by chuck_ltd | 25 Nov, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence
This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies (NIS) in Mexico. Title: NIS Considerations – Mexico (2015) Publication Date: 24 November 2015 No. of Pages: 2o Format: PDF...
by chuck_ltd | 21 Nov, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence
Title: NIS Considerations – Slovenia (2015) Publication Date: 21 November 2015 No. of Pages: 21 Format: PDF Price: £50 Author/ Editor: Stuart McCully This short report provides details of the regulatory requirements and operational considerations when conducting...
by chuck_ltd | 20 Nov, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence
The Forum of International Research & Development Pharmaceutical Companies (the Forum) in co-operation with the independent scientific journal Medicina danes and Finance Business Academy organized the fourth annual conference The Value of Innovation. This year’s...
by chuck_ltd | 20 Nov, 2015 | CHCUK News & Articles, Consultation, News, NIS, Pragmatic Trials, Real Word Evidence
Proposed Revisions to Modernize, Strengthen, and make more Effective the Federal Policy for the Protection of Human Subjects Various US departments and agencies propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection...
by chuck_ltd | 18 Nov, 2015 | CHCUK News & Articles, Data Privacy, News, NIS
Background On October 6 2015 the European Court of Justice (ECJ) ruled that the European Commission decision on the adequacy of the EU-US safe harbour framework is invalid. ECJ Decision In Maximillian Schrems v Data Protection Commissioner (Case C-362/14) the ECJ held...
by chuck_ltd | 16 Nov, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Pragmatic Trials, Real Word Evidence
Morrison & Foerster LLP – Paul D. McKenzie and Wei Zhang One of the more dramatic privacy law developments in China in 2014 was the August criminal conviction of foreign nationals Peter Humphrey and Yu Yingzeng for their violation of Article 253 of the...
by chuck_ltd | 6 Nov, 2015 | CHCUK News & Articles, News, NIS
This page lists questions that marketing-authorisation holders (MAHs) may have on post-authorisation efficacy studies (PAESs). It provides an overview of the European Medicines Agency’s (EMA) position on issues that are typically addressed in discussions or...
by chuck_ltd | 6 Nov, 2015 | CHCUK News & Articles, News, NIS
This guidance is intended to provide scientific guidance for marketing-authorisation holders and national competent authorities on post-authorisation efficacy studies with regard to methodological considerations and the potential role of particular study designs. This...
by chuck_ltd | 5 Nov, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence
Ezekiel J. Emanuel, M.D., Ph.D. November 4, 2015DOI: 10.1056/NEJMp1512463 Background In 1972, Jean Heller of the Associated Press reported on a 40-year-old research study that had followed black Alabama sharecroppers, some of whom had syphilis. The revelation of...
by chuck_ltd | 3 Nov, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence
Over the past year, PCORI have more than doubled the number of rare disease studies in our research portfolio, and those 21 awards address a diverse set of conditions. PCORI’s authorizing law calls for a focus on rare diseases, which have been defined as conditions...
by chuck_ltd | 30 Oct, 2015 | CHCUK News & Articles, News, NIS, Publication Guidelines, Real Word Evidence
Problem statement Regulators may require marketing authorisation applicants/holders (MAAs/MAHs) to establish a registry in order to measure the safety or efficacy of individual products in routine clinical practice. Various challenges with regard to registries...
by chuck_ltd | 30 Oct, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Publication Guidelines
We are on the cusp of introducing a mechanism to disclose value transfers between health professionals and EFPIA Member Companies. But, with the June 2016 deadline looming, learning from those who are already experiencing this form of transparency could save us...
by chuck_ltd | 30 Oct, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Publication Guidelines
Although the Big Data revolution is only in its early days, the potential for value creation is huge in the healthcare sector. Not only can clinical data help us to understand diseases and develop therapies; it can also drive the transition towards modern health...
by chuck_ltd | 30 Oct, 2015 | CHCUK News & Articles, News, NIS, Publication Guidelines
The EFPIA disclosure code was transposed in to “The Ethical rules of the pharmaceutical Industry in Sweden” from 1 January 2014. Parallel to this actual code transposition, LIF also informed important stakeholders about the initiative trough meetings and personal...
by chuck_ltd | 27 Oct, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials
According to a consultation document released by the UKs Health Research Authority… In many cases we don’t always know (due to a lack of evidence) which of the large number of existing treatments routinely used in the NHS is best for an individual patient,...
by chuck_ltd | 26 Oct, 2015 | CHCUK News & Articles, NIS
PRAC Review Cycles 99 new protocols evaluated from July 2012 to July 2014 (26 imposed): Overal 150 protocols reviewed After one year of meetings, average of 15 protocols evaluated per month Median 2 rounds of review for imposed, and 1 round for non imposed Imposed/...
