Conférences - Législation en médecine et pharmacologie

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Inde (2) - Royaume-Uni (8) - Suisse (1) - États-Unis (8)

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1
Training — Clinical Audit Masterclass
27 nov 2017 • Londres, Royaume-Uni
Résumé:
This one day clinical audit masterclass will provide you with a full understanding of why clinical audit is important to organisations, teams and individuals (e.g. helping to meet your revalidation requirements). You will also be able to look at real life clinical audit projects, giving you the opportunity to see first hand what makes a good clinical audit report. The day will help you to identify and overcome the barriers and resistance to clinical audit and culminates with a look at what will be coming next for clinical audit in future years. A 20% discount is available by quoting ref: hcuk20c-s when booking.
Contact:
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Tél.: 0044/1932 429933;     Email.: kerry@hc-uk.org.uk
Sujets:
Clinical Audit
Identifiant de l'évènement:
950959
2
1 Day Seminar — 2017 workshop GMP’s in practice: quality systems, common sense compliance, and application
07 dec 2017 • Washington, Inde
Résumé:
Course"GMP’s in practice: quality systems, common sense compliance, and application" has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion
Contact:
Conference Manager;     Tél.: [347 282-5400];     Email.: support@worldcomplianceseminars.in
Identifiant de l'évènement:
951812
3
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
07 dec 2017 - 08 dec 2017 • Research Triangle, États-Unis
Résumé:
One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact:
Referral;     Tél.: [8887172436];     Email.: referral@complianceonline.com
Sujets:
FDA SOP requirements, FDA SOPs, FDA regulated industry SOP types, FDA SOP components, SOP training, SOP implementation, SOP template
Identifiant de l'évènement:
913972
4
Training — In-depth legal masterclass: Informed Consent After Lanarkshire
13 dec 2017 • Londres, Royaume-Uni
Résumé:
This one-day course will cover all elements of informed consent as well as the law relating to treatment of those who lack capacity and who are unable to give informed consent. A 20% discount is available by quoting ref: hcuk20c-s when booking.
Contact:
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Tél.: 0044/1932 429933;     Email.: kerry@hc-uk.org.uk
Sujets:
Informed Consent, Law
Identifiant de l'évènement:
951125
5
COLD CHAIN — SMi's 12th annual Cold Chain Distribution Conference and Exhibition
13 dec 2017 - 14 dec 2017 • Londres, Royaume-Uni
Résumé:
As the global healthcare industry grows, temperature controlled logistics rapidly evolves along with it. Factors such as the ever-changing regulatory requirements, diverse array of biopharma products entering the markets, and new technology emerging daily, are causing companies to face the challenge of constantly adapting their supply chain processes and staying ahead of the curve. Responding to the evolution within the industry, SMi is proud to announce the return of its leading 12th annual Cold Chain Distribution event. Returning to London in December, this year's event will remain at the forefront of innovation. With huge interest from leaders in the field, we have worked closely with an expert panel of speakers to present an agenda that is shaping up to be the best Cold Chain Distribution event. This year's event will continue to lead with its unrivaled panel of experts bringing you the most insightful presentations from our confirmed Industry-leading speakers from: Exelsius, Sanofi Genzyme, World Courier, Modalis, Eli Lilly, EMBALL'ISO, GlaxoSmithKline, World Health Organization, European Association of Pharmaceutical Full Line-Wholesalers (GIRP), National Institute for Biological Standards And Control, SeerPharma (UK), Merck SpA and many more!
Contact:
Kyra Williams;     Tél.: [2078276012];     Email.: kwilliams@smi-online.co.uk
Sujets:
GDP Guidelines, Cold Chain Distribution, Temperature Control, Supply Chain, Logistics, Temperature Monitoring, Stability Studies
Identifiant de l'évènement:
918859
6
Workshop — 2 Days Workshop: Excel spreadsheet validation 2018: tools and techniques to meet FDA requirements
14 dec 2017 - 15 dec 2017 • Hollywood, États-Unis
Résumé:
Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment. GxP records generated by spreadsheet calculations are electronic records and should comply with FDA’s 21 CFR Part 11 and the European Annex 11. For critical records Part 11 controls, such as data accuracy and data integrity, should be implemented. Currently there are no specific industry FDA guidelines on using spreadsheets in regulated environments. However, the flexibility and power of the spreadsheet allows users to create tools that range from performing simple calculations to sophisticated analysis of a major clinical study, or laboratory or manufacturing data.
Contact:
Conference Manager;     Tél.: [347 282-5400];     Email.: support@worldcomplianceseminars.in
Identifiant de l'évènement:
964248
7
AICTE Sponsored International Conference on Challenges, Opportunities and Newer Directions of Pharmacovigilance and Clinical Research in India
05 jan 2018 - 06 jan 2018 • Vadodara, Inde
Résumé:
This international conference will facilitate the delegates to learn newer horizons of clinical research, a branch of health care science that determines the safety and efficacy of medications, devices, diagnostic products and treatment regimens intended for human use. The Pharmacovigilance Programme of India (PvPI) started by the Ministry of Health and Family Welfare , Government of India will help to monitor the effects of marketed drugs especially to identify and evaluate previously unreported adverse reactions in Indian population. The conference will promote and strengthen the spontaneous reporting amongst medical / paramedical and pharmacy professionals. The expert sessions will help the delegates to become conversant with the newer career prospects and horizons in the profession.
Contact:
Dr. Madhavi Patel;     Tél.: [+91 94280 09213];     Email.: os.pippharmacon@paruluniversity.ac.in
Sujets:
Thrust Areas Preclinical and Clinical Trials, Drug Discovery and Development, Regulatory Updates on Drug Safety in India Pharmacovigilance Programme of India (PvPI), Developing Pharmacy Practice: A Focus on Patient Care, Pharmacogenomics and Pharmacoeconomics
Identifiant de l'évènement:
956190
8
Clinical Trial Regulatory Requirements
25 jan 2018 - 26 jan 2018 • Londres, Royaume-Uni
Résumé:
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.
Identifiant de l'évènement:
952420
Sujets apparentés:
9
RMPS — A Practical Guide to Writing Risk Management Plans
29 jan 2018 • Londres, Royaume-Uni
Résumé:
The new Pharmacovigilance Legislation of 2012 now requires companies to provide Risk Management Plans ( RMP s) and assessments for all new products whether those products are generic products or new chemical entities. If these are not done correctly this can delay both licensure and sales and damage the Company ability to maximise its products. Maintenance of the  RMP s also is an important aspect for maintaining the licence, compliance and these are reviewed in Regulatory Inspections. Can you afford not to get this right?
Identifiant de l'évènement:
952474
10
A Practical Guide to Producing and Maintaining the PSMF
30 jan 2018 • Londres, Royaume-Uni
Résumé:
This course will be relevant for anyone requiring a comprehensive overview of the Pharmacovigilance function and duties. It may be of particular interest to those who are responsible in Pharmacovigilance for any safety assessments and writing such plans including any EU QP PVs who approve such documents. Those who work with pharmacovigilance, e.g. Regulatory Affairs, Clinical, Sales & Marketing, Legal, Commercial and Quality and IT that must sign off such documents.
Identifiant de l'évènement:
957176
11
REMS — An Introduction to Risk Evaluation & Mitigation Strategies
31 jan 2018 • Londres, Royaume-Uni
Résumé:
The course will provide insight into the  FDA  thinking of which products qualify for a Risk Evaluation and Mitigation Strategies ( REMS ), the different categories of  REMS, their introduction and maintenance and the reporting assessments on the  REMS
Identifiant de l'évènement:
957141
12
Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation
05 fév 2018 - 09 fév 2018 • Boston, États-Unis
Résumé:
Tufts CSDD’s highly acclaimed, CME accredited, five-day Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation provides advanced instruction in practical and technical problem-solving in the areas of clinical pharmacology, drug development & clinical trial strategies, biopharmaceutical development, drug safety, and new drug regulation.

