by Mark Heinemann | 6 Feb, 2020 | CHCUK News & Articles, Consultation, Data Privacy, News, NIS, PASS, Pragmatic Trials, Real Word Evidence, Registry, Regulatory Intelligence
2010 to 2019: BFARM / PEI Guidelines on Drug Observation Studies (AWB) and Voluntary Post-Authorization Safety Studies (PASS) Updated New recommendations of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute on observational drug...
by chuck_ltd | 9 Apr, 2018 | CHCUK News & Articles, News, NIS, PASS, Real Word Evidence, Registry
Germany – Professional Advice under Section 15 BO Ärzte: Speeding up the Process for Non-Interventional Studies? Author: Mark Heinemann, Principal Regulatory Advisor, CHCUK Consulting German Ethics Committees (ECs) make an important step towards the...
by chuck_ltd | 3 Nov, 2017 | CHCUK News & Articles, CHCUK NIS Database, News, NIS, NIS Considerations Report
Non-Interventional Studies… Q. What is the Biggest Challenge? A. Working out the regulatory requirements for your study! Finding out what’s needed to run a non-interventional study shouldn’t be difficult, but it is! We’ve taken the pain out of that process by...
by chuck_ltd | 22 Jul, 2017 | CHCUK News & Articles, News, NIS, PASS, Real Word Evidence, Real World Evidence
The recently updated EMA page lists questions that marketing-authorisation holders (MAHs) may have on post-authorisation safety studies (PASSs). It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in...
by chuck_ltd | 8 Jul, 2017 | CHCUK News & Articles, News, NIS, Real Word Evidence
The 6th revision of the ENCePP Methods Guide is now available on the ENCePP website and includes revisions, amendments and new references in all the chapters. Revisions were performed by the authors, in collaboration with the editorial group. External comments...
by chuck_ltd | 8 Jul, 2017 | EHR, eletronic Signatures, GCP, News
The FDA released a new draft guidance document on 21 June 2017. Comments should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. >>>Link to Draft Guidance Document: Use of...
by chuck_ltd | 6 Jul, 2017 | CHCUK News & Articles, Medical Apps, Medical Devices, News
Source: Osborne Clarke It is widely known that in some circumstances, software may fall within the category of medical device and so have to comply with the associated regulations as regards its marketing. But deciding exactly when software will be categorised as...
by chuck_ltd | 9 Mar, 2017 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry
What are the real-world evidence tools and how can they support decision making? EMA-EuropaBio Info Day – 22nd November 2016 Dr Alison Cave, Principal Scientific Administrator, Pharmacovigilance and Epidemiology Department, EMA [View Slide Deck…] RWE –...
by chuck_ltd | 3 Mar, 2017 | CHCUK News & Articles, News, NIS, NIS Considerations Report, Regulatory Intelligence
The German Bundestag adopts Fourth Act on the Amendment of the German Drug Act and Other Provisions Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health The 4th law on the amendment of the German Drug Act came into force on...
by chuck_ltd | 23 Jan, 2017 | CHCUK News & Articles, Consultation, GCP, News, NIS, Real Word Evidence
ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) “Renovation”, which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and...
by chuck_ltd | 20 Jan, 2017 | CHCUK News & Articles, HIPAA, News, NIS, Real Word Evidence
The U.S. Department of Health and Human Services and 15 other federal agencies today (19 January 2017) issued a final rule to update regulations that safeguard individuals who participate in research. Most provisions in the new rule will go into effect in 2018. The...
by chuck_ltd | 19 Jan, 2017 | CHCUK News & Articles, Cures Act, EAP, News
The landmark 21st Century Cures Act[1] (“Cures Act”), which was signed into law by President Obama and became effective on December 13, 2016 (“Enactment Date”), imposes a deadline by which the manufacturer or distributor of an investigational...
by chuck_ltd | 18 Jan, 2017 | Brexit, CHCUK News & Articles, Market Access, News
In October 2016, the National institute for Health and Care Excellence (NICE) and National Health Service England (NHS England) launched a 12 week consultation on proposed changes to the arrangements for evaluating and funding drugs and other health technologies...
by chuck_ltd | 13 Jan, 2017 | CHCUK News & Articles, News
On December 6, 2016 the U.S. Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued two final rules relating to the Anti-Kickback Statute (AKS) and Civil Monetary Penalties (CMP). These rules affect a wide variety of health care...
by chuck_ltd | 13 Jan, 2017 | CHCUK News & Articles, Data Privacy, HIPAA, News
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) has announced its first Health Insurance Portability and Accountability Act (HIPAA) settlement of the year regarding the untimely reporting of a breach of unsecured protected health...
by chuck_ltd | 12 Jan, 2017 | Brexit, CHCUK News & Articles, News
Source: Robert Breedon, partner at Gowling WLG and Head of the Health and Care Sector While concern undoubtedly persists across the board about the potential business implications of Britain leaving the EU, it appears that US health product manufacturers and providers...
by chuck_ltd | 12 Jan, 2017 | CHCUK News & Articles, News
On Dec. 13, President Obama signed into law the 21st Century Cures Act (Cures). The goal was to “accelerate the discovery, development and delivery” of innovative products, including by adding and modifying various programs administered by the Food and Drug...
