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April 02, 2020
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   [Webinar] AAV Gene Therapy; A Road Map to IND Submission

The webinar will focus upon the common issues which might delay the IND submission or pre-IND interaction with FDA. We will discuss how to design your in-vitro or in-vivo studies timely and effectively to overcome these issues, with a view toward current regulatory guidelines and the expectations of regulatory agencies.

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» Industry News
 
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» Featured Articles
HORIZON LINES: A Quarterly Review of NDAs – October-December, 2019
This quarterly review of new drug applications contain data for applications approved for the first time during the fourth quarter of 2019 which includes New Molecular Entities (NMEs) and new ... read more »
Facilitating Supply Chain Collaboration with Blockchain Technology
With the introduction of serialization regulations and the prioritization of end-to-end visibility, the digitization of global supply chains is beginning to take center stage. read more »
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» Featured Partners
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  Register Now: Driving Data Integrity in the Right Direction

Data Integrity and Computerized System Validations (CSV) have become an area of increased scrutiny for regulatory agencies over the last several years. Understanding how the agencies view data integrity is critical for laboratories to maintain complete compliance. read more »
» Featured Video
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  Live Webinar: AAV Gene Therapy; A Road Map to IND Submission
The webinar will focus upon the common issues which might delay the IND submission or pre-IND interaction with FDA. We will discuss how to design your in-vitro or in-vivo studies timely and ... read more »
learn more
  Watch Video: Pyramid Laboratories Facility Tour
PYRAMID Laboratories, Inc. is a CDMO, focused on parenteral drug products, that offers comprehensive pipeline of services to pharmaceutical and biotech companies. read more »

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» Featured Whitepaper
eBook: Pharmaceutical Synthesis & Specialty Ingredients
This eBook takes a detailed look at the issues that affect the pharmaceutical manufacturing industry. read more »
Meet Hound: Three Lasers Make Particle ID a Breeze
Hound combines automated microscopy, dual Raman at 532 nm and 785 nm, and Laser Induced Breakdown Spectroscopy (LIBS) in a single instrument to ... read more »
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| Events
EVENT
  Driving Data Integrity in the Right Direction
Online –  04/07/2020
During this webinar, we investigated trends seen globally for data integrity violations and avenues for remediation. event details »
EVENT
  Pre-Filled Syringes East Coast 2020
Virtual –  10/26/2020
The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion... event details »
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