Challenges and Successes of ICH Q12 Related Submissions

Pharmaceutical manufacturers often have the task of reducing waste to meet company expectations, document the process to meet regulatory requirements and improve quality to meet customer specifications. Let's be honest, not achieving any of the above points is not an option in most pharmaceutical companies. That's where the capacity analysis comes into play.

The field of immuno-oncology has exploded in the clinic, in the press, and on Wall Street, particularly regarding the use of genetically modified immune cells to fight cancer. This “explosion” is largely due to the success of chimeric antigen receptor (CAR) T-cell therapy. The fields of immunology and gene therapy have converged to harness recombinant viruses to deliver “living drugs” with remarkable clinical efficacy, especially for patients with blood cancers. Multiple approaches to engineering immune cells mostly T cells but also other immune cell types make use of CARs, while tumor-specific T-cell receptors continue to gain a foothold in the field, mostly for the treatment of solid tumors. Several genome-editing approaches are now available, including established technologies such as zinc-finger nucleases, and newer modalities like the CRISPR/Cas9 system. These methodologies have recently been applied to augment the antitumor efficacy of adoptively transferred cells in the clinic by knocking out negative regulatory molecules such as PD1.

In this webinar, the validation of an interactive response technology (IRT) solution built with configurable parameters will be explored. Traditionally, interactive response technology solutions require validation of each study-specific requirement to ensure proper implementation. With the prevalence of configurable interactive response technology solutions where the validation of each configurable parameter occurs within the product, the need for full validation of each requirement within a clinical study has lessened. This webinar will explore how to take advantage of configurations and how to verify them, thereby reducing the effort and timeline required for validation while still maintaining quality within each study.

Medical malpractice cases are expensive and becoming harder to defend so it is more imperative than ever to be proactive and avoid them. What specifically can health systems do to limit potential exposure? Learn these answers from a nationally recognized and seasoned defense attorney. The information will provide guidance for health care providers and risk professionals on how to limit their exposure from the time of the negative event at issue through trial. Additionally, the information will include common issues pertaining to the EMR with special emphasis on managing the discovery of the audit trail. Gain a firm understanding of how a patient's lawyer prosecutes a claim and ways to avoid making a medically defensible case hard to win. With medical malpractice cases becoming more sophisticated, no one can afford to ignore the issues and legal processes. Don't be left behind - review this information and stay ahead of the curve. It could be the difference between winning or losing a case.