by chuck_ltd | 11 Jan, 2017 | CHCUK News & Articles, News, Orphan Drugs, Rare Diseases
The EU’s regulatory framework for orphan drugs is set out in Regulation (EC) No.141/2000 (the “Orphan Drug Regulation”, or ODR) and implementing Regulation (EC) No. 847/2000, and has been in force for a while now with relatively few changes. However, in recent years,...
by chuck_ltd | 9 Jan, 2017 | CHCUK News & Articles, Cybersecurity, Digital Health Technology, Medical Apps, Medical Devices, News
On 28 December 2016, the Food and Drug Administration (FDA) issued guidance to inform industry and FDA staff of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices. In addition to the specific...
by chuck_ltd | 9 Jan, 2017 | CHCUK News & Articles, News
The International Compilation of Human Research Standards enumerates over 1,000 laws, regulations, and guidelines that govern human subjects research in 126 countries, as well as standards from a number of international and regional organizations. This Compilation was...
by chuck_ltd | 3 Jan, 2017 | CHCUK News & Articles, Data Privacy, News
The United States has traditionally taken a libertarian approach to data privacy: “what is not forbidden is permitted.” Outside sensitive sectors such as health (HIPAA) and finance (GLBA), the United States was historically content to let the market police itself. The...
by chuck_ltd | 1 Jan, 2017 | CHCUK News & Articles, Digital Health Technology, GCP, News, Virtual Clinical Research
Finalised FDA Guidance Published December 2016 This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This guidance is intended for...
by chuck_ltd | 22 Dec, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, News, Publication Guidelines
On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use...
by chuck_ltd | 22 Nov, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, News
Note – Amended text in RED Décret n° 2016-1537 du 16 novembre 2016: publication in the French Official Journal of a decree concerning research involving the human person Decree No. 2016-1537 of 16 November 2016, published in the Official Gazette of 17 November...
by chuck_ltd | 9 Nov, 2016 | CHCUK News & Articles, GCP, News
The National Institute of Allergy and Infectious Diseases (NIAID) announced that the ClinRegs website, which provides clinical regulations for countries around the world, has undergone several functionality upgrades to make the site easier to use. The updated site...
by chuck_ltd | 18 Oct, 2016 | CHCUK News & Articles, Data Privacy, News
Last week, the HHS Office of Civil Rights (OCR) released its long-awaited “Guidance on HIPAA & Cloud Computing” (Guidance). Using 11 questions and comprehensive responses, the Guidance details OCR’s position on the obligations of covered entities and business...
by chuck_ltd | 30 Sep, 2016 | CHCUK News & Articles, News, NIS
Guest Contributor – Mark Heinemann, Principal Regulatory Specialist, Late Stage, InVentiv Health Clinical The French Ministry of Research and Higher Education (MESR) informs in a recent update of its website...
by chuck_ltd | 30 Sep, 2016 | CHCUK News & Articles, News, Reimbursement
It is becoming more difficult to demonstrate that new treatments are cost efficient and should be included in the reimbursement scheme. A pharmaceutical company’s application to the Dental and Pharmaceutical Benefits Agency (TLV) for a pricing and reimbursement...
by chuck_ltd | 10 Sep, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, White Paper
White Paper – The Real-World Evidence Equation: Finding the Right Late-Stage Study Design Florian Eichmann, PhD, Principal, Scientific Affairs & Real World Evidence, Late Stage, inVentiv Health Clinical Stuart McCully, PhD, Vice President, Regulatory...
by chuck_ltd | 31 Aug, 2016 | CHCUK News & Articles, Medical Apps, Medical Devices, News, Real Word Evidence
Updated guidance issued to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe. From counting steps to helping healthcare professionals prescribe treatment for burns injuries, healthcare apps and...
by chuck_ltd | 30 Aug, 2016 | CHCUK News & Articles, Data Privacy, News
The European Commission has drafted a code of conduct on privacy for mobile health (mHealth) apps (the “Code”). The Code has been submitted to the Article 29 Data Protection Working Group for approval. The Code aims to provide a user friendly guide to compliance with...
by chuck_ltd | 17 Aug, 2016 | Biosimilars, CHCUK News & Articles, News
Guideline on Good Pharmacovigilance Practices (GVP). Product- or Population-Specific Considerations II: Biological Medicinal Products The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), entitled...
by chuck_ltd | 10 Aug, 2016 | CHCUK News & Articles, GVP, News, NIS, Real Word Evidence
Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 2) Date for coming into effect of Revision 2 – 9 August 2016 Revision 2 contains the following: Changes to VIII.A., clarifying the link between the...
by chuck_ltd | 10 Aug, 2016 | CHCUK News & Articles, GVP, News, NIS
European Commission publishes three-year report on implementation of pharmacovigilance legislation Closer collaboration between the European Medicines Agency (EMA), the European Commission and the EU Member States, enabled by the new European pharmacovigilance...
