by Syneos Health_1 | 25 Jun, 2019 | EU Clinical Trials Regulation, GDPR, Uncategorized
The European Commission Directorate General for Health has published a question and answer document that aims to explain the interplay between the Clinical Trials Regulation (EU) 536/2014 and the General Data Protection Regulation (EU) 2016/679. This document “will be...
by chuck_ltd | 12 Feb, 2017 | 21 Century Cures Act, Consultation, FDAMA114, Uncategorized
18 January 2017 – the FDA released two separate draft guidances that will each help provide clarity for medical product companies, as well as other interested parties, on FDA’s current thinking and recommendations for a few different types of communications...
by chuck_ltd | 12 Jan, 2017 | Uncategorized
Source: Christopher M. Achatz, Associate, Bryan Cave LLP De-identification of data refers to the process used to prevent personal identifiers from being connected with information. The FTC indicated in its 2012 report Protecting Consumer Privacy in an Era of Rapid...
by chuck_ltd | 15 Apr, 2016 | Uncategorized
The Italian Supreme Administrative Court has just released an articulated judgment (n. 1306 of April 1, 2016) focused on the notion of “therapeutic equivalence” of pharmaceutical products, a concept which, as specified by the administrative judge, is conceptually and...
by chuck_ltd | 19 Nov, 2015 | Uncategorized
Source: http://pharmaviews.eu/donate-your-data/ Today is Organ Donation Day. Millions of European citizens have signed up to allow their organs to be used for transplantation after they die. My friend Miklós Szócska, former health minister of Hungary, suggested we...
by chuck_ltd | 18 Nov, 2015 | Uncategorized
Introduction The Stockholm Administrative Court of Appeal recently considered whether financial aspects can be assessed when determining whether there are special requirements for granting a named patient permission. The court dismissed arguments that high prices and...
by chuck_ltd | 9 Oct, 2015 | Uncategorized
There are 30 million Americans living with what S. 139 calls “rare diseases or conditions.” It is difficult enough facing such disorders, but it can be even more difficult finding those willing to participate in clinical trials to provide information, treat and...
by chuck_ltd | 28 Sep, 2015 | Uncategorized
Acknowledgement: Prof David Hutchinson; www.canarybooks.com On 7 August 2015, the Saudi Food and Drug Authority (SFDA) issued ‘Regulations & Requirements for Conducting Clinical Trials on Drugs’. The guidance – which takes immediate effect – notes that all...
by chuck_ltd | 2 Sep, 2015 | Uncategorized
The European Medicines Agency (EMA) is responsible for monitoring a number of substances and selected medical literature to identify suspected adverse reactions with medicines authorised in the European Union, and for entering the relevant information into the...
by chuck_ltd | 31 Aug, 2015 | Uncategorized
The movement to shift informed consent in clinical trials from paper forms to electronic devices has notched up another victory. Mytrus and an unnamed top-10 pharma company made the advance by becoming the first organizations to win clearance to use e-consent in a...
by chuck_ltd | 28 Aug, 2015 | Uncategorized
ClinRegs has updated its regulatory information for India to reflect changes described in the 5th and 6th Amendments to India’s Drugs and Cosmetics Rules, which took effect in summer 2015. Salient changes include: Initial investigator reporting timeline is now 24...
by chuck_ltd | 26 Aug, 2015 | Uncategorized
Next year about this time, the European Union will implement a new clinical trial regulation (EU CTR) meant to help pharmaceutical companies by offering clear and consistent rules for conducting clinical trials. The new regulation, EU CTR 536/2014, adopted last year...
by chuck_ltd | 11 Mar, 2015 | Uncategorized
Dr Ian Hudson, Chief Executive of Medicines and Healthcare Products Regulatory Agency, comments on the first scientific opinion granted in the UK. Chief Executive of the Medicines and Healthcare Products Regulatory Agency, Dr Ian Hudson said: “We are delighted...
by chuck_ltd | 11 Mar, 2015 | Uncategorized
eConsent Considerations in Europe Legal Framework for eSignatures The eSignature Directive (Directive 1999/93/EC) establishes the legal framework at European level for electronic signatures and certification services. The aim is to make electronic signatures easier...
by chuck_ltd | 11 Mar, 2015 | Uncategorized
Upon becoming a Non-Departmental Public Body (NDPB) on 1 January 2015, the HRA took responsibility for issuing guidance for research in England, in place of the Research Governance Framework (RGF). The HRA and Devolved Administrations committed to the ambition of...
by chuck_ltd | 26 Jan, 2015 | Uncategorized
ClinRegs is an online database of country-specific clinical research regulatory information designed to save time and effort in planning and implementing clinical research. With the publication of Sponsorship, Informed Consent, Investigational Products, and Specimens...
by chuck_ltd | 28 Nov, 2014 | Uncategorized
Research involving human subjects must undergo a medical ethics as it falls under the Law Medical Research with people (WMO). In addition, there are many forms of “non-WMO complicit” research with people that needs to be reviewed. How do we guarantee the...
by chuck_ltd | 13 Nov, 2014 | Uncategorized
The NIAID ClinRegs website provides an online database of country-specific clinical research regulatory information designed to enable users to explore regulations within a country and compare requirements across countries. By providing well-documented, up-to-date...
