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ALLE LÄNDER (14)
1
Implementation of Single-Use Technology in Biopharmaceutical Production
18. Jan 2024 - 21. Mär 2024 • San Diego, Vereinigte Staaten
Veranstalter:
CHI
Zusammenfassung:
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.
Kontakt:
Email: chi@healthtech.com
Eintrags-ID:
1594342
2
FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
14. Mär 2024 - 15. Mär 2024 • Washington DC, Vereinigte Staaten
Veranstalter:
FDAMap
Zusammenfassung:
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.
Themen:
Gmp, Phase 1, Clinical Trials, Clinical Research, Clinical Studies, Clinical Operations, Clinical Development, FDA Complience, FDA Regulation,
Eintrags-ID:
1601132
3
Pharma Regulatory Summit 2024
21. Mär 2024 • Mumbai, Indien
Veranstalter:
Virtue Insight
Zusammenfassung:
The 7th Annual Pharma Regulatory Summit 2024 congregates foremost global pharmaceutical industry professionals and regulators to share their insights on technologies, approaches, and solutions that will drive innovation and quality for the medicines delivered to patients worldwide. This interactional setting with expert-led regulatory and industry presentations, and forums will ensure pharmaceutical industry professionals are expedient to develop and apply ingenious solutions in today’s global regulatory environment.
Kontakt:
Tel.: [9361957193];     Email: Kavitha@virtueinsight.co.in
Themen:
7th Annual Pharma Regulatory 2024 21st March 2024, Hotel Kohinoor Continental Hotel, Mumbai, India The 7th Annual Pharma Regulatory Summit 2024 congregates foremost global pharmaceutical industry professionals and regulators to share their insights on technologies, approaches, and solutions that will drive innovation and quality for the medicines delivered to patients worldwide. This interactional setting with expert-led regulatory and industry presentations, and forums will ensure pharmaceutical industry professionals are expedient to develop and apply ingenious solutions in today’s global regulatory environment.
Eintrags-ID:
1600286
4
Precision Med TRI-CON 2024 — Precision Med TRI-CON 2024
26. Mär 2024 - 28. Mär 2024 • San Diego, Vereinigte Staaten
Veranstalter:
CHI
Zusammenfassung:
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!
Eintrags-ID:
1606916
5
3rd Pharma Summit: Drug Discovery & Community Trial
27. Mär 2024 - 28. Mär 2024 • SANUR, Bali, Indonesien
Veranstalter:
Association Of Pharmaceutical Research
Zusammenfassung:
This conference aims to bring together leading academic scientists, researchers and scholars to exchange and share their works and research results on all aspects of Pharmacology, Pharmaceutical Biotechnology, Pharmacogenomics, Drug Delivery, Bio-drugs, Pharmacovigilance and Drug Safety, Pharmaceutical Microbiology, Pharmaceutical Research and Development, Pharmaceutical Analysis and Quality Curatives, Bio-therapeutics, Radiopharmaceuticals, Vaccine Design, Formulation Technologies, Clinical Pharmacy, Industrial Pharmacy, Pharmaceutical Chemistry and Pharmaceutics.
Kontakt:
Tel.: [+91 9884076645];     Email: pharmasummit@apr.in.net
Eintrags-ID:
1597877
Verwandte Fachgebiete:
6
Technical and Regulatory Writing for FDA-Regulated Industry
04. Apr 2024 - 05. Apr 2024 • Washington DC, Vereinigte Staaten
Veranstalter:
FDAMap
Zusammenfassung:
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.
Themen:
Technical Writing, Regulatory Writing, Clinical Trials, Clinical Research, Clinical Development, Clinical Studies, Electronic Submission, FDA Regulations, FDA Compliance
Eintrags-ID:
1601208
7
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:
1601748
8
GCC Regulatory Affairs Pharma Summit 2024
22. Apr 2024 - 26. Apr 2024 • Dubai, Vereinigte Arabische Emirate
Veranstalter:
Hubplus Events
Zusammenfassung:
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.
Kontakt:
Marketing manager;     Email: rabie
Eintrags-ID:
1593507
Verwandte Fachgebiete:
9
PEGS Boston Summit 2024 — Essential Industry Conference for Streamlining Biologics Development
13. Mai 2024 - 17. Mai 2024 • Boston, Vereinigte Staaten
Veranstalter:
CHI
Zusammenfassung:
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.
Kontakt:
Email: chi@healthtech.com
Eintrags-ID:
1607976
10
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:
1601714
11
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:
1601746
12
NIK 2024 — 8. Nationale Impfkonferenz
13. Jun 2024 - 14. Jun 2024 • Rostock Warnemünde, Deutschland
Eintrags-ID:
1601915
13
Laserschutzkurs nach OStrV und TROS für die Medizin und Ästhetik
27. Sep 2024 • Berlin, Deutschland
Zusammenfassung:
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.
Eintrags-ID:
1602513
Verwandte Fachgebiete:
14
Online-Refresher-Laserschutzkurs nach OStrV und TROS für die Medizin und Ästhetik
15. Nov 2024 • Berlin, Deutschland
Zusammenfassung:
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.
Eintrags-ID:
1602465
Verwandte Fachgebiete:


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Stand vom 15. Februar 2024