The 2nd Annual Bioequivalence Summit, taking place October 5-6, 2015, is the premier event for those in development, research, clinical and academia to convene and exchange ideas on how best to maximize drug delivery.
Since the passage of the ACA, the availability of generic, affordable drugs has been brought to the forefront of the FDA’s agenda. In turn, developers are using advanced testing methods, exploring alternate delivery methods and expanding into biosimilars to better serve the expanding consumer base. But while discovery is forging ahead, regulatory ambiguity continues to be a hurdle. Approval delays and unclear testing requirements are proving to be challenges going forward.
Both the innovation and the challenges in this area will be presented at the 2nd Annual Bioequivalence Summit, where leaders from all aspects of drug development will give in-depth presentations covering the current landscape. Click on the buttons below for more information.
Join us at the largest meeting in Europe dedicated to Trial Master File. Now in its fourth year, ExL Pharma’s European Trial Master File Summit will take place 12 – 13 October in London, UK. This summit will feature the industry’s top TMF experts discussing best practices for developing, managing and monitoring a TMF process that complies with regulations and passes audits and inspections.
We are excited to announce that Andy Fisher, Senior GCP Inspector for the MHRA, will be delivering our keynote presentation. This event will also feature sessions covering everything you need to know about Version 3.0 of the TMF Reference Model, which was just recently released. This is an exciting time for the industry and we hope you will join us in London this October!
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Join us October 29-30, 2015 in Philadelphia, PA for our ePatient Connections 2015 summit. This event focuses on bridging the communication gap between industry leaders and ePatients to establish shared goals in order to enable cross-functional, patient-centric collaboration to improve overall health outcomes and enhance participation in clinical trials. All stakeholders benefit from the consolidation of industry knowledge, patient experience and insights.
Additionally, through multiple case studies and panel sessions, this event offers actionable strategies for industry leaders to communicate and connect with ePatients and ePatient communities in an evolving regulatory landscape.
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Join us November 2-3 in Bethesda, MD for our inaugural CNS Clinical Trials Forum to discover how to best position your clinical trial for success via unique partnering and licensing agreements, ideal patient recruitment strategies, accurate predictive outcome models, and more.
Pharmaceutical companies developing new CNS products face complex obstacles in improving trial processes and quality in order to optimize products’ life cycles — not only are CNS trials more expensive and more time consuming than other trials, they’re also less likely to be successful and gain approval. With therapies for CNS-related disorders representing 21% of the total pharmaceutical marketplace but only 8% of CNS drugs making it through clinical trials, it’s clear that a well-executed CNS clinical trial can be extremely lucrative for a company.
Regulators, physicians and patients are showing unprecedented interest in the addiction risks of prescription drugs, and new regulatory guidelines for generic opioids are expected before the end of the year. The 2nd Human Abuse Liability & Abuse-Deterrent Formulations conference, taking place November 2-3 in Bethesda, MD, is the largest and most in-depth event devoted to minimizing drug abuse potential. More than 20 speakers in two program tracks will arm your teams with the latest strategies to avoid regulatory penalties and succeed at both clinical and preclinical analysis of abuse liability. Attend to hear experts in the fields of toxicology, safety pharmacology, regulatory affairs, epidemiology, biostatistics and risk mitigation describe their techniques for minimizing prescription opioid abuse throughout the full drug design and marketing cycle.
Kelly Willenberg LLC is a full service research compliance organization serving clients on improving operations. She employs technologies to improve operational aspects of compliance based on client needs. She assists in the implementation of billing compliance programs, offers training seminars, builds coverage analysis and helps with process improvement. She can also assist with process improvement, quality assurance and assessing vulnerabilities in all aspects of research compliance.
Abuse-Deterrent Formulations Save Lives
As we near the end of 2015, it is obvious that the prescription drug crisis identified by the White House in 2011 has gotten even more desperate and requires urgent action. An estimated 16,000 lives are lost each year due to prescription opioid abuse. That’s 46 mothers, fathers, sisters and brothers lost every single day of the year.
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