality by Design for Effective Cleaning Procedure
  • Writing Cleaning Validation SOPs
  • And Much More!

Extractables, Leachables, & Elemental Impurities

April 18-19th, 2016, Sheraton La Jolla, California

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of USP and ICH guidelines. This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, parenteral drug products, and infusion pump systems. We will hear from key industry working groups such as PQRI and BPOG. 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.

Featuring Comprehensive Coverage On:

  • Updates & Case Studies on the Latest Compliance Implications of USP and ICH Guidelines for Elemental Impurities
  • Development and Justification of a Risk Evaluation Matrix to Guide Testing Necessary to Select and Qualify Plastic Components used in Production Systems for Pharmaceutical
  • Systematic Extractable Risk Assessment of Polymeric Product Contact Materials in the Manufacturing and Packaging of Biologics
  • Materials Characterization and Extractables and Leachables: Designing and Executing Studies
  • Safety Assessment of Leachables
  • Managing the Risks of Leachables from Single-Use Processing Equipment
  • Extractables & Leachables Considerations in the Qualification and Validation of Single-Use Systems
  • An Approach for E&L Evaluations of High Risk Infusion Devices
  • Practical Approaches for Extractables/Leachables Study and Toxicological Assessment for Printing Inks for Large Volume Parenteral Drug Products
  • And Much More!

2016 Pre-Filled Syringes Forum

Strategic Development, Safety & Regulatory Compliance, and Commercialization of Pre Filled Syringes

April 4-5, 2016, Racquet Club of Philadelphia, PA

Pharma Ed Resources, an industry leader since 2004 in delivering market-driven research on pre-filled syringes, is proud to announce its 2016 Pre-Filled Syringes Forum. With the global market for PFS expected to top $6.5 billion dollars by 2020, the biopharmaceutical industry is looking for next generation materials, technologies and production strategies to streamline commercialization and to adapt quickly to a changing regulatory environment. That is why you cannot afford to miss this intensive two-day training event. Pharma Ed brings together top researchers and innovators to share best practices and the latest science, enabling you to maximize your organization's leverage in this dynamic and growing market.

Featuring Representation From:

  • Pfizer
  • AbbVie
  • Lilly
  • Sanofi Pasteur
  • BioNTech
  • Terumo
  • Bosch Inspection
  • Ypsomed AG
  • West
  • Zeon Chemicals
  • Datwyler
  • ICP Consulting
  • Daikyo Crystal Zenith
  • Material Needs Consulting
  • Eakins & Associates
  • Schott Pharmaceutical Packaging
  • RapID

Featuring Comprehensive Coverage On:

  • A PFS Case Study: FDA Warning Letter for a Combination Product
  • Key Factors in Combination Product Development: Regulatory Hurdles in Receiving PFS and Pen Approvals for Human Factors Studies
  • Next Generation Materials & Design of Pre-Filled Syringes
  • Finite Element Analysis Modeling Applications to PFS and Autoinjector System Design
  • Improving Quality and Cost Control Through Fully Automated Manufacturing of Customized Disposable Pen and Autoinjector Devices
  • Fully Automated, Semi-Automated, and Manuel Inspection Technologies for Safety and Quality in PFS Manufacturing
  • Update on USP's General Chapters Revisions on Packaging Components for Pre-filled Syringes
  • A Complete E&L Qualification Case Study of New Label on Plastic PFS
  • Managing the Materials used to Construct Pre-Filled Syringes: Selection and Supply Chain Control
  • Overcoming Complex Requirements for Biologic Drug Delivery
  • And Much More!

Solubility & Bioavailability Summit 2015

Exploring New Strategies for Optimizing Bioavailability of Current and Future Drug Products

November 5-6, Racquet Club of Philadelphia, PA

Perhaps the most critical research agenda for today's pharmaceutical industry is achieving solubility and bioavailability of poorly soluble drug candidates. The challenges are not going away, and neither are your organization's demands. Pharma Ed's 3rd annual Solubility & Bioavailability Summit focuses on the innovative science required to overcome bioavailability/solubility challenges for API's in a wide range of pre-clinical, clinical, and manufacturing contexts.

