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Extractables, Leachables & Elemental Impurities 2018 - West Coast

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

November 13-14, Sheraton La Jolla, CA

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:

  • Pfizer
  • Merck
  • Janssen
  • Sanofi
  • VR Analytical
  • Intertek
  • Pall
  • Jordi Labs
  • Agilent
  • West Pharmaceutical Services
  • EKG Labs
  • Almac
  • Toxikon
  • Material Needs Consulting
  • Exova
  • Triad
  • SGS
  • IQC
  • Nelson Labs

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!
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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 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 AG
  • PTI
  • Datwyler
  • Toxikon
  • Bosch
  • West
  • Eakins & Associates
  • Harro Holfinger
  • Unchained Labs
  • GessNet

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

Early Bird Special: Register by September 30th for only $1,295!

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Upcoming Events

Data Integrity and Pharmaceutical Quality Compliance- March 4-5

Boston, MA

Extractables, Leachable and Elemental Impurities- May 2nd and 3rd

Boston, MA

Inhalation Drug Delivery Systems- May 28th and 29th

Boston, MA

Transdermal Drug Delivery Systems- September 11th and 12th

Boston, MA

Cleaning Validation- September 26th and 27th

Boston, MA

Wearable Injectors- October 10th and 11th

Boston, MA

Cannabis and the Pharma Industry- October 24th and 25th

San Diego, California

Process Validation-October 3rd and 4th

Boston, MA

Tenative Pre-Filled Syringes repeat in San Diego in mid-November

Boston, MA

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.

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

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- 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