Conférences - Législation en médecine et pharmacologie

Sélecionner un pays:
Canada (1) - Inde (2) - Singapour (1) - États-Unis (6)

TOUS LES PAYS

1
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings
28 mar 2019 - 29 mar 2019 • Philadelphia, PA, États-Unis
Résumé:
In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.
Contact:
Tél.: [8887172436];     Email.: referral@complianceonline.com
Sujets:
"conducting FDA meetings, investigational new drug (IND), investigational device exemptions (IDE) applications, investigational device exemptions (IDE) applications, guidance documents for drug and device submissions, IND and IDE application process, IND maintenance, orphan drug designation, IDE maintenance, humanitarian device exemption (HUD), investigational new drug application preparation"
Identifiant de l'évènement:
1182885
2
Pharmaceutical Quality Management System
02 avr 2019 - 03 avr 2019 • Singapore, Singapour
Résumé:
This “State of Control” is achieved by having a set of Quality Systems that provide a documented context within which to manufacture and test drugs. In the late 1990’s the US FDA, the European Agencies and Japan began an effort to standardize regulator expectations for cGMP manufacturing. This culminated in a series of Quality Guidances under the banner of the International Conference on Harmonization (ICH). The ICH guidances that cover Quality aspects (listed Q1 through Q12) define the high level expectation for maintaining a State of Control.
Contact:
Tél.: [8887172436];     Email.: referral@complianceonline.com
Sujets:
"pharma quality management workshop, good manufacturing practices (cGMP), ICH guidance for pharma quality management, ICH-Q7, ICH-Q8, ICH-Q9, ICH-Q10, ICH-Q11, Quality by Design (QbD), 21 CFR Part 11, MHRA guidance on data integrity, 21 CFR 314 for post market surveillance, ICH-Q9 Risk Management, SOPs, contamination control, vendor/supplier qualification, packaging operations, GMP lab, stability program, change Control"
Identifiant de l'évènement:
1182851
3
FDA eCTD Training Seminar — eCTD Submissions of IND and NDA/BLA to the US FDA
04 avr 2019 • Washington DC, États-Unis
Résumé:
The eCTD training workshop will provide the attendees with step-by-step instructions in creating and submitting eCTD submissions for IND, NDA, BLA, and ANDA applications without the need for expensive tools or unreasonable efforts. This no-frills workshop aims to train in the minimum skills needed and provide hands-on practical tips to create eCTD submissions. The trainers will use their own case studies of how eCTD submissions were created and successfully submitted to the FDA using indigenous tools and expertise. Also discussed will be logistical issues associated with managing and maintaining eCTD compliance with regards to all regulatory submissions. This workshop will be beneficial to both the novices and experienced in the field.
Contact:
Tél.: [410 501 5777];     Email.: pkumar@fdamap.com
Identifiant de l'évènement:
1177332
4
Canadian Academy Of Psychiatry And The Law Annual Conference 2019
28 avr 2019 - 01 mai 2019 • West Montréal , QC, Canada
Identifiant de l'évènement:
1143600
Sujets apparentés:
5
FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
09 mai 2019 - 10 mai 2019 • Boston, États-Unis
Résumé:
Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements. The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.
Contact:
Tél.: [+410 501 5777];     Email.: pkumar@fdamap.com
Identifiant de l'évènement:
1196550
6
Clinical Project Management Training — One Day Online Training in Clinical Project Management
20 mai 2019 • Washington DC, États-Unis
Résumé:
Clinical trials are highly regulated multi-dimensional projects that require constant interactions between the regulators and the sponsors, investigators, other personnel, and even patients involved in the conduct of a given trial. There are many diverse tasks involved in the conduct of a clinical trial starting from the development of a clinical trial protocol, finding and starting clinical trial sites, filing of an IND or IDE application, approvals from IRBs, numerous documents need to be collected to demonstrate compliance with regulations; managing supplies, collecting data, writing reports, and many other things. Clinical project managers need to understand, implement, and trouble-shoot practically all aspects of the clinical trial under them. Clinical project managers have to build teams and have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. This one-of-a-kind program will train you in regulatory affairs, clinical operations, monitoring, patient recruitment and retention, planning, medical writing, safety monitoring and practically all major aspects of running a clinical trial.
Contact:
Tél.: [+410 501 5777];     Email.: pkumar@fdamap.com
Identifiant de l'évènement:
1196625
7
CRO2019 — CRO/Sponsor Summit
23 mai 2019 - 24 mai 2019 • Hyderabad, Inde
Résumé:
Ensuring the quality of the clinical data generated for regulatory submissions is a major challenge today for both the Clinical Research Organizations (CROs) as well as the Sponsors Pharmaceutical Organizations. Where on one hand, computerization, automation, and LIMS have helped in data management, on the other hand, it has also made data alterations much easier. Therefore, for regulatory success both the CRO conducting the study and the Sponsors have to play a pivotal role in ensuring quality in clinical studies.
Contact:
Tél.: [7986926833];     Email.: sb.jatinkashyap@gmail.com
Sujets:
Formulation Development, Regulatory Affairs, Analytical/Bio-analytical Development, Quality Control, Quality Assurance, Investigator Site Management, Outsourcing Management, Auditors, Clinical Research and Development, Analytical Method Development, IT & Data management, Pharmacovigilance, Medical Affairs R&D and Strategic issues, Business Development, CRO/Sponsors
Identifiant de l'évènement:
1182364
8
CTS — 10th Annual Clinical Trials Summit 2019
28 mai 2019 • Mumbai, Inde
Résumé:
10th Annual Clinical Trials Summit 2019 is inspiring keynote presentations, plenary talks and panel discussions. This will discuss most recent techniques, developments, novel strategies and various disciplines involved in drug discovery, clinical research, patient centricity, clinical site & supply management, medical imaging, data management and outsourcing in clinical trials. It will educate healthcare and clinical researcher professionals about design, operation, organizing, research computing, regulatory aspects and reporting of clinical trials.
Contact:
Tél.: [+91 44 24762472];     Email.: kavitha@virtueinsight.co.in
Sujets:
Clinical Research & Development, Clinical Research Services, Clinical Operations, Clinical Data Management, Clinical IT, Clinical Trials, Medical Affairs, Regulatory affairs, Compliance
Identifiant de l'évènement:
1202600
9
510(k) Submissions to the FDA: Hands-On Workshop
11 jul 2019 - 12 jul 2019 • Boston, États-Unis
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.

Contact:
Tél.: [+410 501 5777];     Email.: pkumar@fdamap.com
Sujets:
FDA 510(k) Approval, 510(k) Clearance, FDA 510(k) Submission, FDA Submissions, 510(k) Application, FDA 510(k) Strategy, FDA Clarence, FDA Approval
Identifiant de l'évènement:
1200294
10
ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
23 sep 2019 - 25 sep 2019 • Washington, D.C., États-Unis
Organisateur:
American Statistical Association
Identifiant de l'évènement:
1145492


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Dernière mise à jour: 03 Mars 2019