by chuck_ltd | 14 Oct, 2015 | CHCUK News & Articles, HTA, Medical Apps, News, NIS
Article by: Florian Eichmann, PhD, Principal Late Stage, Scientific Affairs and Real World Evidence, inVentiv Health Clinical, Munich, German Regulators and Health Technology Assessment (HTA) agencies – and thus manufacturers and research stakeholders –...
by chuck_ltd | 1 Oct, 2015 | CHCUK News & Articles, GCP, News, NIS
The recent approval by Britain’s National Health Service (NHS) for the use of electronic informed consent in a clinical trial is a pivotal moment in the global expansion of a technology that benefits both patients and sponsors of clinical research. Approval for the...
by chuck_ltd | 28 Sep, 2015 | CHCUK News & Articles, News, NIS
Acknowledgement: Prof David Hutchinson; www.canarybooks.com Three industry associations have challenged new legislation in France that allows the national regulator to temporarily authorise the use of a product in an unauthorised indication for economic reasons, even...
by chuck_ltd | 24 Sep, 2015 | CHCUK News & Articles, GCP, News, NIS
As deliberations on the General Data Protection Regulation (“GDPR”) between the trialogue parties European Parliament, European Council, and European Commission reach the final stages, the Conference of the Data Protection Commissioners of the German...
by chuck_ltd | 4 Sep, 2015 | CHCUK News & Articles, GCP, News, NIS
This week the HHS released a Notice of Proposed Rule Making (NPRM). This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. This...
by chuck_ltd | 1 Sep, 2015 | CHCUK News & Articles, News, NIS
The inventory of Drug Consumption Databases in Europe is a comprehensive and structured source of information on drug consumption in Europe. It comprises two documents. The master document contains a detailed report of the available information, methods to retrieve...
by chuck_ltd | 26 Aug, 2015 | CHCUK News & Articles, GCP, News, NIS
Vietnam’s regulatory information is now available in ClinRegs. Topic areas include: Competent Authority Oversight Ethics Committee Oversight Clinical Trial Lifecycle Sponsorship Informed Consent Investigational Products Specimens [Read...
by chuck_ltd | 20 Aug, 2015 | CHCUK News & Articles, News, NIS
ENCePP have released Revision 4, dated July 2015, with a revision or update of most chapters of the ‘Guide on Methodological Standards in Pharmacoepidemiology. The Guide on Methodological Standards in Pharmacoepidemiology offers a single web resource for...
by chuck_ltd | 18 Aug, 2015 | CHCUK News & Articles, NIS
Revision 2 of EMA GVP Module VIII has been released for public consultation Revision 2 contains the following: Changes to VIII.A., clarifying the link between the legislation on non-interventional PASS and categories 1-4 of non-interventional PASS described in GVP...
by chuck_ltd | 12 Mar, 2015 | CHCUK News & Articles, GCP, News, NIS
General information All clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive(126 KB) until the new Clinical Trials Regulation (CTR) EU No 536/2014 (875 KB) will become applicable, which will be...
by chuck_ltd | 11 Mar, 2015 | CHCUK News & Articles, GCP, News, NIS
As of 28 January 2015, the Medicines and Healthcare Products Regulatory Agency (MHRA) website is now on GOV.UK New web address is www.gov.uk/mhra. The contact has been rewritten so it is easier and clearer to understand. How does this affect you? Bookmarks and saved...
by chuck_ltd | 11 Mar, 2015 | CHCUK News & Articles, GCP, News, NIS
This draft guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including...
by chuck_ltd | 4 Jan, 2015 | News, NIS
Real-world data (RWD) is an umbrella term for different types of data that are not collected in conventional randomised controlled trials. RWD in the healthcare sector comes from various sources and includes patient data, data from clinicians, hospital data, data from...
by chuck_ltd | 25 Aug, 2014 | HTA, NIS
Using data from GP records in the Clinical Practice Research Datalink (CPRD), health researchers from the London School of Hygiene and Tropical Medicine conducted the largest study of its kind into the link between obesity and cancer. Overweight and obesity linked to...
by chuck_ltd | 20 Aug, 2014 | NIS
The Pharmig Code of Ethics was updated 1 July 2014: Ordinance 1/2014 stipulates new value limits for board and hospitality Must be lower than EUR 75.00 per person and meal (including taxes and/or charges and tips) [Read more…]
by chuck_ltd | 10 Apr, 2014 | CHCUK News & Articles, NIS
Delegated Regulation EU/357/2014 of 3 February 2014 was published in the official journal on the 10 April 2014 and will become effective on the 30 April 2014 Delegated Regulation EU/357/2014 of 3 February 2014 Supplementing Directive 2001/83/EC of the European...
