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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 20:12:20
Managing Clinical Trials   by  on 2010-07-16 00:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 18:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 18:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 17:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 17:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 19:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 19:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 09:40:32
The Wall Street Journal's special supplement on clinical trials   by  on 2010-05-01 09:31:52
Major developments in EU Clinical Trial Guidances   by  on 2010-04-21 03:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by  on 2010-04-19 07:16:06
Newer Antibacterial Drugs for a New Century   by  on 2010-04-19 06:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by  on 2010-04-13 15:57:20
Practice Guidelines for Chronic Pain Management   by  on 2010-04-05 04:52:16
CONSORT III (2010)   by  on 2010-03-29 20:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 20:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 22:07:46
US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-26 04:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by  on 2010-02-06 20:12:14
UK-MHRA's Response to the Review of the Clinical Trials Directive   by  on 2010-01-27 19:19:01
US-FDA revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Conduct of CT   by  on 2010-01-22 18:07:03
US-FDA Draft Guidance Recommends DSMBs, CECs for Heart Valve Studies   by  on 2010-01-21 19:22:51
FDA Issues Draft Guidance on IRB Continuing Review   by  on 2010-01-14 04:07:29
FDA's proposed rule on Post-marketing Safety Reporting for Combination Prodcuts   by  on 2010-01-12 20:15:13
PhRMA: More than 800 Medicines and Vaccines in Clinical Trials for Cancer   by  on 2010-01-11 04:23:31
PhRMA Report says 97 Medicines and Vaccines Now in Development for HIV/AIDS   by  on 2010-01-11 04:00:18
EMEA Guidelines on Cystic Fibrosis Drug Development   by  on 2010-01-05 17:14:16
US-FDA' proposed rule on Informed Consent regulations   by  on 2010-01-03 06:22:47
US FDA Warning Letters in Clinical Investigation for the Month of December 2009   by  on 2009-12-31 17:10:00
International Compilation of Human Research Protections 2010 Edition   by  on 2009-12-23 22:59:39
ASE Expert Consensus Statement: Echocardiographic Imaging in Clinical Trials   by  on 2009-12-18 04:11:05
USFDA's Final Guidance for Industry Patient-Reported Outcome Measures   by  on 2009-12-18 03:21:16
New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP   by  on 2009-12-05 02:55:35
Ethical Guidelines for Intervention Studies in New Zealand   by  on 2009-11-30 18:28:34
Medical Device Control Office, DOH, Hong Kong invites public comments on guidance   by  on 2009-11-21 15:57:50
Companies to Disclose All Clinical Trials in Patients   by  on 2009-11-19 17:25:20
Office for Human Research Protections (OHRP): Requests for Public Comment   by  on 2009-11-09 17:38:15
HL7 Announces Industry’s First EHR-S Functional Requirements Standard for Clinical Research   by  on 2009-11-09 06:28:30
PhRMA's New Clinical Trial Guidelines   by  on 2009-10-05 18:21:30
 Subject :NIH's Financial Conflict of Interest (FCOI) Proposed Rule.. 2010-05-27 19:42:00 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : NIH's Financial Conflict of Interest (FCOI) Proposed Rule

Dear Friends,
 
Partnerships between NIH-funded researchers and industry are often essential to the process of moving discoveries from the bench to the bedside. However, managing Financial Conflicts of Interest (FCOI) can be a major challenge because of the complex relationships among government, academia, and industry. A Notice of Proposed Rulemaking, which is open for public comment for the next 60 days, proposes a general revision to the existing regulations.

Information about the Notice of Proposed Rule Making is available at: http://www.gpo.gov/fdsys/pkg/FR-2010-05-21/pdf/2010-11885.pdf

A replay of the telebriefing with NIH Director Francis S. Collins, M.D., Ph.D. is available at: http://ocplmedia.od.nih.gov/nihradio/NIHtelebrifing-2010.05.20.mp3
 
Kind regards,

 

 

 
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GCP HelpDesk
 Subject :AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drug.. 2010-05-13 22:55:29 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
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Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population

Subject :AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population

Dear Friends,
 
Please find attached American Academy of Pediatrics’ Clinical Report—Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations.
 
