Conférences  >  Médecine & Soins de Santé  >  Législation en médecine et pharmacologie

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1
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:
1601131
2
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:
1601693
3
GCC Regulatory Affairs Pharma Summit 2024
22 avr 2024 - 26 avr 2024 • Dubai, Émirats arabes unis
Organisateur:
Hubplus Events
Résumé:
GCC Regulatory Affairs Pharma Summit is an annual event that provides platform for pharmaceutical regulatory experts and industry professionals in the GCC region to share insights and discuss about the latest updates in the pharmaceutical regulations. This Summit is one of the first and strategic meeting place in the GCC region for local and international pharmaceutical and medical industry professionals to meet and discuss on topics related to all aspects of regulatory affairs, legal and compliance.
Contact:
Marketing manager;     Email.: rabie
Identifiant de l'évènement:
1593529
4
Pharmacovigilance USA 2024
02 mai 2024 - 03 mai 2024 • Boston, États-Unis
Organisateur:
Virtue Insight
Résumé:
After the successful journey of a series of 34 Pharmacovigilance conferences, Virtue Insight is proud to announce its 35th Pharmacovigilance 2024. We have been delivering the conference through close collaboration with the industry leaders for more than a decade. For the 2024 edition, the agenda includes a host of new and exciting features. Take a chance and make it count by attending this conference to network with your peers, exchange expertise and experiences, and arm yourself with the latest information to take your department to the next level.
Contact:
Email.: Kavitha@virtueinsight.co.in
Sujets:
Pharmacovigilance, regulatory affairs, Drug Safety, Drug Development, patient safety, RiskManagement, Pharmaceuticals, healthcare
Identifiant de l'évènement:
1609487
5
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:
1607987
6
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:
1601714
7
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:
1601779
8
NIK 2024 — 8. Nationale Impfkonferenz
13 jui 2024 - 14 jui 2024 • Rostock Warnemünde, Allemagne
Identifiant de l'évènement:
1601882
9
Laserschutzkurs nach OStrV und TROS für die Medizin und Ästhetik
27 sep 2024 • Berlin, Allemagne
Résumé:
Erst-und Nachschulung als Laserschutzbeauftragter für medizinische und kosmetische Anwendungen (Präsenzkurs) Der 1-tägige Laserschutzkurs zum Laserschutzbeauftragten für die Medizin und Ästhetik vermittelt die für den Umgang mit medizinischen Lasern der Klassen 3R, 3B und 4 notwendigen arbeitsschutz-und unfallschutzrechtlichen Fachkenntnisse. Mit dem erfolgreichen Kursabschluss wird gegenüber Behörden die gesetzlich geforderte Qualifikationals Laserschutzbeauftragter für medizinische und kosmetische Anwendungen nachgewiesen.
Identifiant de l'évènement:
1602524
Sujets apparentés:
10
Online-Refresher-Laserschutzkurs nach OStrV und TROS für die Medizin und Ästhetik
15 nov 2024 • Berlin, Allemagne
Résumé:
Der 1-tägige Refresher-Laserschutzkurs für die Medizin und Ästhetik frischt die für den Umgang mit medizinischenoder kosmetischen Lasern der Klassen 3R, 3B und 4 notwendigen arbeitsschutz-und unfallschutzrechtlichen Fachkenntnisse auf. Mit dem erfolgreichen Kursabschluss wird gegenüber Behörden der Nachweis über die alle 5 Jahre geforderte Fortbildung als Laserschutzbeauftragter erbracht.
Identifiant de l'évènement:
1602432
Sujets apparentés:


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Dernière mise à jour: 1 mars 2024