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1
510(k) Submissions — 510(k) Submissions to the FDA: Hands-On Workshop
18. Apr 2024 - 19. Apr 2024 • washington dc, Vereinigte Staaten
Veranstalter:
FDAMap
Zusammenfassung:
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.
Themen:
510 K, 510 K Submission, FDA Regulation, FDA Complience
Eintrags-ID:
1601693
2
Pharmacovigilance USA 2024
02. Mai 2024 - 03. Mai 2024 • Boston, Vereinigte Staaten
Veranstalter:
Virtue Insight
Zusammenfassung:
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.
Kontakt:
Email: Kavitha@virtueinsight.co.in
Themen:
Pharmacovigilance, regulatory affairs, Drug Safety, Drug Development, patient safety, RiskManagement, Pharmaceuticals, healthcare
Eintrags-ID:
1609509
3
Pharma Partnering US Summit 2024
14. Mai 2024 - 15. Mai 2024 • San Diego, Vereinigte Staaten
Veranstalter:
Pharma Partnering Summit
Zusammenfassung:
The Pharma Partnering Summit is an exclusive Life Sciences Industry event, with the aim to help companies expand their network and put together licensing deals, research collaborations and financing. Our platform brings together senior executives from different parts of the world specializing in Business Development & Licensing, Alliance Management, Research Collaborations, M&A and Investment. In addition to identifying products and partners as well as investors, the forum also serves to disseminate knowledge through expert speakers, for the best practices in the field of industry partnerships.
Kontakt:
Tel.: [The Pharma Partnering Summit is an exclusive Life Sciences Industry event, with the aim to help companies expand their network and put together licensing deals, research collaborations and financing. Our platform brings together senior executives from di;     Email: taiba@pharma-partneirng-summit.co.uk
Themen:
Business Development, Licensing, Alliances, Collaboration, Partnership, External Innovation, Search and evaluation, M&A, Pharma biotech Year.
Eintrags-ID:
1603958
4
Digital Health Envision Summit 2024
14. Mai 2024 - 15. Mai 2024 • San Diego, Vereinigte Staaten
Veranstalter:
Pharma Partnering Summit
Zusammenfassung:
Welcome to the Digital Health Envision Summit, where the future of healthcare comes to life! Join us as we bring together Dealmakers, Innovators, Investors, and Decision-makers from the Pharma & Biotech sector to explore the transformative potential of Digital Health therapies and technologies. This Summit is the ultimate platform for discovering new products, unlocking business opportunities, fostering collaboration, and igniting innovation in the industry.

Immerse yourself in a dynamic environment where Big, Midsize, and Small Pharma & Biotech companies come together to showcase their cutting-edge assets, revolutionary products, ground-breaking technologies, innovative platforms, and game-changing services. Connect with potential Partners and visionary minds who share your passion for driving innovation and shaping the future of healthcare.

Kontakt:
Tel.: [441753253192];     Email: taiba@pharma-partneirng-summit.co.uk
Themen:
Digital Health, Business development, Partnership, Innovation, Real world, Digital neurology, Digital therapeutics, Drug discovery, Regulatory affairs, Artificial Intelligence, Machines learning, Data analytics, Decision Health, BAB, Oral health
Eintrags-ID:
1603946
5
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, Vereinigte Staaten
Veranstalter:
FDAMap
Zusammenfassung:
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.
Themen:
E CTD, E CTD Submissions, FDA Compliance, FDA Regulation
Eintrags-ID:
1601670
6
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, Vereinigte Staaten
Veranstalter:
FDAMap
Zusammenfassung:
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.
Themen:
FDA, SOPs, Quality Management System, Clinical Trials, Clinical Studies, Clinical Research, Clinical Development, FDA Regulation, FDA Complience
Eintrags-ID:
1601779
7
ipharma@2024 — International Pharmaceutical Business Expo 2024
16. Aug 2024 - 17. Aug 2024 • Boston, Vereinigte Staaten
Veranstalter:
i Pharma Expo
Zusammenfassung:
iPharma Expo 2024, USA (International Pharmaceutical Business Expo 2024) scheduled during August 16- 17, 2024 , at Boston, USA.
Kontakt:
Tel.: [(617) 275-2612];     Email: kathy@ipharmaexpo.net
Themen:
Pharma Expo, pharma congress, pharma Expo USA, pharmaceutical event, pharma USA, pharmaceutical expo, international pharma, iPharma USA
Eintrags-ID:
1613212


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