by chuck_ltd | 3 Nov, 2014 | Uncategorized
The long awaited revision of EMA GVP Module VI (Management and reporting of adverse reactions to medicinal products) has been released and became effective on 16-SEP-2014. Revisions include: Revisions in VI.A.2.1.1. (Causality), VI.A.2.4. (Seriousness), VI.B.1.2....
by chuck_ltd | 1 Sep, 2014 | Uncategorized
The National Monitoring Centre on Clinical Research with Medicines [Acknowledgements: Prof David Hutchinson. Principal Author & Editor of Advisor] [NOTE – The following does NOT apply to observational studies] The National Monitoring Centre on Clinical...
by chuck_ltd | 24 Aug, 2014 | Uncategorized
Cooperation among the best health professionals / institutions and pharmaceutical companies is an integral part of the healthcare system. As such, it has a positive impact on the quality of care and value for future medical research. Experts have valuable knowledge...
by chuck_ltd | 20 Aug, 2014 | Uncategorized
The Disclosure Code has been approved by the General Assembly on 24 June 2013. The final edited versions of the Code has been submitted to Compliance Committee comments, and has been reviewed by legal counsel. Watch the EFPIA Disclosure Code Video [Read More…]...
by chuck_ltd | 14 Aug, 2014 | Uncategorized
The website of the National Research Ethics Service (NRES) site will be closing in a few weeks. The only areas that are maintained are the directory of Research Ethics Committees and the Research Summaries. The information previously found on the NRES website can now...
by chuck_ltd | 14 Aug, 2014 | Uncategorized
The HRA is currently working on the development of a replacement for the Research Governance Framework. We will consult on when we are established as a Non-Departmental Public Body (as part of the enacting of the Care Bill [2012]). Research Governance Frameworks...
by chuck_ltd | 14 Aug, 2014 | Uncategorized
NHS REC Booking & Submission Changes – Implemented 19 May 2014 The HRA has changed the processes for applying to Research Ethics Committees (RECs) to improve its service and make the booking and application process more straightforward for researchers. The key...
by chuck_ltd | 15 Jul, 2014 | Uncategorized
The Guide on Methodological Standards in Pharmacoepidemiology offers a single web resource for methodological English language guidance in pharmacoepidemiology. For each topic covered, direct electronic access is given to internationally agreed recommendations, and...
by chuck_ltd | 1 Jul, 2014 | Uncategorized
On 1 July 2014, the Irish Medicines Board (IMB) changed its name to the Health Products Regulatory Authority (HPRA). Established in 1996, the IMB name has served us well. However, over the last 18 years our regulatory remit has expanded to include other health...
by chuck_ltd | 1 Jul, 2014 | Uncategorized
HRA Approval On 31 March 2014, Earl Howe, Parliamentary Under-Secretary of State for Quality, announced funding for the HRA Approval (full details in the press release). What is HRA Approval? HRA Approval will provide a single approval for research in the NHS...
by chuck_ltd | 1 Jul, 2014 | Uncategorized
On 27 May 2014, the Clinical Trials Regulation was published in the Official Journal of the EU (OJEU). The regulation, which will replace the existing EU Clinical Trials Directive, will streamline the authorisation process and harmonise requirements for clinical...
by chuck_ltd | 30 Apr, 2014 | Uncategorized
Revision 1 of EMA GVP Module V on risk management system was published on 25 April 2014, mainly to amend the requirements of part VI of the RMP as published already in the updated RMP templates, to introduce amendments in line with the new requirements for variation...
by chuck_ltd | 5 Apr, 2014 | Uncategorized
Both the elearning module and the detailed country-specific report for the Australian NIS considerations have been updated. So what’s changed? Medicines Australia Code of Conduct Guidelines Updated in Feb 2014 The Code of Conduct Guidelines now reflect and provide...
by chuck_ltd | 23 Mar, 2014 | Uncategorized
Both the elearning module and the detailed country-specific report for the NIS considerations have been updated. So what’s changed? Updated Pharmacovigilance Legislation Decree No 2012-1244 of November 8, 2012 relating to the strengthening of the safety...
by chuck_ltd | 17 Mar, 2014 | Uncategorized
EU pharmacovigilance legislation has recently undergone a major review that led to the adoption of new legislation in 2010, namely Directive 2010/84/EU and Regulation (EU) No 1235/2010. While the main focus of pharmacovigilance is the safety of the medicinal product,...
by chuck_ltd | 10 Mar, 2014 | Uncategorized
On 14 February 2014, Rossiyskaya Gazeta, the official edition of the Russian Government, published Order No. 300n of the Russian Ministry of Healthcare dated 16 May 2013 “On approving the requirements for healthcare organisations which conduct clinical trials of...
by chuck_ltd | 13 Feb, 2014 | Uncategorized
The Italian Medicines Agency has published an online update on new methods to be implemented for the management of Italian reports of suspected adverse reactions in which no information is available on the structure of membership of the warning. The new rules...
by chuck_ltd | 11 Jan, 2014 | Uncategorized
CHCUK has created a new app to help you to keep instantly up to date with what’s new in the world of non-interventional studies (NIS). The app is free to download and is available for Android, Blackberry, iPhones and Windows phones. You can download the app...
by chuck_ltd | 10 Jan, 2014 | Uncategorized
Transparency The industry recognises that transparency is an important means of building and maintaining confidence. The operation of the Code, including the complaints procedure, is a demonstration of the industry’s commitment to transparency as are the requirement...