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 | 13 Aug, 2019 | EFPIA, NIS, Professional Standards, Promotion and Advertising
In June 2019, the European Federation of Pharmaceutical Industries and Associations (EFPIA) consolidated its three EFPIA Codes (HCP – PO – Disclosure) into one simplified Code. Member Associations are asked to transpose the revised Code provisions by 30...
by Syneos Health_1 | 28 May, 2019 | Consultation, NIS, Real Word Evidence, Safety Management
ICH has released a new E series guideline for consultation: ICH E19 – Optimisation of Safety Data Collection Objective of the Guideline This Guideline is intended to provide internationally harmonised guidance on an optimised approach to safety data collection...
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 5 Aug, 2016 | CHCUK News & Articles, HTA, NIS, Pragmatic Trials, Real Word Evidence
The ‘Real world evidence’ workshop was held on 17 September 2015 as part of the Academy’s FORUM programme. It brought together participants from across industry, regulatory, academia and policy to explore the acceptability of real world evidence in regulatory and...
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 | 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...
by chuck_ltd | 15 Feb, 2016 | CHCUK News & Articles, EHR, News, NIS
Health secretary Jeremy Hunt announced earlier this week that more than £4 billion will be invested to bring modern technology into the NHS. It is thought that £1.8bn will be set aside to digitise records, removing the reliance on paper and outdated technology such as...
by chuck_ltd | 8 Feb, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, Reimbursement
February 2016 is expected to see the launch of a single market of medicines in the framework of the Eurasian Economic Union, which may be a game changer in the industry. Currently over 30 draft acts have been adopted, establishing EEU rules and principles for movement...
by chuck_ltd | 26 Jan, 2016 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Registry, Virtual Clinical Research
Starting from January 1st 2016 the online-platform BASEC (Buisness Administration System for Ethics Committees) to submit research project to Swiss Ethics Committees is mandatory. Link: https://submissions.swissethics.ch/en/ No submissions or updates outside of BASEC...
by chuck_ltd | 24 Dec, 2015 | CHCUK News & Articles, News, NIS, Professional Standards
The National Institute for Health and Care Excellence (NICE) has published a new guideline that aims to reduce the rate of premature births in the UK. Each year, 60,000 babies are born prematurely in the UK. Sadly, the reality is that some of these babies will not...
by chuck_ltd | 24 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Professional Standards, Real Word Evidence, Registry, Virtual Clinical Research
On 17 December 2015, the French National Assembly adopted a law on modernisation of the French health system (the “Public Health Law”). Key provisions will bring changes to how the pharmaceutical and medical device industries interact with HCPs, by...
by chuck_ltd | 21 Dec, 2015 | CHCUK News & Articles, EU Clinical Trials Regulation, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry
EMA Public Consultation on – ‘Points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations’ Start of public consultation: 21 December 2015 Deadline for comments: 31 May 2016 Provide comments using...
by chuck_ltd | 18 Dec, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry
The conduct of pharmacoepidemiology studies are regulated by pharmacovigilance legislation which varies by region and country throughout the globe. These regulations and resulting definitions and requirements are summarised in guidance documents for study sponsors and...
by chuck_ltd | 18 Dec, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry
New ENCePP Guidance on Conducting Systematic Reviews and Meta-Analyses of Completed Comparative Pharmacoepidemiological Studies of Safety Outcomes Annex 1 to the ENCePP Guide on Methodological Standards in Pharmacoepidemiology was adopted by the ENCePP Steering Group...
by chuck_ltd | 17 Dec, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence, Registry
Introduction The fight against corruption is a serious challenge in the pharmaceutical sector in Turkey and worldwide. This is because the state is generally the main buyer of goods and services provided by pharmaceutical companies and healthcare professionals such as...
by chuck_ltd | 16 Dec, 2015 | CHCUK News & Articles, Consultation, GVP, News, NIS, Real Word Evidence, Registry, Virtual Clinical Research
Latest EMA GVP (XVI) Module Update The final Addendum I to Module XVI on educational materials is published, taking into account comments from the public consultation. Further, revision 1 of Module XV on safety communication, with revision 1 of the template for Direct...
