INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Strategic Regulatory Documentation Practice

  Delve into how inSeption Group’s highly experienced Global Regulatory Documentation Group integrates with organizations to seamlessly manage the complexities of timeline creation and management, resourcing, document interdependencies, and transmission to health authorities.

• Inside The ISCT Global Regulators Summit 2023

  The ISCT Global Regulators Summit occurred on May 30, 2023. Immediately following the Summit, I attended a post-event press conference to learn the key highlights of the proceedings. Here's what I learned.

• Improve Your Quantification and Contamination Detection With ddPCR™ Technology

  Explore solutions to help labs with quantification and biotherapeutic contaminant detection. These tools include including software that supports regulatory compliance with U.S. FDA 21 CFR Part 11 regulations.

• From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation

  Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.

• Meeting pDNA Demand With Project Management And Integrated Teams

  Examine how project management and integrated, cross-functional project teams are key qualities to look for in a CDMO to ensure continuous alignment of goals towards the delivery of pDNA.

• All You Need To Know About Contamination Control Strategies, Part 2

  In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.

• FDA’s Digital Health Technologies Framework Addresses Important Challenges

  In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.

• Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials

  The establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.

• All You Need To Know About Contamination Control Strategies, Part 1

  In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.

• Discussing The Importance Of Data Integrity

  Watch as the Project Farma team shares why implementing data integrity early is crucial to promising results in advanced medicines.