The proper ethical conduct of studies to evaluate drugs in children is of paramount importance to all those involved in these types of studies. This report is an updated revision to the previously published guidelines from the American Academy of Pediatrics in 1995. Since the previous publication, there have been great strides made in the science and ethics of studying drugs in children. There have also been numerous legislative and regulatory advancements that have promoted the study of drugs in children while simultaneously allowing for the protection of this particularly vulnerable group. This report summarizes these changes and advances and provides a framework from which to guide and monitor the ethical conduct of studies to evaluate drugs in children.
 
Kind regards,

Attachments
 Ethical Gudelines for Clinical Trials_Paediatrics.pdf [102 KB] ::
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Last Edited On: 2010-05-13 22:55:29 By GCP HelpDesk for the Reason
GCP HelpDesk
 Subject :Argentina: ANMAT - new regulatory update.. 2010-05-01 09:40:32 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : Argentina: ANMAT - new regulatory update

Dear Friends,

On April 15 th the new controller for ANMAT, Dr. Carlos Chiale circulated a new regulatory update, indicating that the protocols for Phase I and II with new products must be submitted directly to INAME entrance desk..

The objective of this amendment is to accelerate the time assessments for the mentioned cases.

http://www.anmat.gov.ar/medicamentos/investigacion_clinica.asp

Kind regards,
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GCP HelpDesk
 Subject :The Wall Street Journal's special supplement on clinical trials.. 2010-05-01 09:31:52 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Forum : Clinical Research/Trials Updates
Topic : The Wall Street Journal's special supplement on clinical trials

Dear Friends,
 
The Wall Street Journal has published a special supplement about clinical trials to promote public awareness for clinical trials.
 
It is printed in the April 23rd issue. Here is a PDF version of the supplement.
 
Happy reading..!
 
Kind regards, 

Attachments
 Your Guide to Clinical Trials.pdf [893 KB] ::
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GCP HelpDesk
 Subject :EFGCP:Procedure for the Ethical Review of Protocols in Turkey.. 2010-05-01 06:35:05 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : EFGCP:Procedure for the Ethical Review of Protocols in Turkey

Dear friends,
 
Please find attached EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe - Turkey.
 
Kind regards, 

Attachments
 EFGCP Report-Turkey April 2010.doc [383 KB] ::
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GCP HelpDesk
 Subject :New class of Anticancer agents.. 2010-04-27 16:16:47 
Sree
Newbie
Joined: 2009-09-18 20:04:52
Posts: 16
Location: 
Forum : Clinical Research/Trials Updates
Topic : New class of Anticancer agents

Dear Friends,

Agents tageting small interfering RNAs (siRNA) for use in cancer have been developed. The phase 1 clinical trials are over and the results were recently published in Nature.  CALAA-01 is a nanoparticle drug containing small interfering RNAs targeted to ribonucleside reductase M2. This is used in solid tumors that are refractory to therapy. This opens an entirely new class of anticancer agents. Please find attached a commentary on the original research published in Nature.

Kind regards,


Attachments
 New class of anticancer agents.pdf [197 KB] ::
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 Subject :Major developments in EU Clinical Trial Guidances.. 2010-04-21 03:13:23 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : Major developments in EU Clinical Trial Guidances

Dear Friends,

Please find the major developments in clinical trials in Europe.

30/03/2010 :Summary of the Responses to the public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC". This document summarises the responses to the public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC"

Revision of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (Version of March 2010). This Document is available in Volume 10 of EudraLex.

Guidance documents applying to clinical trials - Questions & Answers Document, Version 5.0 (March 2010). The Questions and Answers document in the EudraLex chapter on clinical trials has been revised. This document is available in Volume 10 of EudraLex.

Annex VI to Guidance for the conduct of GCP inspections - Record keeping and archiving of documents (March 2010).

