Featured Events!

Pharma Analytics Summit

Statistical Approaches for Improving Performance and Compliance

March 26-27, 2018, Racquet Club of Philadelphia, PA

Use of statistics has been part of the FDA’s guidances and regulations for many years. Use of statistics is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Are you compliant with FDA requirements? 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:

  • Eli Lilly
  • SynoloStats
  • Snee Associates LLC
  • JnJ Vision Care
  • Upsher-Smith Laboratories
  • Apotex
  • Janssen
  • Insight, Advice and Solutions, LLC
  • Excellent Pharma Consulting
  • Catalent Biologics
  • Zinata

With Comprehensive Coverage On:

  • Solving Statistical Mysteries – What Does the FDA Want?
  • Stability and Capability of Measurement System and Manufacturing Process is Fundamental to Pharmaceutical Quality Assurance in the 21st Century
  • Strategies forAccelerating Process and Formulation Validation
  • Measurement Systems Analysis and Some Useful Experimental Designs
  • Continued Process Verification and Fit for Use Statistical Approaches
  • The Need for both Fundamental and Advanced Understanding to Design Lean Statistical Approaches
  • Test Method Robustness/Design Space
  • And Much More!

Extractables, Leachables & Elemental Impurities 2018

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

March 28-29, Racquet Club of Philadelphia, PA

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:

  • FDA
  • Johnson & Johnson
  • Pfizer
  • Merck
  • Eli Lilly & Co
  • Sanofi
  • Pall
  • Jordi Labs
  • Agilent
  • West Pharmaceutical Services
  • EKG Labs
  • Almac
  • VR Analytical
  • Toxikon
  • SGS
  • Triad
  • Material Needs Consulting
  • Intertek
  • Akorn Pharmaceuticals

Featuring Comprehensive Coverage On:

  • Key Issues in Satisfying ICH Q3D, and USP Guidelines Regarding Elemental Impurities (EI)
  • Update on revised USP for Materials and Components used in Pharmaceutical Manufacturing Systems
  • Update on Revision of USP, for Plastic Material Components and Packaging Systems
  • Update on revised USP for EI and Extractables for Elastomeric Enclosures in Injectable Devices
  • Analytical Challenges in Extractable and Leachable Studies of Pre-Filled Syringes for Oil-Based Drug Formulations
  • PQRI Thresholds and Best Practices for E&L for Biologics
  • Designing and Improving Risk-Based Assessment of E&L Data for Drugs, Biologics, and Medical Devices
  • E&L Considerations in the Qualification and Validation of Single-Use Systems
  • Toxicology Assessment Approaches for E&L Studies
  • E&L for Oral Dosage Forms
  • Addressing Extractables & Leachables from Bioprocessing Equipment & Product Packaging
  • And More!

Event Sponsors:

2018 Pre-Filled Syringes Forum

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

April 3-4, 2018, 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 2018 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
  • rapID
  • Exova
  • PTI
  • Toxikon
  • Datwyler
  • Bosch
  • Airvac
  • Eakins & Associates
  • West
  • Harro Holfinger

Including Special Coverage On:

  • Critical Issues—Examining the Regulatory Environment for PreFilled Syringes & Combination Drug-Delivery Systems
  • Quality and Regulatory Affairs Best Practices for External Partnerships in Combination Product Development
  • Ophthalmic Injections: The Manufacturer, Regulator, Physician, and Patient Ecosystem
  • Applying Quality-by-Design Principles to the Development of Pre-filled Syringes
  • Filling of High-Concentration mAb Formulations into Pre-filled Syringes – Understanding Nozzle Clogging and Filling Accuracy
  • Syringe Siliconization and its Role in Protein Aggregation
  • Pre-filled syringes(PFS) and container closure integrity testing (CCIT)
  • Challenges and Opportunities for Development of Stability Program for Combination Products
  • Devices for Self-Injection: Advantages of the Platform Approach
  • Challenges Associated with PFS Combination Product Development for Ophthalmic Applications
  • Strategic and Technical Considerations for PFS and Autoinjector Development for Biologics
  • And Much More!

Event Sponsors:

Process Validation Summit 2018

May 17-18, Racquet Club of Philadelphia, PA

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:

  • FDA
  • GSK
  • Pfizer
  • Abbott
  • Bayer
  • Q Pharma
  • Steris
  • PharmaTech Associates
  • Parexel
  • SynoloStats
  • Validation Edge
  • Tunnell, LLP
  • Wiley Rein, LLP
  • Compliance Team, Inc.
  • Snee Associates

Featuring Comprehensive Coverage On:

  • FDA Process Validation and Risk Management Approaches
  • Lifecycle Approach to Process Validation
  • Global Technology Transfer and Process Validation
  • Scientific and practical considerations of small scale model qualification and related statistical analyses for biopharmaceutical manufacturing processes
  • 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
  • Assessing the Practical Signi cance of Statistical Study Results
  • Revalidation of Biopharmaceutical Drug Product Manufacturing Process
  • And More!

Upcoming Events

Cleaning Validation Summit- September 12-13, 2018

Philadelphia, PA

Transdermal and Intradermal Drug Delivery Systems, September 17-18, 2018

Philadelphia, PA

Inhalation Drug Delivery Systems- October 8-9, 2018

Philadelphia, PA

Why PharmaEd?

Profitable Networking

Industry innovators and established professionals meet to share ideas, forge relationships, and imagine new opportunities.

Experience You Trust

Our team has over four decades of combined experience producing conferences and delivering real value to the pharma industry.

An Industry Leader

Pharma Ed has collaborated with over 250 companies and organizations to produce some of the most informative meetings in the industry.

Our Mission

To deliver the most current, market-driven information to meet your research, product development, regulatory, quality assurance, and technical needs.

Relevant Training

Cutting-edge knowledge drawn from top pharmaceutical, biotech, and academic experts.

Sponsorship Opportunities!

Sponsor a PharmaEd event and set your business apart!


What People Are Saying About
Pharma Ed Events

"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."
- Sr. Principal Scientist, Bausch + Lomb

"I go to a lot of conferences, and this was an excellent one."
- Sr. Scientist, Boehringer Ingelheim

"Great audience, with good choice of speakers. Would love to attend again."
- Principal Scientist, Pfizer

"I greatly enjoyed the conference. I found the topics relevant and containing great content. I look forward to bringing the knowledge and principles to my role in R&D."
- Manager, CSL Behring

"I was very pleased with the material presented, and the expertise of the presenters. I will be taking much valuable/applicable knowledge back to my company."
- QA Director, Biothera

"Each and every presentation contained information that I found to be useful and relevant and many presentations left me with ideas and concepts that I look forward to considering in greater detail."
- Distinguished Scientist, Baxter

"The presentations & experience of the presenters was very instructive & helpful toward building my programs."
- QA/Corporate Director, Medicago, Inc.

"This is a valuable conference, with many expert speakers."
- Product Manager, EMD Millipore

"I really enjoyed it. I feel engaged and like there is a lot to learn."
- Assoc. Scientist, Bristol-Myers Squibb

"Very good conference with knowledgeable presenters, good feedback, and 'real world' examples/takeaways."
- Assoc. Director of PV, Shire

"Great mix of topics and excellent networking sessions."
- Deputy Director, Sanofi Pasteur

"Very useful conference for us. Learned a lot from all the presentations."
- Scientist I, Amneal Pharmaceuticals

"I am new to the med device E/L scene, so I attended as a learning opportunity and to begin to get up to speed. I feel the conference was very informative and balanced various subject areas as well. I'll definitely plan on attending again."
- Research Toxicologist, NSF International