Featuring Representation From:

  • Bristol-Myers Squibb
  • Pfizer
  • Novartis
  • AbbVie
  • Astra Zeneca
  • Merck
  • Bend Research
  • Pion
  • Capsugel
  • Quotient Clinical
  • Agios
  • Cempra Pharmaceuticals
  • Sirius Analytical
  • Nanocopoeia
  • Princeton University
  • New Jersey Institute of Technology

With Comprehensive Coverage On:

  • Computational Approaches to Enhanced Solubility
  • Novel In-Vitro Tools to Predict the Food Effect on Bioavailability
  • Encapsulation and Controlled Release from Nanoparticles
  • Implications of Drug/Polymer Interactions at Water/Crystal Interfaces
  • Polymer Thin Films for the Delivery of Poorly Soluble Drugs
  • Risk-Based Approaches in Early Product Design
  • Formulation, Development and Stabilization of Spray-Dried Dispersions
  • Stabilizing Supersaturated Systems Using Surfactants as Anti-Nucleation Agents
  • New Approaches to the Interplay of Dissolution, Solubility and Permeability in Formulation Dev.
  • Dosage Form Selection and Optimization in Early Clinical Trials
  • ational Formulation Approaches to Cost-Effective Product Development
  • And Much More!

Transdermal and Intradermal Drug Delivery Systems, 2015

May 11-12, 2015, Racquet Club of Philadelphia, PA

The growing interest in alternative routes of drug administration has experts predicting that the market for transdermal and intradermal drug delivery systems will exceed $30 billion in 2015. That's why you cannot afford to miss this two-day intensive conference. Pharma Ed brings together leading researchers in the field to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.

Over 15 Featured Speakers, Including:

  • Thean Yeoh, Assoc. Research Fellow, Pfizer
  • Mikolaj Milewski, Sr. Scientist, Merck
  • Ajay Banga, Professor, Mercer Univ.
  • Narasimha Murthy, Assoc. Prof., Ole Miss
  • Susan Ciotti, Dir. Of Formulations, NanoBio
  • Audra Stinchcomb, CSO, F6 Pharma
  • Bobby Singh, Chief Technology Officer, Corium
  • Thakur R.R. Singh, Professor, Queens Univ.

With Comprehensive Coverage on:

  • Key Formulation Considerations for Skin-Mediated Therapies and Vaccines
  • Latest Advances in Microneedle Patches for Self-Administered Vaccinations
  • Optimizing TDD & IDD for Efficacious Delivery and Patient Compliance
  • Understanding Regulatory Requirements for Product Quality and Performance Testing, Including the New Proposed Changes to USP General Chapter <3>
  • Novel TD Patch Designs and Technologies
  • Enhancement Techniques for Drug Delivery and Efficacy
  • Designing the Future: Dissolvable Polymeric Microneedle Arrays
  • Overcoming Barriers to Large Molecule Delivery and Expanding the Range of Compounds for Use in TDD & IDD
  • Lowering Production Costs for TDD & IDD Therapies and Vaccines
  • Mechanisms of Dermal and Transdermal Absorption of Drugs
  • Development of a Novel Antimicrobial Nanoemulsion Therapy
  • Disposal of Transdermal Patches Containing Abuse Potential Drugs
  • Case Study: Phase Two Study of Transdermal Patch Delivering Abaloparatide for Treatment of Osteoporosis
  • And more!

Solubility & Bioavailability Summit 2014

Exploring New Strategies for Optimizing Bioavailability of Current and Future Drug Products

December 4-5, Racquet Club of Philadelphia, PA

Perhaps the most critical research agenda for today's pharmaceutical industry is achieving solubility and bioavailability of poorly soluble drug candidates. The challenges are not going away, and neither are your organization's demands. Pharma Ed's Solubility & Bioavailability Summit focuses on the innovative science required to overcome bioavailability/solubility challenges for API's in a wide range of pre-clinical, clinical, and manufacturing contexts.

Featuring Representation From:

  • Bayer
  • Bristol-Myers Squibb
  • AbbVie
  • Novartis
  • Ipsen BioScience
  • Astra Zeneca
  • Merck
  • Capsugel
  • Quotient Clinical
  • Kashiv Pharma
  • Pion
  • Sirius Analytical
  • H. Lundbeck
  • NIST
  • University of Limerick
  • Gattefossé
  • Center for Pharmaceutical Physics
  • Agere
  • University of the Sciences in Philadelphia

Featuring Comprehensive Coverage On:

  • Optimizing Formulations for New Drug Product Development
  • Peptide Formulation Challenges and Beyond
  • De-risking New Chemical Entities for Food- and pH-Sensitivity in Early Clinical Development
  • Key Formulation Considerations for Suspensions of Amorphous Dispersions
  • Studying the Interplay of Dissolution, Solubility and Permeability in Formulation Development
  • Re-conceptualizing Solubility & Bioavailability for Today’s API Challenges
  • Using Ion Pair Formation to Enhance Solubility
  • Unique Properties of Lipid-Based Formulations & Keys of Design and Testing
  • Surface-facilitated Polymorphic Transformation (SurFPT)
  • Spray-dried Technologies for Amorphous Stabilization of Poorly Soluble Compounds
  • Fresh Research on Co-Crystals and their Impact on Bioavailability
  • And Much More!