Kind regards,
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Last Edited On: 2010-04-21 03:13:23 By GCP HelpDesk for the Reason
GCP HelpDesk
 Subject :Analysis of the adverse reactions induced by natural product-derived d.. 2010-04-19 07:16:06 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Forum : Pharmacovigilance and Drug Safety
Topic : Analysis of the adverse reactions induced by natural product-derived drugs

Subject :Analysis of the adverse reactions induced by natural product-derived drugs

Dear Friends,

Please find attached article on Analysis of the adverse reactions induced by natural product-derived drugs.

Kind regards,


Attachments
 ADRs of natural product derived drugs.pdf [201 KB] ::
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GCP HelpDesk
 Subject :Newer Antibacterial Drugs for a New Century.. 2010-04-19 06:49:47 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Forum : Clinical Research/Trials Updates
Topic : Newer Antibacterial Drugs for a New Century

Dear Friends,
 
Please find attached article on Newer Antibacterial Drugs.
 
These new drugs belong to the following classes of compounds that include:
  • Oxazolidinones
  • Glycopeptides
  • Ketolides
  • Glycylcyclines
  • Carbapenems
  • Fluoroquinolones
 
Kind regards,

Attachments
 Newer antibacterial agents.pdf [381 KB] ::
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GCP HelpDesk
 Subject :Career Opportunities in Clinical Pharmacology.. 2010-04-19 07:07:51 
Sathvika
Newbie
Joined: 2009-07-28 23:25:14
Posts: 20
Location: 
Forum : Career Discussion
Topic : Career Opportunities in Clinical Pharmacology

Dear Friends,

Please find attached article on Career Opportunities in Clinical Pharmacology.

Kind regards,


Attachments
 Career opportunities in Clinical Pharmacology.pdf [175 KB] ::
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Last Edited On: 2010-04-19 07:07:51 By Sathvika for the Reason
 Subject :Deming's 14 Principles-Aricle from BARQA.. 2010-04-19 07:04:59 
Leon
Newbie
Joined: 2009-07-13 19:19:42
Posts: 23
Location: 
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : Deming's 14 Principles-Aricle from BARQA

Dear Friends,

Please find attached BARQA article on Deming's 14 Principles.

Kind regards,


Attachments
 Deming.pdf [220 KB] ::
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Last Edited On: 2010-04-19 07:04:59 By Leon for the Reason
 Subject :Newer Non-Statin Drugs for Reducing Cholesterol.. 2010-04-13 15:57:20 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Newer Non-Statin Drugs for Reducing Cholesterol

Dear Friends, 
 
Please find attached a review article which gives the newer nonstatin drugs for reducing cholesterol. 
 
The newer agents are  
 
Lapaquistat:squalene synthase inhibitor
Implitapide:Microsomal triglyceride transport protein inhibitor
Mipomersen: ApoB100 Antisense oligonucelotide 
 
Kind regards,

Attachments
 Newer drugs to reduce cholesterol.pdf [314 KB] ::
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GCP HelpDesk
 Subject :Practice Guidelines for Chronic Pain Management.. 2010-04-05 04:52:16 
GCP HelpDesk
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Posts: 62
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Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Practice Guidelines for Chronic Pain Management

Dear Friends, 
 
For the first time in more than a decade, an American Society of Anesthesiologists taskforce has updated its chronic pain guidelines.The new recommendations are designed to help clinicians who treat pain.
 
The objectives are to optimize pain control, enhance physical and psychological well-being, and minimize adverse outcomes.Richard Rosenquist, MD, from the University of Iowa Hospital, Iowa City, led the 12-member taskforce of anesthesiologists in both private and academic practice from various parts of the United States. The group also worked with members of the American Society of Regional Anesthesia and Pain Medicine.
 
The new guidelines appear in the April issue of Anesthesiology.The recommendations apply to patients with chronic noncancer, neuropathic, somatic, or visceral pain. The taskforce focused on interventional diagnostic procedures including diagnostic joint block, nerve block, and neuraxial opioid trials.   
 
