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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.

Tel.: [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

Legislation in der Medizin und Pharmakologie,    Translationale Medizin, Klinische Studien

ComplianceOnline

Seminar participants will learn the following: Gain an understanding of the fundamental principles and skills necessary to conduct Aseptic Processing of Sterile Drug Products with minimum risk, Analyze issues impacting Aseptic Processing to include the environment, personnel, gowning and sanitization, Acquire the skills necessary to control the process environment, Minimize media fill failures to permit production throughput, Determine how to develop media fill simulations to include the "worst case" scenarios, Learn best practice techniques for determining media fill sizes, Understand the "critical factors" required to maintain compliance, Decrease inspectional observations, Avoid Warning Letters and Consent Decrees

aseptic processing, environmental monitoring, gmp, sterile drug products, fda guidance for sterile products, sterile filtration during accepting processing, aseptic sterile manufacturing, aseptic process validation, aseptic fda guidance

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

Legislation in der Medizin und Pharmakologie,    Translationale Medizin, Klinische Studien

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

Legislation in der Medizin und Pharmakologie,    Translationale Medizin, Klinische Studien

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

Legislation in der Medizin und Pharmakologie,    Translationale Medizin, Klinische Studien

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.

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

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

BOC Sciences

March 23rd, 2026 10:00 EDT

This webinar, featuring Prof. Nikolai Petrovsky, explores how recent research and tools like artificial intelligence are unlocking the broad pharmaceutical utility of polysaccharides, using inulin as a key case study.

Event Administrator;     Email: account@bocsci.com

Chemistry and properties of polysaccharides; Research tools for polysaccharides; Solving polysaccharide structures using AI; Pharmaceutical utility of polysaccharides;