Lyophilization Forum 2014

Formulation, Cycle Optimization, & Emerging Drying Technologies

October 20-21, Racquet Club of Philadelphia, PA

Featuring Representation From:

  • Pfizer
  • Merck
  • Novartis
  • Baxter
  • Medimmune
  • SP Scientific
  • Novo Nordisk
  • Lyophilization Technology
  • GEA Lyophil
  • Ima Life
  • West
  • Millrock Technology
  • AB BioTechnologies
  • LIGHTHOUSE Instruments
  • NIBSC
  • PSD, Inc
  • NIST
  • LifeCell

Featuring Comprehensive Coverage On:

  • Case Studies in Controlled Nucleation
  • Stabilization and Drying Techniques for Complex Proteins & Biologics
  • Developing a Lab-scale Model for Life-cycle Management of a Marketed Vaccine
  • Creating a Design Space for Secondary Drying
  • Clinical & Commercial Tech Transfer: Reducing Risk of Freeze-drying Failure Through Freeze Dryer Characterization & Modeling
  • DoE Approaches within Lyophilization Formulation & Process Development
  • Predicting the Stability of Lyophilized Sugar Glasses by Fluorescence Stokes Shift
  • QbD and PAT in Developing a Spray Drying Process
  • Understanding Phase Behavior of Ice During Lyophilization
  • Lyophilized Drug Product Development using QbD Principles
  • Product Behavior During Lyo when Processed in Dual Chamber Cartridges vs. Tubing Vials
  • Freeze Drying PAT using Heat Flux Measurement
  • Spray Drying Challenges-Lab Scale Formulation to Pilot Scale Up
  • Container Closure Systems for Optimal Lyophilized Product Stability & Processing
  • Moisture Monitoring, Inspection, & Tracing Methods for Lyophilized Vials
  • And Much More!

Extractables, Leachables, & Elemental Impurities - West Coast

Ensuring Quality, Safety, and Regulatory Compliance for Drugs & Biologics

September 15-16, 2014, Sheraton La Jolla, CA

Featuring Representation From:

  • FDA
  • Bristol-Myers Squibb
  • Eli Lilly & Co.
  • Janssen R&D - A Pharmaceutical Company of Johnson & Johnson
  • Amgen
  • Boehringer Ingelheim
  • West Pharmaceutical Services
  • BD
  • Baxter Healthcare Services
  • B. Braun Medical
  • VR Analytical
  • Bausch+Lomb
  • Fresenius Kabi
  • Exova
  • Toxikon
  • Aspen Research
  • Eakins & Associates
  • Material Needs Consulting

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of USP and ICH guidelines. This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, parenteral drug products, and infusion pump systems. We will hear from key industry working groups such as PQRI and BPOG. 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.

Featuring Comprehensive Coverage On:

  • Meeting Qualification and Compliance Implications of USP and and ICH Guidelines for Elemental Impurities
  • Industry Working Group Updates: The PQRI Leachables and Extractables Considerations for Parenteral and Ophthalmic Drug Products
  • Industry Working Group Updates: The BPOG's Extractables Protocols for Singe-Use Technologies
  • Total and Extractable Elemental Impurities In Plastic Materials and Systems: A Literature Review
  • Analysis of Extractables & Leachables: Past, Present and Future Trends
  • Extractable Study Design and Data Evaluation of Polymeric Product Materials
  • Safety Assessment of Leachables for Parenteral Drug Products
  • Managing the Risks of Leachables from Single-Use Processing Equipment
  • Strategic Application of Analytical Methods for Extractables Evaluations
  • Extractables & Leachables Considerations in the Qualification and Validation of Single-Use Systems
  • E/L Studies for Medical Devices Based on Blood Separation Technologies
  • And Much More!

7th Annual Pre-Filled Syringes Forum

Strategic Development, Safety & Regulatory Compliance, and Commercialization of Pre-Filled Syringes

May 19-20, 2014, Racquet Club of Philadelphia, PA

Join industry innovators and key decision-makers in exploring the latest research into pre-filled syringes and other parenteral drug delivery systems.