by chuck_ltd | 10 Aug, 2016 | CHCUK News & Articles, Consultation, GVP, News, NIS
Draft guideline on good pharmacovigilance practices (GVP) – Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2) This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC 183 and Chapter...
by chuck_ltd | 8 Aug, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence
Enhancing the Application of Real-World Evidence In Regulatory Decision-Making Washington Plaza Hotel • Washington, DC March 3 & 4, 2016 Event Details The last decade has seen important progress in the development of evidence from routine clinical practice,...
by chuck_ltd | 8 Aug, 2016 | CHCUK News & Articles, Medical Devices, News, Real Word Evidence
FDA has issued a draft guidance to clarify how they evaluate real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices....
by chuck_ltd | 16 Jun, 2016 | CHCUK News & Articles, News
Most men aged over 60 have some form of enlargement of the prostate gland and around 13,000 men in the UK are thought to have non-cancerous enlargement known as benign prostatic hypertrophy (BPH). This condition can make it difficult to pass urine as the swollen...
by chuck_ltd | 10 May, 2016 | CHCUK News & Articles, Data Privacy, News, Virtual Clinical Research
The EU Data Protection legislation has been reformed. On 15 December 2015, the European Parliament, the Council and the Commission reached agreement on the new data protection rules, establishing a modern and harmonised data protection framework across the EU. The...
by chuck_ltd | 9 May, 2016 | CHCUK News & Articles, News, NIS, PROs
The importance of the patient’s point of view on their health status is fully acknowledged and such information may be used in drawing regulatory conclusions regarding treatment effects, in the benefit risk balance assessment or as specific therapeutic claims in...
by chuck_ltd | 29 Apr, 2016 | Biosimilars, CHCUK News & Articles, News
Biosimilars, otherwise known as subsequent entry biologics or “SEBs” in Canada, are a rapidly emerging trend in healthcare. There is a common misconception that biosimilars are “generic” biologic medications. In reality, biosimilars and traditional generic...
by chuck_ltd | 18 Apr, 2016 | CHCUK News & Articles, GVP, News
Drug companies operating in Russia and other Eurasian Economic Union (“EAEU”) countries are being advised to prepare for the new obligations and liabilities that an impending new regulation on pharmacovigilance in the EAEU might introduce for them. The new...
by chuck_ltd | 14 Apr, 2016 | CHCUK News & Articles, News
The European Medicines Agency (EMA) has begun running a series of modular training courses to support stakeholders in using EudraVigilance, the centralized database for managing information on suspected adverse reactions reported with medicines authorised in the...
by chuck_ltd | 26 Mar, 2016 | CHCUK News & Articles, News
23 March 2016: Launch of the European iPSC Bank EBiSC, the European Bank for induced pluripotent Stem Cells announces the public launch of its on-line catalogue of induced Pluripotent Stem Cells (iPSCs) which are available to academic and commercial scientists for use...
by chuck_ltd | 24 Mar, 2016 | CHCUK News & Articles, HTA, News, Real Word Evidence, Reimbursement
Date: 16/02/2016 Purpose of the meeting DG SANTE was invited to the EFPIA Working Group on HTA. The purpose of the meeting was to present the EU activities on HTA and to discuss the possible ways of HTA collaboration in the area of relative efficacy (REA) in view of...
by chuck_ltd | 24 Mar, 2016 | CHCUK News & Articles, Digital Health Technology, HTA, News, Real Word Evidence
Kick-off meeting of the third HTA Joint Action: 3 March 2016 The kick-off meeting of “EUNetHTA 3” (2016-2019) – the third Joint Action which aims to pave the way for sustainable cooperation on Health Technology Assessment (HTA) in Europe takes place in Amsterdam...
by chuck_ltd | 16 Mar, 2016 | CHCUK News & Articles, Digital Health Technology, News, Patient Centricity, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
Davis, CA. – March 07, 2016 – Mytrus, a pioneer in innovative technologies for improving patients’ participation in clinical trials, has announced that its Enroll® and Engage™ technology infrastructure will support the ADAPTABLE (Aspirin Dosing: A...
by chuck_ltd | 1 Mar, 2016 | CHCUK News & Articles, Cybersecurity, Data Privacy, Digital Health Technology, Medical Apps, News, Virtual Clinical Research
Strasbourg, 2 February 2016 The European Commission and the United States have agreed on a new framework for transatlantic data flows: the EU-US Privacy Shield. Today, the College of Commissioners approved the political agreement reached and has mandated...
by chuck_ltd | 24 Feb, 2016 | CHCUK News & Articles, EU Clinical Trials Regulation, HTA, News, NIS, Pragmatic Trials, Real Word Evidence, Webinar
Regulators, Health Technology Assessment (HTA) agencies and health care payers are increasingly demanding Real World Evidence (RWE) to support both initial product approval/reimbursement as well as continuing approval/reimbursement over a product’s life cycle....
by chuck_ltd | 18 Feb, 2016 | News, NIS
Publication date: 17/02/2016 The Prescription Medicines Code of Practice Authority (PMCPA) is responsible for administering the ABPI Code of Practice for the pharmaceutical industry at arm’s length of the ABPI itself. The code regulates the advertising of...