Kind regards,  

Attachments
 Practice_Guidelines_for_Chronic_Pain_Management_.13.pdf [695 KB] ::
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 Subject :CONSORT III (2010).. 2010-03-29 20:53:28 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : CONSORT III (2010)

Dear Friends,
 
The CONSORT (Consolidated Standards of Reporting Trials) guidelines third revision was released recently. CONSORT guidelines were established in 1996 and the second revision was made in 2001.
 
Please find attached articles published in BMJ (And also in many other journals). The first one gives the significant changes made in CONSORT 2010 and the other is an elaborated explanation of every item in CONSORT 2010.
 
Kind regards,

Attachments
 Changes in CONSORT 2010.pdf [313 KB] ::
 CONSORT III.pdf [636 KB] ::
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 Subject :US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Re.. 2010-03-20 20:25:16 
GCP HelpDesk
Moderator
Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function

Subject :US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function

Dear Friends,

US FDA issued Draft Guidance for Industry on Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling. To access this document click here

Kind regards,

 
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GCP HelpDesk
 Subject :US-FDA issues First Draft Guidance on Noninferiority Trials.. 2010-03-04 22:07:46 
GCP HelpDesk
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Posts: 62
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Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : US-FDA issues First Draft Guidance on Noninferiority Trials

Dear Friends,
 
The FDA has proposed the first draft guidance on noninferiority (NI) clinical trials, which may help increase the availability of comparative information on drugs. NI trials compare a new drug with a proven drug to determine whether the new drug is less effective by an unacceptable margin. The major focus of the guidance is determining the NI margin, which must be estimated based on past performance of the active control drug and by comparing other test conditions to the current environment, according to the draft guidance. Comments are due May 30.
 
Kind regards,
 
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GCP HelpDesk
 Subject :US FDA new rule on reporting information regarding falsification of d.. 2010-02-26 04:47:33 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
Posts: 62
Location: 
Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : US FDA new rule on reporting information regarding falsification of data

Subject :US FDA new rule on reporting information regarding falsification of data

Dear Friends,

The Food and Drug Administration is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data involving studies including, but not limited to, clinical investigators, nonclinical laboratory studies, and clinical studies in animals.

The proposed rule is now available using the following web link: http://edocket.access.gpo.gov/2010/pdf/2010-3123.pdf.

Comments to this proposed rule are due by May 20, 2010.

Kind regards,
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GCP HelpDesk
 Subject :Senior CRA (Late Phase) - Global CROs - Various European locations.. 2010-02-12 00:41:09 
Karina
Newbie
Joined: 2010-02-11 16:27:35
Posts: 2
Location: 
Forum : Jobs in EUROPE
Topic : Senior CRA (Late Phase) - Global CROs - Various European locations

Dear Members,

Are you an experienced CRA with late phase experience agained within a CRO environment?

I have several exciting opportunities working for my clients top 10 global CROs within various European locations.
Please contact me to discuss these opportunities in questions further on +44 (0) 1727 86 55 33/ karinabharadia@levynet.co.uk .

 Many thanks.
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 Subject :Clinical Project Managers - Global CRO- Various UK locations.. 2010-02-12 00:36:21 
Karina
Newbie
Joined: 2010-02-11 16:27:35
Posts: 2
Location: 
Forum : Jobs in EUROPE
Topic : Clinical Project Managers - Global CRO- Various UK locations

Dear Members, 

Are you an experienced Clinical Project Manager searching for a new challenging within a progressive and dynamic environment?If so please contact me to discuss more about Clinical Project Manager/Leader opportunities further on +44 (0) 1727 86 55 33 or email karinabharadia@levynet.co.uk for further information.

Many thanks,Karina

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 Subject :Update on three new drugs - ambrisentan, golimumab and lacosamide.. 2010-02-11 00:02:29 
Harrison
Newbie
Joined: 2009-07-13 23:53:04
Posts: 31
Location: 
  • 4294967292
Forum : Clinical Research/Trials Updates
Topic : Update on three new drugs - ambrisentan, golimumab and lacosamide

Dear Friends, 

Please find attached an update on three new drugs - ambrisentan, golimumab and lacosamide. 

Kind regards,  


Attachments
 NewDrugUpdates.pdf [143 KB] ::
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