Featuring Representation From:

  • Amgen
  • Datwyler
  • Baxter
  • Vetter Pharma
  • BD
  • Ompi
  • Lyophilization Technology, Inc
  • Toxikon
  • NSF Health Sciences
  • Noxilizer
  • Si02
  • Material Needs Consulting
  • Bosch Packaging
  • Eakins & Associates
  • Bosch Inspection
  • Zeon Chemicals
  • West Pharmaceutical Services

Featuring Comprehensive Coverage On:

  • Strategic Development & Design Considerations for Pre-Filled Syringes
  • Key Regulatory Issues Related to the New USP Chapters for Plastic and Glass Container Closure Systems
  • Pre-Filled Syringe Manufacturing: A Review of Processes and Challenges
  • Linking Technology with Patient Centric Design in PFS Product Development
  • Extracting and Quantifying Elemental Tungsten from Pre-Filled Syringes
  • Extractables & Leachables Considerations for Drug-Filled Implantable Devices & Pre-Filled Syringes
  • Comparison of Product Behavior During Lyophilization When Processed in Dual Chamber Cartridges and Tubing Vials
  • Sterilization Solutions for Pre-Filled Syringes
  • Aseptic Transfer of Pre-Filled Syringes
  • And Much More!

Extractables, Leachables, & Elemental Impurities 2014

Ensuring Quality, Safety, and Regulatory Compliance for Drugs & Biologics

March 24-25, Philadelphia, PA

Featuring Representation From:

  • FDA
  • USP
  • Merck
  • Eli Lilly & Co.
  • Janssen R&D-A Pharmaceutical Company of Johnson & Johnson
  • NSF Health Sciences
  • Boehringer Ingelheim
  • Bausch+Lomb
  • BD
  • Aspen Research Corporation
  • West Pharmaceutical Services
  • Baxter Healthcare Services
  • Forest Laboratories
  • Novo Nordisk
  • Fresenius Kabi
  • Exova
  • Toxikon
  • Eakins & Associates
  • Material Needs Consulting

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of EMA, USP, and ICH guidelines. This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, parenteral drug products, and infusion pump systems. In addition, we will also focus closely on the keys to satisfying recent ICH, USP, and EMA guidelines for metal impurities in current and future drug products and biologics.

Featuring Comprehensive Coverage On:

  • Meeting Qualification and Compliance Implications of USP <232> and <233>, ICH, and EMA Guidelines for Elemental Impurities
  • Industry Working Group Update: The PQRI Leachables and Extractables Considerations for Parenteral and Ophthalmic Drug Products
  • Total and Extractable Elemental Impurities In Plastic Materials and Systems: A Literature Review
  • Analysis of Extractables & Leachables: Past, Present and Future Trends
  • Extractable Study Design and Data Evaluation of Polymeric Product Materials
  • Safety Assessment of Leachables for Parenteral Drug Products
  • Extractables & Leachables from Infusion Pump Systems
  • Managing the Risks of Leachables from Single-Use Processing Equipment
  • Use of Simulation Studies to Support Change Control in Ophthalmic Packaging Systems
  • Extractables & Leachables Considerations in the Qualification and Validation of Single-Use Systems
  • E/L Studies for Medical Devices Based on Blood Separation Technologies
  • And Much More!

Solubility Summit 2013

Exploring New Strategies for Optimizing Solubility & Bioavailability of Current and Future Drug Products

December 5-6, Philadelphia, PA

Featuring Representation From:

  • Novartis
  • Aptuit
  • Merck
  • Quotient Clinical
  • GlaxoSmithKline
  • Sirius Analytical
  • Roche
  • Celgene
  • Capsugel
  • Patheon
  • Agios
  • Takeda
  • Pion
  • Cubist
  • H. Lundbeck
  • Agere
  • Center for Pharmaceutical Physics

Join industry innovators and key decision-makers to explore the latest research into solubility and bioavailability. Featured case studies include:

  • Optimizing Formulation and Product Development in Early Clinical Research
    -Presentation by Jason Vaughn, Patheon
  • Nanosuspension Formulation and Process Optimization for Improved Bioavailability of Poorly Soluble Drug Compounds
    -Presented by Indrajit Ghosh, Celgene
  • Successful Formulation Strategies for Amorphous Solid Dispersions
    -Presented by Duk Soon Choi, Roche
  • Role of Small Molecule Colloid Formation on Oral Absorption
    -Presented by Liping Zhou, Novartis
  • Effects of Manufacturing Process on Solid Dispersion Stability and Bio-Performance
    -Presented by Michael Lowinger, Merck
  • Adapting QbD Principles to Solubilization Formulation Development
    -Presented by Marshall Crew, Agere Pharmaceuticals
  • Amorphous Spray-Dried Dispersions in Early Phase Development
    -Presented by Pratik Saha, GlaxoSmithKline

