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 Syneos Health_1 | 23 Aug, 2019 | CHCUK News & Articles
CMS Cameron McKenna Nabarro Olswang LLP – Valentina Parvu On 17 July 2019, law no. 134/2019 ((“Law 134”) on the reorganization of the National Agency for Medicine and Medical Devices (“ANMDM”) was published in the Official Gazette. The changes brought by Law 134...
by Syneos Health_1 | 20 Aug, 2019 | CHCUK News & Articles, FDA 1572
Question: Do researchers involved in conducting clinical trials in the Republic of Slovenia have to sign FDA Form 1572 at the request of the sponsor? Answer: No. Rationale: Researchers signing FDA Form 1572 confirm that they will conduct a clinical trial of a drug in...
by Syneos Health_1 | 30 May, 2019 | CHCUK News & Articles, Consultation, Real Word Evidence, Real World Research Design, Regulatory Grade RWE
May 2019 – the Center for Drug Evaluation (China) has released a draft document for public review on “Key Considerations in Using Real-World Evidence to Support Drug Development” Background and Purpose Randomized Controlled Trials (RCTs) are...
by Syneos Health_1 | 19 Nov, 2018 | 21 Century Cures Act, CHCUK News & Articles, Consultation, Real Word Evidence, Registry, Regulatory Grade RWE
Use of patient disease registries for regulatory purposes (new) On 8 November 2018 the EMA cross-committee task force published a discussion paper on methodological and operational considerations in the use of patient disease registries for regulatory purposes:...
by Syneos Health_1 | 19 Nov, 2018 | Brexit, CHCUK News & Articles, Data Privacy, Digital Health Technology, eConsent, eletronic Signatures
MHRA/HRA Joint statement on seeking eConsent – A joint MHRA/HRA statement (eConsent Statement) has been published which sets out the legal and ethical requirements for seeking and documenting consent using electronic methods. It has become apparent that eConsent...
by Syneos Health_1 | 19 Nov, 2018 | CHCUK News & Articles, Digital Health Technology, Real Word Evidence
Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulation Source: Pacurariu A, Plueschke K, McGettigan P, et al. Electronic healthcare databases in Europe: descriptive analysis of characteristics...
by chuck_ltd | 22 Aug, 2018 | CHCUK News & Articles, Data Privacy, Informed Consent, NIS
France – Health Research and Data Protection: Lawmakers Revise Research Standard MR-003 “Research in the Field of Health Without Collection of Consent” By Mark Heinemann, Principal Consultant, Real World Clinical Consulting, Syneos Health The French Data Protection...
by chuck_ltd | 15 Apr, 2018 | CHCUK News & Articles, Data Privacy, Digital Health Technology, eConsent
While the shift to digital technologies is pervasive across multiple industries, the informed consent process for clinical trials has been historically paper-based. Given the inefficiencies in the traditional process and the increasing complexity of clinical studies,...
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 | 29 Mar, 2018 | Biosamples, CHCUK News & Articles, Human Tissue Research
The Brazil profile in ClinRegs has been reviewed and updated to reflect the implementation of RDC No. 172 of 8 September 2017. This resolution states that ANVISA will analyze imported human biological samples and goods and products intended for use in human subject...
by chuck_ltd | 24 Mar, 2018 | CHCUK News & Articles, Digital Health Technology, FDA Guidance
This DRAFT guidance addresses how to comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the “combination product PMSR final rule,”...
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 | 29 Aug, 2017 | CHCUK News & Articles, PASS
GVP Module VI, which deals with the collection, management and submission of reports of suspected adverse reactions to medicinal products has been amended. Revision 2 comes into effect on the 22 November 2017. Revision 2 boasts 144 pages versus the 90 pages of...
by chuck_ltd | 27 Jul, 2017 | 21 Century Cures Act, CHCUK News & Articles, Pragmatic Trials, Real Word Evidence
FDA issues guidance for immediate implementation- IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects Author: Patricia Garcia, Regulatory Consultant, Late Stage, Clinical Division, Inventiv...
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 | 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 | 7 Mar, 2017 | CHCUK News & Articles, EAP, Orphan Drugs, Rare Diseases, Real Word Evidence
PRIME (PRIority MEdicines) is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of...
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 | 3 Mar, 2017 | CHCUK News & Articles, NIS, NIS Considerations Report
Author: Mark Heinemann, Princpal Regulatory Consultant, RWE and Insights, inVentiv Health An important modification of the French research law framework occurred in November 2016 with the coming into force of decree No. 2016-1537. The law describes the modalities for...
by chuck_ltd | 14 Feb, 2017 | CHCUK News & Articles, Safety Management
The Ministry of Food and Drug Safety of Korea (the “MFDS”) announced major policy initiatives in the pharmaceutical sector for 2017 on January 9, 2017 (the “Policy Initiative”) With respect to pharmaceuticals, the MFDS declared plans to select...
by chuck_ltd | 14 Feb, 2017 | CHCUK News & Articles, Market Access, Promotion and Advertising
Rules that govern advertising and promotion activities of medicines and medical devices in Portugal have been changed recently by the enactment of Decree-Law 5/2017 of 6 January (“Decree-Law 5/2017”). This new legal act establishes principles that shall be...
by chuck_ltd | 30 Jan, 2017 | CHCUK News & Articles, Sunshine Regulations, Transparency
The long-awaited decree that clarifies the French “Sunshine” obligations was recently published in the French Official Gazette, and it brings about some important changes to the existing transparency requirements that apply in the life sciences sector in...
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 | 6 Jan, 2017 | CHCUK News & Articles, Digital Health Technology
Largely overlooked in the 900+ page 21st Century Cures Act (the “Cures Act”) signed into law on December 13, 2016, was a directive from Congress for further study into the use of technology for the delivery of health care services. A second bill signed into law the...
by chuck_ltd | 6 Jan, 2017 | Biosimilars, CHCUK News & Articles
Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes and 16 biosimilar applications, including...
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 | 21 Nov, 2016 | CHCUK News & Articles, Digital Health Technology, Medical Apps
‘In 2016 users will trust health apps more than their doctors’. So predicted Forbes Magazine in 2015 in reference to Mobile Health (“mHealth”) apps, which are becoming increasingly popular to monitor health and well-being. However, the rapid...
by chuck_ltd | 14 Nov, 2016 | AI, CHCUK News & Articles, Digital Health Technology
Last month, three life sciences giants announced new or deepening partnerships with IBM, to capitalise on IBM’s supercomputer, ‘Watson’, an artificially intelligent computer system. There has been a lot of buzz recently about how big data can be meaningfully applied...
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...