by chuck_ltd | 14 Dec, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry, Virtual Clinical Research
Human Rights Day – 10 October Herbert Smith Freehills LLP – Stéphane Brabant Beyond the traditional judicial fora where business enterprises can be challenged for human rights violations, they now also face ‘new judges’ such as NGOs, consumers, financial...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, Consultation, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Registry
Revision of CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects In 2010 the Executive Committee of CIOMS decided to revise the CIOMS Ethical Guidelines for Biomedical Research. The document was last revised in 2002. Since then,...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, HTA, News, NIS, Real Word Evidence, Registry
New EUnetHTA joint action, co-financed by the EC and participating bodies from nearly all EU Member States, is due to start in early 2016. One of the work packages will be dedicated to evidence generation, dealing with the question of early dialogue on initial data...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, News, NIS, Real Word Evidence
Lessons Learned from PROTECT on Common Protocols for Multi-Database Studies Insights into common protocol studies – including a list of recommendations – which were conducted in the framework of the PROTECT project. Presented by: Olaf Klungel, Utrecht...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence, Registry
Introducing the Observatoire Français de la Sclérose en Plaques (OFSEP), a registry whose objective it is to maintain and expand the cohort of patients with MS in France, to enrich existing clinical data with imaging and medical-economic data and with biological...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence
Why are Academics Not Keen on Pharma Funding? Less (or no) kudos for industry studies Study design often ‘fixed’ Usually ‘sponsored’ by industry Institution keeps all the money Study question of limited interest Good publications ‘difficult’ Opportunity cost; less...
by chuck_ltd | 12 Dec, 2015 | CHCUK News & Articles, Consultation, GCP, News, NIS, Pragmatic Trials, Real Word Evidence
Introduction (Highlights from the ENCePP Plenary Meeting, 24 November 2015) Xavier Kurz set the scene by presenting a brief introduction highlighting ENCePP’s potential role and contribution so far to the regulatory need for continuous monitoring and investigation of...
by chuck_ltd | 11 Dec, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Real Word Evidence
Non-interventional studies (NIS) are a key tool for collecting information about how a drug is actually used (+ safety, effectiveness, healthcare benefit and value etc…) once it’s been approved (e.g., by FDA in the USA) and accepted for reimbursement...
by chuck_ltd | 11 Dec, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Real Word Evidence, Virtual Clinical Research
On 16 October 2015, CMS hosted a conference on the implications of the European Commission’s plans to create a Digital Single Market. The conference generated meaningful discussions on the true impact, reality and consequences of the proposed framework. Key figures...
by chuck_ltd | 8 Dec, 2015 | CHCUK News & Articles, Data Privacy, EHR, GCP, Medical Apps, News, NIS, Real Word Evidence, Virtual Clinical Research
Commission Welcomes Agreement to Make EU Online Environment More Secure European Commission – Press release Brussels, 8 December 2015 Negotiators of the European Parliament, the Council and the Commission have agreed on the first EU-wide legislation on...
by chuck_ltd | 8 Dec, 2015 | CHCUK News & Articles, Data Privacy, News, NIS, Real Word Evidence
The revised Health Information and Patient Safety Bill, as drafted, will grant certain researchers the ability to obtain personal data without the consent of the relevant individual. The Bill envisages that the Data Protection Commissioner will have a role in...
by chuck_ltd | 7 Dec, 2015 | CHCUK News & Articles, Data Privacy, EHR, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
NHS trusts and health boards sponsoring a clinical trial, or hosting a trial sponsored by a commercial company need to ensure their electronic health record systems comply with legal requirements for good clinical practice. This guidance covers common inspection...
by chuck_ltd | 4 Dec, 2015 | CHCUK News & Articles, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
Industry-changing technology will help break down healthcare and clinical research silos, empowering organizations to connect and share verifiable information in real time. Texas-based healthcare and clinical research networking-technology company HealthCarePoint...
by chuck_ltd | 1 Dec, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence
Background: The Danish National Patient Registry (DNPR) is one of the world’s oldest nationwide hospital registries and is used extensively for research. Many studies have validated algorithms for identifying health events in the DNPR, but the reports are...
by chuck_ltd | 1 Dec, 2015 | CHCUK News & Articles, EHR, GCP, News, NIS, Pragmatic Trials, Real Word Evidence, Virtual Clinical Research
Background A national Electronic Health Record (EHR) has been identified by HSE National Directors and clinical leaders as a key capability requirement for the future delivery of healthcare. While technology solutions are a key component, there will be a primary focus...
by chuck_ltd | 27 Nov, 2015 | CHCUK News & Articles, News, NIS, Pragmatic Trials, Real Word Evidence
Global, regional, and national disability-adjusted life years (DALYs) for 306 diseases and injuries and healthy life expectancy (HALE) for 188 countries, 1990–2013: quantifying the epidemiological transition Lancet: Volume 386, No. 10009, p2145–2191, 28 November 2015...
by chuck_ltd | 26 Nov, 2015 | CHCUK News & Articles, HTA, News, NIS, Pragmatic Trials, Real Word Evidence
Observational (OBS), Pragmatic (PRA), and Indirect (IND) Methodologies for Comparative / Relative Effectiveness (RE) and Benefit-Risk (BR) Analyses Dr Florian Eichmann, Kathrin Kreyenberg – Late Stage Business Unit, inVentiv Health Clinical, Munich, Germany...