And many more! Including special coverage on:

  • Intellectual Property Considerations for Solid Form Drug Compounds
  • Supersaturation & Precipitation Behavior of Poorly Soluble Drugs
  • Rational Formulation Design for Poorly Soluble Drugs
  • Co-Crystallization Techniques to Optimize Solubility
  • Innovations in Discovery Pharmaceutics for Poorly Soluble Compounds
  • Recent Developments in Lipid-Based Drug Delivery
  • Considerations for Toxicology Formulations of Poorly Soluble Compounds

LYOPHILIZATION FORUM, 2013

Formulation, Cycle Optimization, & Regulatory Compliance

November 7-8, Philadelphia, PA

Featuring Representation From:

  • Pfizer
  • Novartis
  • Merck
  • Genzyme
  • Baxter
  • SP Scientific
  • GEA Lyophil
  • Cureport
  • West
  • AB Bio Tech
  • NIBSC
  • Steris
  • Lyophilization Technology, Inc.
  • Ima Life
  • Novo Nordisk
  • The Linde Group
  • Xavier University of Louisiana, College of Pharmacy
  • Lyophilization Services of New England

PRE-FILLED SYRINGES FORUM 2013

Strategic Development, Inspection, Safety & Regulatory Compliance and Commercialization of Pre-Filled Syringes

June 6-7, 2013, Racquet Club of Philadelphia, PA

Featuring Case Studies and Lessons Learned from Industry Experts!

  • Materials, Design & Construction of Pre-Filled Syringes
  • Safety Considerations & Requirements
  • Numerous Development Case Studiess
  • Manufacturing & Filling Solutions
  • Regulation & Inspection of Pre-Filled Syringes
  • Future Materials for Pre-Filled Syringe Components

Featuring Representation From:

  • Abbott
  • Bosch
  • Pfizer
  • Baxter
  • Eisai Machinery USA, Inc.
  • Kiang Consultant Services
  • SKAN US, Inc.
  • West Pharmaceutical Services, Inc.
  • STELMI
  • BD Technologies
  • Vetter
  • Eakins and Associates
  • Biologics Consulting Group
  • Zeon Chemicals L.P.
  • Trotter Biotech Solutions
  • WILCO
  • Gerresheimer
  • Bonfiglioli Engineering S.p.A.

DISPOSABLES & SINGLE-USE BIOPHARMACEUTICAL MANUFACTURING SYSTEMS:

Understanding the Advantages, Costs, Regulatory and Process Considerations in the Usage of Disposables and Single-Use Systems

July 30-31, 2012, Radisson-Plaza Warwick, Philadelphia, PA

  • Understanding the Advantages and Benefits of Disposable and Single-Use Systems
  • Regulatory Compliance: Requirements for Disposable and Single-Use Systems
  • QC Documentation, Calibration and Irradiation Requirements
  • Reducing Contamination Risk Through the Use of Disposables and Single-Use Systems
  • Operational Considerations When Using Disposable and Single-Use Systems
  • Assessing and Qualifying Vendors of Disposable and Single Use Components
  • Extractables and Leachables Considerations and Strategies for Testing
  • Cost Considerations in the Usage of Disposable and Single-Use Systems

TRANSDERMAL DRUG DELIVERY SYSTEMS

Examine Recent Developments in Transdermal Drug Delivery

March 15-16, 2012, Racquet Club of Philadelphia, PA

  • Practical Considerations for Expanding the Range of Drugs and Vaccines for Delivery Using Transdermal Systems
  • Explore Transdermal Drug Delivery Systems as a Viable Alternative to Oral, p;Intra-Muscular;or Intra-venous Injection
  • Understand How FDA Regulates Transdermal Drug Delivery Technologies for Investigational and Marketed Products
  • Explore Novel Applications of Transdermal Drug Delivery Technologies
  • Overcome Obstacles and Achieve Efficacy in Active Transdermal Delivery Platforms
  • Cost Considerations in the Development and Production of Transdermal Delivery Systems
  • Understand Therapeutic Advantages for Transdermal Delivery of Biopharmaceutical and Vaccines
  • Learn How New Technologies are Expanding the Scope of Transdermal Delivery to Include Hydrophilic Macromolecules

PRE-FILLED SYRINGES FORUM 2012

Strategic Development, Inspection, Safety & Regulatory Compliance and Commercialization of Pre-Filled Syringes

March 15-16, 2012, Racquet Club of Philadelphia, PA

Featuring Case Studies and Lessons Learned from Industry Experts!

