Conférences - Législation en médecine et pharmacologie

Sélecionner un pays:
Allemagne (2) - Belgique (1) - Inde (1) - Italie (1) - Royaume-Uni (2) - États-Unis (9)

TOUS LES PAYS

1
FDA’s GMP Manufacturing Practices Regulations — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
25 oct 2018 - 26 oct 2018 • Boston, États-Unis
Résumé:
This 2 day 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. Learning Objectives: Learn about FDA's regulations and Guidance, Documents for Phase I clinical trials, Key elements of GMP for Phase I clinical trials, Best Practices for manufacturing drugs and biologics for early clinical trials, Components for the CMC information for INDs, Raw material management, Risk management for manufacturing early clinical stage material, Outsourcing early stage manufacturing.
Contact:
Tél.: [410-501-5777];     Email.: pbrown@fdamap.com
Sujets:
Clinical trials, FDA Clinical Trial Regulations, FDA GMP Guidance, GMP Phase 1, Investigational New Products, FDA GMP Regulations, INDs, Good Manufacturing Practices
Identifiant de l'évènement:
1122226
2
International Conference „Genome Editing under Gene Technology Law: Legal Aspects and Latest Developments
06 nov 2018 • Berlin, Allemagne
Résumé:
In the past years, the debate concerning the applicability of European genetic engineering law on new gene techniques (“genome editing”) was very lively held. With its ruling of 07/25/2018 the European Court of Justice found clear words to provide certainty: So-called new technologies shall comply with the precautionary principle and must meet the requirements of genetic engineering law. Nevertheless, due to economic interests and transatlantic connections an end to the conflict cannot be expected. Within the framework of our conference, distinguished experts investigate how biotech applications in agriculture will develop after the ruling of the ECJ.
Contact:
Email.: mitarbeiter.spranger@jura.uni-bonn.de
Sujets:
Biotechnologierecht, Gene Technology Law, Genetic Engineering, Genome Editing
Identifiant de l'évènement:
1129490
3
Pharmacovigilance Strategy Meeting US East Coast 2018
07 nov 2018 • Massachusetts, États-Unis
Contact:
Tél.: [2070961222];     Email.: jp@proventainternational.com
Sujets:
regulatory affairs, compliance, epidemiology, drug safety, risk management
Identifiant de l'évènement:
1068030
4
Course — Filing Variations in the European Union
07 nov 2018 - 08 nov 2018 • Berlin, Allemagne
Résumé:
The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections.
Contact:
Tél.: [+1-610-648-7550];     Email.: info@cfpie.com
Sujets:
filing, extensions, Marketing Authorizations, filing variations, CMD, Submission, Timeline
Identifiant de l'évènement:
1012517
5
Regulatory Affairs Strategy Meeting US East Coast 2018
08 nov 2018 • Massachusetts, États-Unis
Contact:
Tél.: [2070961222];     Email.: jp@proventainternational.com
Sujets:
regulatory affairs, compliance, epidemiology, drug safety, risk management, medical safety
Identifiant de l'évènement:
1068040
6
online — Which are Compliant for Inspections for a [GXP Compliance]
12 nov 2018 • Fremont, États-Unis
Contact:
Event Manager;     Tél.: [18004479407];     Email.: support@compliance4All.com
Sujets:
FDA Calibration, Validation of Laboratory, Instrumentation, calibration of pharmaceutical instruments, medical device calibration, fda calibration requirements, calibration requirements, calibration procedure medical equipments
Identifiant de l'évènement:
1126361
7
online — When Conducting cGMP Regulatory Inspections
13 nov 2018 • Fremont, États-Unis
Contact:
Event Manager;     Tél.: [18004479407];     Email.: support@compliance4All.com
Sujets:
Quality Control, Quality Assurance, Senior Management, Project Managers
Identifiant de l'évènement:
1126477
8
17th Pharmacovigilance 2018
15 nov 2018 • Mumbai, Inde
Résumé:
Virtue Insight is glad to announce 17th Pharmacovigilance 2018 to be held on 15th November 2018 in Mumbai, India. It focuses on the advancements in Pharmacovigilance, Risk Management, and Drug Safety. The field of Pharmacovigilance is growing rapidly and its development is making tremendous impacts in medical sciences and pharmaceuticals. 17th Pharmacovigilance 2018 emphasizes on how the importance and significance can be gauged by the fact that it has made huge advancements over the course of time and is continuing to influence various sectors.
Contact:
Tél.: [+91 44 24762472];     Email.: kavitha@virtueinsight.co.in
Sujets:
pharmacovigilance, regulatoryaffairs, regulations, pharmaceutical, healthcare, drug safety,
Identifiant de l'évènement:
1127497
9
Euro toxi summit 2018 — Euro Summit on Toxicology & Pharmacology
19 nov 2018 - 21 nov 2018 • Rome, Italie
Résumé:
Scient Open Access extends an enthusiastic and sincere welcome to the Euro Summit on Toxicology & Pharmacology which is set to hit the calendar in November 19-21 at Rome, Italy. The Euro Toxicology Conference is the nation’s biggest, most influential collaboration of professionals dedicated to Toxicology & Pharmacology.
