Conférences  >  Médecine & Soins de Santé  >  Pharmacologie et développement des médicaments  >  États-Unis

ComplianceOnline

This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn statistical methods related to ICH guidelines and will discover how regulatory agencies, such as the FDA expect organizations to meet these guidelines.

ICH Quality Guidelines seminar, Statistical Considerations seminar, ICH guidelines, pharmaceutical manufacture, biotech manufacture, statistical methods, ICH guidelines compliance, statistical methods tools, statistical methods templates, regression analysis, confidence intervals, tolerance intervals, appropriate sample size, risk probability, process characterization for design space, FDA regulatory requirements

Biotechnologie,    Pharmacogénétique, Médecine personnalisée

CHI

Join a vibrant community of scientists, trailblazers, and industry leaders at PepTalk 2026, as we mark 25 years of accelerating breakthroughs in biotherapeutic discovery and development. Renowned as one of the most influential events in protein science, PepTalk is where fresh ideas ignite, collaborations flourish, and next-generation solutions take shape.

This year’s expanded agenda features symposia and conference tracks, covering protein expression, production platforms, lab automation for higher throughput, analytical characterization and preformulation strategies for novel modalities, antibody discovery and development, and new this year - expression and development of therapeutic peptides and miniproteins.

Tél.: [781.972.5400];     Email.: chi@healthtech.com

FDAMap

Are you ready to elevate your clinical trial process with the power of smart trials? This one-day virtual program is your gateway to transforming how trials are conducted. Imagine cutting timelines, slashing costs, and driving incredible ROI with advanced virtual tools, data-driven methodologies, and streamlined operations! This program will take you from traditional trial challenges to a smart, virtual-first strategy that amplifies results and redefines success.

FDA, Smart Clinical Trials, Clinical Trials, FDA Regulation, FDA Compliance

Législation en médecine et pharmacologie,    Médecine translationnelle, essais cliniques

FDAMap

Clinical trials are highly regulated multi-dimensional projects that require constant interactions between the regulators and the sponsors, investigators, other personnel, and even patients involved in the conduct of a given trial. There are many diverse tasks involved in the conduct of a clinical trial starting from the development of a clinical trial protocol, finding and starting clinical trial sites, filing of an IND or IDE application, approvals from IRBs, numerous documents need to be collected to demonstrate compliance with regulations; managing supplies, collecting data, writing reports, and many other things. Clinical project managers need to understand, implement, and trouble-shoot practically all aspects of the clinical trial under them. Clinical project managers have to build teams and have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. This one-of-a-kind program will train you in regulatory affairs, clinical operations, monitoring, patient recruitment and retention, planning, medical writing, safety monitoring and practically all major aspects of running a clinical trial.

FDA, Clinical Project Management, FDA Regulation, FDA Compliance

Législation en médecine et pharmacologie,    Médecine translationnelle, essais cliniques

FDAMap

Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. Most of the refuse-to-accept deficiencies are due to the inexperience of the 510k writers, who ignore the FDA rules. Writing and assembling a complete and well structured 510(k) submission will certainly improve the likelihood of FDA clearance on the first round.

FDA, 510(k) Submissions, FDA Regulation, FDA Compliance

FDAMap

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

FDA, SOPs, FDA Regulation, FDA Compliance

Législation en médecine et pharmacologie,    Médecine translationnelle, essais cliniques

FDAMap

In the field of regulatory affairs, professionals often encounter the task of writing complex documents for diverse audiences. These documents encompass a wide range, including reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and various communication documents. The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others.

FDA, ​Technical Writing, Regulatory Writing, FDA Regulation, FDA Compliance

Législation en médecine et pharmacologie,    Médecine translationnelle, essais cliniques

American Society for Experimental Neurotherapeutics (ASENT)

ASENT's 2026 Annual Meeting is the premier neuroscience and neurotherapeutics conference where leaders from providers and prescribers, employers, investors, fast-growing startups, big pharma, policymakers, funders & innovation centers gather to improve the process of bringing neurotherapeutics to market.

Tél.: [8332731556];     Email.: jessica@asent.org

Neurology, Neurotherapeutics, Neuroscience, Biotech, Bioengineering, FDA, NIH, Drug Development, Pipeline Presentations