  • Materials, Design & Construction of Pre-Filled Syringes
  • Safety Considerations & Requirements
  • Numerous Development Case Studiess
  • Manufacturing & Filling Solutions
  • Regulation & Inspection of Pre-Filled Syringes
  • Future Materials for Pre-Filled Syringe Components

Featuring Representation From:

  • Abbott
  • Bosch
  • Pfizer
  • Baxter
  • Eisai Machinery USA, Inc
  • Kiang Consultant Services
  • SKAN US, Inc.
  • West Pharmaceutical Services, Inc.
  • STELMI
  • BD Technologies
  • Vetter
  • Eakins and Associates
  • iologics Consulting Group
  • Zeon Chemicals L.P.
  • Trotter Biotech Solutions
  • WILCO
  • Gerresheimer

EXTRACTABLES & LEACHABLES

October 10-11, 2011, RADISSON-PLAZA WARWICK, PHILADELPHIA, PA

Topics to be addressed include:

  • Explore Materials Used to Fabricate Container Closure Systems and the Impact on Extractables and Leachables
  • E&L Considerations in the Qualification and Validation of Single-use Systems
  • Development and Validation of Analytical Methods for Analysis of Organic Leachables in Drug Products
  • Current Extractables/Leachables Thinking: Impact on the E&L Approach of an Elastomeric Closure Supplier
  • Replacement of Controlled Extraction Studies for PODP E&L Documentation
  • Detection of Glass Particles, Flakes or Lamellae in Tubular Glass Vials

Plus

In-Depth Pre-Conference Workshop:

Regulatory Considerations for Extractables and Leachables
~ Dennis Jenke, Ph.D., Principal Scientist, Technology Resources Division, Baxter Healthcare Corporation

Representation from:

  • Baxter Healthcare Corporation
  • Helvoet Pharma
  • Material Needs Consulting, LLC
  • Merck and Company
  • Novo Nordisk A/S
  • NSF Pharmalytica
  • Pall Life Sciences
  • Rumpler Technologies
  • Solvias AG
  • Eakins and Associates
  • Vanasyl LLC
  • WEST Pharmaceuticals

PROCESS VALIDATION 2011

Managing Process Validation Activities to Efficiently Meet Compliance Expectations

JUNE 23-24, 2011, RADISSON-PLAZA WARWICK, PHILADELPHIA, PA

  • Implementing a Science and Risk-Based Approach to Commissioning and Qualification in Line with the FDAís Recent Process Validation Guidance
  • Risk-Based Validation and Re-qualification of Process & Equipment
  • Stability Considerations in Process Validation
  • A Roadmap for Implementing the New Process Validation Guidance
  • Best Practices for Defining and Executing a Cleaning Validation Program
  • Defining the Design Space for Cleaning Validation, Cleaning Process Qualification, and the Continued Verification of a Validated Cleaning Process
  • Implementing A System for Continued Process Verification
In Depth Coverage: Understanding FDA's New Process Validation Guidance: Assess Challenges Associated With the Interpretation and Implementation of the Guidance

PRE-FILLED SYRINGES FORUM 2011

Strategic Development, Inspection, Safety & Regulatory Compliance and Commercialization of Pre-Filled Syringes

March 10-11, 2011, Crowne Plaza, Philadelphia, PA

Featuring Case Studies and Lessons Learned from Industry Experts!

  • Materials, Design & Construction of Pre-Filled Syringes
  • Safety Considerations & Requirements
  • Numerous Development Case Studies
  • Manufacturing & Filling Solutions
  • Regulation & Inspection of Pre-Filled Syringes
  • Future Materials for Pre-Filled Syringe Components

Featuring Representation From:

  • Eakins and Associates
  • Bosch
  • Biologics Consulting Group
  • Eisai Machinery USA, Inc.
  • Kiang Consultant Services
  • SKAN US, Inc.
  • West Pharmaceutical Services, Inc.
  • Material Needs Consulting, LLC
  • Vetter Pharma-Fertigung GmbH
  • Helvoet Pharmaceutical
  • Schott North America, Inc.
  • Zeon Chemicals L.P.
  • Ypsomed AG
  • Trotter Biotech Solutions
  • Schreiner MediPharm, LP
  • Gerresheimer

TRANSDERMAL DRUG DELIVERY SYSTEMS

Examine Recent Developments in Transdermal Drug Delivery

February 24-25, 2011, Radisson Warwick Hotel, Philadelphia, PA

Topics to be Addressed Include:

