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1
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:
1601680
2
Clinical Trials Summit 2024
29 mai 2024 - 30 mai 2024 • Mumbai, Inde
Organisateur:
Virtue Insight
Résumé:
15th Annual Clinical Trials Summit 2024 will provide a platform to discuss on the futuristic advancements in Clinical Trials and clinical research. This multidisciplinary program involves broad participation of people from Clinical Trials community who are focused on learning more about clinical research, Clinical Trials planning & management. This event opens discussion of timely topics of mutual theoretical and practical interest for clinical trial investigators who are developing new drugs and biologics. This groundbreaking platform continues the conversation between business, academics, patient advocacy, and regulatory agencies to discuss new methods and solutions to statistical challenges relevant to the design and analysis of Clinical Trials collaboratively in the real world. It is high time that we look into innovative strategies, new technologies, effective and quality collaborations to address these issues, which can cater to the needs of the patient and the industry.
Contact:
Email.: Kavitha@virtueinsight.co.in
Sujets:
clinical trials, clinical research, CROs, Clinical studies, drugs, regulatory, patients, clinical R&D, Medical Affairs, Regulatory Affairs, Quality control, pharma, pharmaceuticals
Identifiant de l'évènement:
1609508
3
510(k) Submissions — 510(k) Submissions to the FDA: Hands-On Workshop
30 mai 2024 - 31 mai 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.

This hands-on workshop is done by one of the industry’s top regulatory expert. The trainer has performed numerous reviews of 510(k) submissions over the last 15 years, and has analyzed the reasons that most often lead to delays in getting submissions ultimately cleared by FDA. This hands-on workshop will walk the attendees through the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.

Sujets:
FDA, 510 K Submission, 510 K Writers, FDA Compliance, FDA Regulations,
Identifiant de l'évènement:
1616027
4
ESMO GI 2024 — ESMO Congress on Gastrointestinal Cancers 2024
26 jui 2024 - 29 jui 2024 • Munich, Allemagne
Organisateur:
European Society for Medical Oncology (ESMO)
Résumé:
Brought to you by the European Society for Medical Oncology (ESMO), the congress will be the place to present very impactful new data in GI oncology. The scientific sessions will be complemented with high quality educational sessions and excellent networking opportunities.

In recent years we have seen remarkable progress in the treatment options available for patients with GI cancers and ESMO is committed to ensuring that there is a clear roadmap to help facilitate the implementation of new practice changing discoveries in the clinic for the benefit of all patients with GI cancers and whose wellbeing is our primary concern. The ESMO Gastrointestinal Cancers Congress will provide global visibility for original clinical and translational research.

Contact:
Tél.: [+41 (0)91 973 19 62];     Email.: gicongress@esmo.org
Sujets:
Esophageal Cancer, Gastric Cancer, Hepatocellular Cancer, Pancreatic Cancer, Biliary Tract Cancer, Neuroendocrine Tumors, Colon Cancer, Rectal Cancer, GIST, Anal Cancer, Gastrointestinal Cancers
Identifiant de l'évènement:
1569510
Sujets apparentés:
5
IWBBIO — International Work-Conference on Bioinformatics and Biomedical Engineering
15 jul 2024 - 17 jul 2024 • Las Palmas de Gran Canaria, Espagne
Organisateur:
University of Granada
Résumé:
The IWBBIO 2024 (11th International Work-Conference on Bioinformatics and Biomedical Engineering) seeks to continue the good synergy obtained in the previous edition, providing a discussion forum for scientists, engineers, educators and students about the latest ideas and realizations in the foundations, theory, models and applications for interdisciplinary and multidisciplinary research encompassing disciplines of computer science, mathematics, statistics, biology, bioinformatics, and biomedicine. The aims of IWBBIO 2024 is to create a friendly environment that could lead to the establishment or strengthening of scientific collaborations and exchanges among attendees, and therefore, IWBBIO 2024 solicits high-quality original research papers (including significant work-in-progress) on any aspect of Bioinformatics, Biomedicine and Biomedical Engineering.
Contact:
Email.: iwbbio@ugr.es
Sujets:
bioinformatics, bioimaging devices, biomedical, biomedical signal processing, biomedical computing, artificial intelligence, biotechnology,
Identifiant de l'évènement:
1596937
6
Medical Device Days — Medical Device Days - Die Speed-Consulting-Konferenz für Medizinproduktehersteller
08 oct 2024 - 09 oct 2024 • Berlin, Allemagne
Organisateur:
Johner Institut GmbH
Résumé:
Die Medical Device Days sind eine Speed-Consulting Konferenz für Medizinproduktehersteller, auf welcher sich die Teilnehmenden in kürzester Zeit zu sämtlichen regulatorischen Themen beraten lassen und weiterbilden können. Dabei stehen die Beantwortung der individuellen Fragen sowie der Austausch mit anderen Teilnehmenden und unserem Team im Vordergrund.
Contact:
Email.: events@johner-institut.de
Sujets:
MDR, IVDR, Biokompatibilität, Risikomanagement, Künstliche Intelligenz, UDI, EUDAMED, Usability Engineering, QM, IT-Security, klinische Studien, klinische Bewertung, Regulatory Affairs, DiGA, Zulassung
Identifiant de l'évènement:
1603862
Sujets apparentés:
7
ESMO Asia 2024 — ESMO Asia Congress 2024
06 dec 2024 - 08 dec 2024 • Singapore, Singapour
Organisateur:
ESMO - European Society for Medical Oncology
Résumé:
ESMO Asia is an annual congress specifically focused on multidisciplinary oncology in the Asian region. ESMO Asia 2024 will feature scientific sessions covering a wide range of topics related to oncology, including advances in cancer research, new treatment modalities, and discussions on the management of specific types of cancer. Its educational sessions will provide in-depth training and insights into specific aspects of oncology, ensuring that participants gain practical knowledge that they can apply in their daily practice.
Contact:
ESMO Asia 2024 Secretariat;     Email.: asiacongress@esmo.org
Sujets:
oncology, translational research, clinical trials, breast cancer, CNS, precision medicine, gastrointestinal tumours, genitourinary tumours, gynecological tumours, haemathological malignancies, head and neck cancers, immunotherapy, melanoma, sarcoma, rare tumours, thoracic cancer, supportive care, palliative care, Clinical Practice Guidelines, radiology
Identifiant de l'évènement:
1616495


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Dernière mise à jour: 24 avril 2024