Contact:
Tél.: [15199000130];     Email.: genotoxicology@scientonline.org
Sujets:
Scientific Sessions Track 1 Toxicology Track 2 Applied Toxicology Track 3 Drug Toxicology Track 4 Pharmacology and Toxicology Track 5 Environmental Toxicology Track 6 Immunotoxicology Track 7 Applied Pharmacology Track 8 Forensic Toxicology Track 9 Reproductive Toxicology Track 10 Genetic Toxicology Track 11 Toxicology Current Advances Track 12 Industrial & Occupational Toxicology Track 13 Trending Toxicology Concepts Track 14 Computational toxicology Track 15 Clinical Pharmacology Track 16 Cardiovascular Pharmacology
Identifiant de l'évènement:
1053336
10
online — Guidance for Electronic Records and Electronic Signatures used in FDA
27 nov 2018 • Fremont, États-Unis
Contact:
Event Manager;     Tél.: [18004479407];     Email.: support@compliance4All.com
Sujets:
Clinical Data Managers and Scientists, Compliance Managers and Auditors, Lab Managers and Analysts
Identifiant de l'évènement:
1126410
11
The Pharmaceutical Out-licensing Course
27 nov 2018 - 28 nov 2018 • Bruxelles, Belgique
Résumé:
Be able to decide on the best deal type for products in R&D – Know what to include in CDAs, MTAs and term sheets – Learn how to prepare product information and how to find potential partners – Know how to calculate the value of your product and optimise the deal structure.
Contact:
Tél.: [+32 2 709 01 42];     Email.: annelies.swaan@celforpharma.com
Identifiant de l'évènement:
1009932
12
online — Medical Device Single Audit Program (MDSAP) Preparation
30 nov 2018 • Fremont, États-Unis
Contact:
Event Manager;     Tél.: [18004479407];     Email.: support@compliance4All.com
Sujets:
Corporate Management, Quality Management, Regulatory Management, Sales & Marketing Management
Identifiant de l'évènement:
1126497
13
online — How to Audit Against ICH GCP 2 Addendum to Ensure Compliance
30 nov 2018 • Fremont, États-Unis
Contact:
Event Manager;     Tél.: [18004479407];     Email.: support@compliance4All.com
Sujets:
Clinical Research, Clinical Operations, Regulatory Affairs, CRO, Regulatory Authorities, Clinical Trial Personnel Quality Assurance
Identifiant de l'évènement:
1126529
14
QBD & PAT 2018 conference
03 dec 2018 - 04 dec 2018 • Londres, Royaume-Uni
Résumé:
QbD & PAT conference will bring together participants from industry, academia and regulatory creating invaluable opportunity to discuss the recent developments, future trends, challenges and Solutions for development & Manufacturing of Pharmaceutical & Biotechnology products. The conference will focus on discussing the existing challenges and explore practical applications related to drug development, manufacturing and regulatory. It's a 2-day program which will include presentations, talks, case studies, panel & Round-table discussions from industry leaders, solution providers, and academia.
Contact:
Tél.: [9876543210];     Email.: marketing@biotrains.com
Sujets:
quality development, manufacturing, pharma designing, biotech
Identifiant de l'évènement:
1109597
15
FDA Technical and Regulatory Writing — Technical and Regulatory Writing for FDA-Regulated Industry
06 dec 2018 - 07 dec 2018 • Boston, États-Unis
Résumé:
This one-of-a-kind workshop will provide technical, practical, logical and logistical tips for regulatory writers of all levels of skills. This 2 day workshop will address best practices, and regulatory strategies on how to write effective documents covering anywhere from simple issues such as minutes of meetings and correspondence notes, to highly sophisticated nonclinical and clinical study reports, and regulatory submissions to FDA, EMA, Health Canada, and other regulators. The trainers will provide practical tips using examples on how to organize and deliver information into clear and readable documents, and how to edit, format, present and publish technical regulatory documents for most favorable reception by the regulatory agencies. The workshop will also discuss rules for writing documents intended for electronic submission to regulatory agencies.
Contact:
Tél.: [410-501-5777];     Email.: pbrown@fdamap.com
Sujets:
FDA Technical Writing, FDA Regulatory Writing, FDA Documentation, Medical Writing, FDA Technical Documents, Regulatory Writing Skills
Identifiant de l'évènement:
1122192
16
Course — Manufacturing Sterile Products
12 dec 2018 • Reading, Royaume-Uni
Résumé:
This course provides an extensive introduction to the regulatory requirements governing pharmaceutical clean room operation, and details the aseptic filling and terminal sterilisation methods for producing sterile products. The delegates will gain an appreciation of the significance of sterile products to the patient, and understand why there is intensive regulatory interest worldwide in the control of sterile product manufacture.
Identifiant de l'évènement:
1104275


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Dernière mise jour: 09 Octobre 2018