  • Practical Considerations for Expanding the Range of Drugs and Vaccines for Delivery Using Transdermal Systems
  • Explore Transdermal Drug Delivery Systems as a Viable Alternative to Oral, Intra-Muscular or Intra-venous Injection
  • Understand How FDA Regulates Transdermal Drug Delivery Technologies for Investigational and Marketed Products
  • Explore Novel Applications of Transdermal Drug Delivery Technologies
  • Overcome Obstacles and Achieving Efficacy in Active Transdermal Delivery Platforms
  • Cost Considerations in the Development and Production of Transdermal Delivery Systems
  • Understand Therapeutic Advantages for Transdermal Delivery of Biopharmaceutical and Vaccines
  • Learn How New Technologies are Expanding the Scope of Transdermal Delivery to Include Hydrophilic Macromolecules

Featuring Representation From:

  • Eakins and Associates, Inc.
  • Biologics Consulting Group
  • BD Technologies
  • 3M Drug Delivery Systems
  • University of Mississippi
  • American Association of Pharmaceutical Scientists
  • Xel Pharmaceuticals, Inc.
  • University of Kentucky College of Pharmacy
  • AllTranz Inc.
  • Polytherapeutics, Inc.
  • PATH

CONTAINER CLOSURE SYSTEMS 2010

Strategies for Selection, Compliance and Mitigation of Extractables and Leachables Challenges

November 11-12, 2010, Radisson Warwick Hotel, Philadelphia, PA

Topics Addressed Include:

  • Selecting and Evaluating Materials for Container Closure Systems
  • Reducing the Potential for Interaction Between Dosage and Components of Container Closure Systems
  • Assessing the Influence of Container Closure Systems on Drug Stability
  • Pharmacopeial Control of Plastic Materials for Containers
  • How Custom and Semi-Custom Packages Can Reduce QC and Production Costs and Timing
  • Satisfying Evolving Quality Expectations for Glass Injectable Packaging
  • Determination of Extractables and Leachables for Container Closure Systems
  • Building Efficiencies in Extractables/Leachables Testing in Quality Control Programs
  • Extractables and Leachables Case Studies

Plus, Special Expanded Session:

Evaluating and Selecting Polymeric Materials for Container Closure Systems

Representation From:

  • Genzyme Corporation
  • Kiang Consultant Services
  • Material Needs Consulting, LLC
  • Eakins & Associates
  • West Pharmaceutical Services
  • CCM Specialists
  • Ompi of America
  • Chemic Laboratories, Inc.
  • Pfizer, Inc.
  • Toxikon Corporation
  • Pharmalytica Services
  • SCHOTT forma vitrum
  • LANXESS Inc.

DISPOSABLES & SINGLE-USE BIOPHARMACEUTICAL MANUFACTURING SYSTEMS

Understanding the Advantages, Costs, Regulatory and
Process Considerations in the Usage of Disposables and Single-Use Systems

September 27-28, 2010, Radisson Warwick Hotel, Philadelphia, PA

Key Learning Objectives:

  • Understand the Advantages and Benefits of Disposable and Single-Use Systems
  • Explore and Quantify the Cost Outcomes Managing the Risks Associated with Materials Utilized to Fabricate Single-Use Bio-Processing Equipment
  • Using Single-use Assembliesfor Final Fill and Finish Application
  • Implement a Risk-based Approach to Single Use Systems Implementation
  • Understand FacilityDesign and Equipment Considerations
  • Risk-based Assessment of Extractables & Leachables in Single-use Systems
  • Implement Containment Solutions Under Time & Budget Constraints Using Disposable Technologies

REPRESENTATION FROM:

  • PallLife Sciences
  • AMEC
  • Robert Bosch Packaging Technology, Inc.
  • Biopharm Services Ltd.
  • Hecht Technologies
  • Hyde Engineering + Consulting, Inc.
  • MilliporeCorporation
  • Material Needs Consulting, LLC
  • Vivalis, France
  • Xcellerex

For sponsorship/exhibitor opportunities please contact khubbard@pharmaedresources.com

PRE-FILLED SYRINGES WEST COAST FORUM 2010

Strategic Development, Inspection, Safety & Regulatory Compliance and Commercialization of Pre-Filled Syringes

July 22-23, San Diego, California

Key Learning Objectives:

  • Materials, design & construction of pre-filled syringes
  • Safety considerations & requirements
  • Numerous development case studies
  • Manufacturing & filling solutions
  • Regulation & inspection of pre-filled syringes
  • Future materials for pre-filled syringe components

Including Special Coverage On:

  • Syringe Plunger Movement ∑ Stopper Movements
  • Development Case Studies ∑ Bubble-Free Filling
  • Manufacturing Solutions ∑ Syringe Manufacturing
  • Visual Inspection ∑ Extractables & Leachables
  • Container Closures ∑ Combination Products

Conference includes several exhibitors and product displays. Contact Kim Hubbard at 217-355-7322 for more information!

