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1
Implementation of Single-Use Technology in Biopharmaceutical Production
18 jan 2024 - 21 mar 2024 • San Diego, États-Unis
Organisateur:
CHI
Résumé:
This interactive 30-hour course provides an introduction to single-use systems (SUS) in the biopharmaceutical industry, covering methods, requirements, and emerging trends in licensed biopharmaceutical therapeutics. Participants will gain a solid understanding of current good manufacturing practice (cGMP) guidelines, SUS application, and different types of SUS. The course will explore the fundamentals of biopharmaceutical production and provide attendees with the knowledge necessary to produce human therapeutics.
Contact:
Email.: chi@healthtech.com
Identifiant de l'évènement:
1594342
2
FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
14 mar 2024 - 15 mar 2024 • Washington DC, États-Unis
Organisateur:
FDAMap
Résumé:
Manufacturing an investigational product for the initial pilot clinical trials can be a complex and costly endeavor for developers. These first-in-man and pilot clinical trials, usually conducted with a small number of healthy participants, are primarily aimed at establishing safety. Therefore, they do not require a significant amount of investigational material. Recognizing this, the US FDA allows developers to test early-stage investigational products under relaxed GMP requirements. During our comprehensive workshop, we will delve into the current regulations, guidance documents, and regulatory strategies that are available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. This training will equip you with valuable insights on how to ensure the quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing.
Sujets:
Gmp, Phase 1, Clinical Trials, Clinical Research, Clinical Studies, Clinical Operations, Clinical Development, FDA Complience, FDA Regulation,
Identifiant de l'évènement:
1601121
3
Precision Med TRI-CON 2024 — Precision Med TRI-CON 2024
26 mar 2024 - 28 mar 2024 • San Diego, États-Unis
Organisateur:
CHI
Résumé:
For 3 decades, the Precision Med TRI-CON has served as the leading international meeting place for the diagnostics and precision medicine community. Join thousands of international thought leaders to discuss the latest research, technologies, innovation and business models in implementing precision medicine, biomarkers and companion diagnostics, genomic medicine, and precision health; innovation and market access strategies for at-home diagnostics, point-of-care testing and molecular diagnostics for infectious diseases; liquid biopsy and advanced diagnostics for precision oncology, including Multi-Cancer Early Detection and Minimal Residual Disease testing. Emerging implications of faster and cheaper sequencing, AI and digital tools, rare disease diagnostics and gene therapies, and spatial biology and single-cell multiomics in advancing precision medicine will be covered in 2024. Join us in sunny San Diego for the in-person networking and visionary and thought-provoking keynote discussions you’ve come to expect from the TRI-CON!
Identifiant de l'évènement:
1606872
4
Technical and Regulatory Writing for FDA-Regulated Industry
04 avr 2024 - 05 avr 2024 • Washington DC, États-Unis
Organisateur:
FDAMap
Résumé:
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. During the workshop, the trainer Dr. Mukesh Kumar will share practical tips and utilize examples to demonstrate effective methods of organizing and conveying information in clear and readable documents. They will cover essential aspects such as editing, formatting, presenting, and publishing technical regulatory documents to ensure they are well-received by regulatory agencies. Additionally, the workshop will explore the guidelines for writing documents intended for electronic submission to FDA and other regulatory authorities. This unique workshop is designed to equip regulatory writers of all skill levels with technical, practical, logical, and logistical tips to enhance their abilities.
Sujets:
Technical Writing, Regulatory Writing, Clinical Trials, Clinical Research, Clinical Development, Clinical Studies, Electronic Submission, FDA Regulations, FDA Compliance
Identifiant de l'évènement:
1601197
5
510(k) Submissions — 510(k) Submissions to the FDA: Hands-On Workshop
18 avr 2024 - 19 avr 2024 • washington dc, États-Unis
Organisateur:
FDAMap
Résumé:
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.
Sujets:
510 K, 510 K Submission, FDA Regulation, FDA Complience
Identifiant de l'évènement:
1601660
6
PEGS Boston Summit 2024 — Essential Industry Conference for Streamlining Biologics Development
13 mai 2024 - 17 mai 2024 • Boston, États-Unis
Organisateur:
CHI
Résumé:
The PEGS Boston Summit brings together leading experts at the forefront of biologics innovation, providing insights into the latest technologies, research, and advancements in drug development, protein and antibody engineering, immunotherapy, immunogenicity, expression platforms, multispecific antibodies, machine learning and AI in biologics, and more. PEGS Boston features main conference sessions as well as deep dive training seminars and topic-focused short courses. PEGS Boston Summit is your number one resource for protein engineering updates and is the conference to attend in 2024 to network, collaborate, and learn from the industry's best.
Contact:
Email.: chi@healthtech.com
Identifiant de l'évènement:
1607965
7
eCTD Submissions of IND and NDA/BLA — eCTD Submissions of IND and NDA/BLA to the US FDA: Hands-on Workshop
15 mai 2024 • washington dc, États-Unis
Organisateur:
FDAMap
Résumé:
FDA now requires all DMFs be submitted only in the electronic CTD format which creates a huge burden on owners of most submissions. Converting to eCTD format requires special skills, software and resources, the cost of which could be prohibitive to small manufacturers. Our speaker, Dr. Mukesh Kumar, in this workshop will go over the details of the latest guidance on eCTD submission and explain the key takeaways.
Sujets:
E CTD, E CTD Submissions, FDA Compliance, FDA Regulation
Identifiant de l'évènement:
1601758
8
FDA Compliant SOPs for Regulated Industry — FDA Compliant SOPs for Regulated Industry: How to Create High Quality SOPs that Your Team and FDA Auditors Will Love
23 mai 2024 - 24 mai 2024 • washington dc, États-Unis
Organisateur:
FDAMap
Résumé:
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.
Sujets:
FDA, SOPs, Quality Management System, Clinical Trials, Clinical Studies, Clinical Research, Clinical Development, FDA Regulation, FDA Complience
Identifiant de l'évènement:
1601691


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Dernière mise à jour: 15 février 2024