The course is designed to provide students with a broad and comprehensive understanding of issues related to the development and regulation of drugs, biologics, vaccines, devices, and in vitro diagnostics. Lectures focus on basic drug development topics - such as translational medicine, clinical pharmacology, epidemiology, drug regulation, and adverse drug event reporting - as well as broader - such as pharmacoeconomics, drug-device combinations, biosimilars, working with investigative sites, and drug marketing.

Educational Objectives for CME - at the conclusion of the activity, participants will be able to:

Clinical Pharmacology: Integrate the relevant pharmacology, pharmacokinetics, and statistics related to drug development and the nature of evidence required for proof of efficacy and safety.

Drug Development and Clinical Trials: Using a case-study approach, identify and solve practical, theoretical, and technical problems in human drug studies, and analyze an experimental design for a new drug candidate.

Regulation: Evaluate the science, laws, and regulations pertaining to the development and review of new drug products in the USA, Europe, Japan and other pharmaceutical markets.

*Groups of 3 or more receive discounted rates.

Contact:
Center for the Study of Drug Development (CSDD);     Tél.: [617-636-2170];     Email.: csdd@tufts.edu
Sujets:
Drug development, pharmacy, pharmacology, medicine, drug regulation, clinical research, clinical trials, academic, professional development
Identifiant de l'évènement:
950884
13
FDA's Medical Device Software Regulation Strategy
20 mar 2018 - 21 mar 2018 • Zurich, Suisse
Résumé:
The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.Note: Use coupon code < GET20 > and get 20% off on registration and this offer is not valid for with stay registration.
Contact:
Referral;     Tél.: [8887172436];     Email.: referral@complianceonline.com
Sujets:
Seminar by Ex-FDA Official, Regulatory profile for software products, FDA mobile apps regulation, medical device software functionality, FDA and NIST software guidance
Identifiant de l'évènement:
969681
14
The FDA Drug Approval Process
22 mar 2018 - 23 mar 2018 • Londres, Royaume-Uni
Résumé:
This seminar, by a US lawyer with over 40 years of experience dealing with pharmaceutical regulation in the United States and Europe, will provide a general introduction to all aspects of the US drug approval process. It will also cover the organisation and structure of the Food and Drug Administration, recent amendments to the FDA’s procedures designed to expedite the testing and approval of new medicines and other topics of current interest.
Identifiant de l'évènement:
956631
15
2nd Interim Analysis Symposium (EXL)A
26 mar 2018 - 27 mar 2018 • Philadelphia, PA, États-Unis
Résumé:
The 2nd Interim Analysis Symposium will provide drug safety and clinical operations teams with best practices and tried-and-true strategies that will enhance the capacity at which organizations can produce upstanding reports about the results of their ongoing studies and expedite effective products to market.
Identifiant de l'évènement:
956972
16
2nd Product Complaints Forum (EXL)A
26 mar 2018 - 27 mar 2018 • Philadelphia, PA, États-Unis
Résumé:
ExL Events’ 2nd Product Complaints Forum will provide insight into how to improve the management of product complaints and potential recalls. This program will feature case studies, panel sessions, and two tracks designed to deliver information for pharmaceutical, biotechnology, and medical device professionals involved in all stages of handling product complaints and potential recalls.
Identifiant de l'évènement:
956960
17
4th Annual ComplianceOnline Medical Device Summit 2018
07 jui 2018 - 08 jui 2018 • San Francisco, États-Unis
Résumé:
Plan for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections.
Contact:
Referral;     Tél.: [8887172436];     Email.: referral@complianceonline.com
Identifiant de l'évènement:
954430
18
Gordon Research Seminar — Drug Safety
09 jui 2018 - 10 jui 2018 • Stonehill College, Easton, MA, États-Unis
Sujets:
Drug Safety in the Modern Development Landscape: Innovations from Industry, Academia, and Government
Identifiant de l'évènement:
960022
19
Gordon Research Conference — Drug Safety
10 jui 2018 - 15 jui 2018 • Stonehill College, Easton, MA, États-Unis
Sujets:
Contemporary Advances and Challenges in Drug Safety Assessment
Identifiant de l'évènement:
960089


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Dernière mise à jour: 16 Novembre 2017