EXTRACTABLES AND LEACHABLES

Strategies to Ensure Safety and Compliance in the Packaging and Processing of Drugs and Biologics

May 3-4, 2010, Radisson Fishermans Wharf, San Francisco, CA

Featuring Case Studies and Lessons Learned from Industry Experts!
Examine Case Studies and Best Practices for Extractables and Leachables

Manage Extractables and Leachables Resulting from Packaging Materials, Closures and Excipients
Review Toxicology Considerations and Risk Mitigation Strategies

Trace Level Compound Indentification and Extractables and Leachables from Disposable/Single Use Systems

In-Depth Pre-Conference Workshop:

Aligning Safety Assessment and Product Development Activities to Reduce the Risks Associated with Extractables and Leachables: A Case Study Review
Dennis Jenke, Ph.D, Principal Scientist, Physical and Chemical Sciences, Baxter Technology Resources

Featuring Representation From:

  • Baxter Healthcare Inc.
  • Baxter Technology Resources
  • Becton Dickinson
  • Boehringer Ingelheim Pharmaceuticals, Inc.
  • Human Genome Sciences
  • Hyprotek, Inc.
  • Material Needs Consulting, LLC
  • Pall Life Sciences
  • Pfizer, Inc.
  • Pharmalytica Services
  • TOXIKON
  • West Monarch Analytical Laboratories

NOW ACCEPTING POSTER PRESENTATIONS. Please contact khubbard@pharmaedresources.com

QUALITY BY DESIGN (QbD)

A hands-on two day workshop covering the key components of QbD concepts, implementation and product risk mitigation.

March 4-5, 2010 - Radisson-Warwick Hotel, Philadelphia, PA

Key Learning Objectives:

  • Understand Risk-Based GMP Compliance and FDA, ICH and ASTM Approaches
  • Review Strategies for Defining Risk, Risk Factors and Risk Prioritization
  • Understand the Basic Fundamentals and Approach of QbD
  • Use QbD to Mitigate Product Risk in Engineering Drug Manufacturing Operations
  • Understand the Connection Between QbD and Process Analytical Technology (PAT)
  • Implement the Concept of Continuous Improvement
Including Multiple Interactive Exercises and Case Study Examples!

CONTAINER CLOSURE SYSTEMS 2010

Strategies for Selection, Compliance, and Mitigation of Extractables and Leachables Challenges

January 25-26,2010, Radisson Warwick Hotel, Philadelphia, PA

Key Learning Objectives:

  • Understanding the Unique Container Closure System Considerations and Requirements for Various Drug Products
  • Determining the Presence of Extractables and Leachables
  • Understanding Testing Requirements for Container Closure Systems
  • Evaluating and Selecting Materials for Container Closure Systems
  • Developing Internal Quality Control Programs For Container Closure Systems
  • Innovations in Container Closure Systems and New Industry Technologies

Special In-Depth Session:

Evaluating and Selecting Polymeric Materials for Container Closure Systems

Featuring Representation From:

  • BD Medical Pharmaceutical Systems
  • Eakins & Associates
  • Eli Lilly & Company
  • Helvoet Pharmaceuticals
  • Hyaluron
  • Linda A. Walker Consulting, LLC
  • Material Needs Consulting, LLC
  • NAMSA
  • Packaging Science Resources, Inc.
  • Phase Technologies, Inc.
  • West Pharmaceuticals
  • Whitehouse Analytical Laboratories, LLC

OUTSOURCING MANUFACTURING

January 25-26,2010, Radisson Warwick Hotel, Philadelphia, PA

Key Learning Objectives:

  • Understand Supplier and Customer Issues in Outsourcing Relationships
  • Learn Strategies for Making the Decision to Outsource
  • Know How to Identify the Right Supplier for your Particular Outsourcing Need
  • Understand How to Conduct Supplier Audits
  • Learn Strategies for Awarding Projects and Engaging your Suppliers
  • Understanding Technology Transfer Considerations for Successful

“"A fantastic meeting. I was interested in so many of the talks and I met several clients-current and potential.” - Principal Scientist, Aptuit SSCI

“I really enjoyed the meeting . . . Stronger speakers and more in depth coverage than some of the others on the market.”- Director, Emerson Resources, Inc.

“Thank you again for such an excellent program – it was very informative and enjoyable.” - Senior Principal Scientist, Bausch + Lomb

“I go to a lot of conferences, and this was an excellent one.” - A senior scientist at Boehringer Ingelheim

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