by chuck_ltd | 19 Mar, 2014 | NIS
The European Medicines Agency has published the first summary for the public of the risk-management plan (RMP) of a newly authorised medicine. This RMP summary, which concerns the medicine Neuraceq, describes what is known and not known about the medicine’s safety and...
by chuck_ltd | 27 Feb, 2014 | NIS
Source: BBC Online Details on hospital admissions from 1989 to 2010 were handed to the Institute and Faculty of Actuaries. The information was used to produce a report to help insurance firms price their products. The Health and Social Care Information Centre, which...
by chuck_ltd | 20 Feb, 2014 | News, NIS
A new ARPIM Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals (HCP) and Healthcare Organisations (HCO) was published in Dec 2013. The new code is applicable from 1st January 2015. Applicability of the Code The Code...
by chuck_ltd | 20 Feb, 2014 | News, NIS
The ARPIM Code of Ethics was last amended in December 2013. The latest version of the ARPIM HCP Code is applicable from 1st April 2014. Revisions include: Obligation to Disclose NIS Studies: ARPIM members shall disclose their observational studies the relevant form...
by chuck_ltd | 20 Feb, 2014 | News, NIS
[Contributed by Mirela Tudor, Senior Specialist, Late Stage Submissions Group, inVentiv Health Clinical] The National Ethics Committee is now the “National Bioethics Committee of Medicines and Medical Devices (CNBMDM)” which has now taken full responsibility for...
by chuck_ltd | 15 Feb, 2014 | NIS
The Forum of International Research and Development Pharmaceutical Companies (FIRDPC) published the fowling two codes of practice on 11 December 2013: FIRDPC Code on Disclosure of Transfers of Value fromPharmaceutical Companies to Healthcare Professionals (Dec 2013)...
by chuck_ltd | 10 Feb, 2014 | NIS
Source: BBC News The authorities in Croatia have charged a pharmaceutical company and 364 people – most of them reportedly doctors – for allegedly rigging the drugs market. Senior managers at the drugs firm Farmal bribed a network of doctors and...
by chuck_ltd | 7 Feb, 2014 | NIS
Contributed by: Tara Isherwood, Manager, Late Stage Submissions Group, inVentiv Health Clinical Marketing authorisation holders are encouraged to complete a Good Pharmacovigilance Practice (GVP) compliance report every two years. The 2013 compliance report is now...
by chuck_ltd | 6 Feb, 2014 | NIS
The FDA draft ‘Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics’ is intended to describe FDA’s current thinking about how...
by chuck_ltd | 6 Feb, 2014 | NIS
The ‘Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products’ (EMA/281371/2013) has been released for public consultation as of 30 January 2014 with a deadline for comments of 30 July 2014....
by chuck_ltd | 23 Jan, 2014 | NIS
Please note that the EMA’s “Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period” were updated on the 17 October 2013 and published on the 11 November 2013. [read...
by chuck_ltd | 23 Jan, 2014 | NIS
On the 8 January 2014, the EMA published Revision 2 of the “Guideline on Good Pharmacovigilance Practices (GVP)” The revisions to Annex I – Definitions (EMA/876333/2011 Rev 2) of the GVP Guidelines includes the following: Addition of definitions...
by chuck_ltd | 18 Jan, 2014 | NIS
Audio-Visual Recording of Informed Consent There has been much talk over the past 6+ months about the new requirements for the patient consent process to be videoed. These requirements were implemented in late 2013 through the DCGI Administration Order of 19 Nov 2013....
by chuck_ltd | 18 Jan, 2014 | NIS
Transparency of payments and transfers of value Medicines Australia is a strong advocate for transparency of payments and other ‘transfers of value’ provided by the Australian medicines industry to health consumer organisations and healthcare professionals. The...
by chuck_ltd | 18 Jan, 2014 | NIS
Healthcare Professional Consultant Reports What are Healthcare Consumer Professional Consultants? The Code of Conduct defines a healthcare professional consultant as a healthcare professional who is engaged by a member company to provide services or advice for a fee,...
by chuck_ltd | 18 Jan, 2014 | NIS
The Privacy Amendment (Enhancing Privacy Protection) Act 2012 (Privacy Amendment Act) was introduced to Parliament on 23 May 2012 and was passed with amendments on 29 November 2012. The Privacy Amendment Act is a part of the privacy law reform process that began in...
by chuck_ltd | 18 Jan, 2014 | News, NIS
Author: Mark Heinemann, Senior NIS Submissions Specialist, inVentiv Health Clinical According to the provisions of article L.1453-1 CSP, pharmaceutical companies must now disclose the existence of agreements that they concluded with: Healthcare professionals,...
by chuck_ltd | 18 Jan, 2014 | CHCUK News & Articles, News, NIS
The federal law on human research clarifies the requirements of the Act in relation to the ethical, scientific and legal requirements that must be observed in research on humans. Here, the legal and administrative requirements depend on the extent of the risk to...
