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 | 21 Aug, 2019 | EMA, Real Word Evidence, Real World Research Design, Regulatory Grade RWE
Source: Cave, A. , Kurz, X. and Arlett, P. (2019), Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe. Clin. Pharmacol. Ther., 106: 36-39. doi:10.1002/cpt.1426 Real-world data (RWD) offers the possibility to derive novel...
by Syneos Health_1 | 18 Jul, 2019 | Consultation, Real Word Evidence, RWD
Summary NICE welcomes the opportunity to continue our well-established practice of translating evidence into practical guidance and advice, and to expand our methods and processes to enable more extensive and effective use of broader sources of data. We acknowledge...
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 | 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 Syneos Health_1 | 10 May, 2019 | 21 Century Cures Act, Consultation, Cures Act, FDA Guidance, Real Word Evidence, Regulatory Grade RWE
This draft FDA guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. FDA...
by Syneos Health_1 | 8 May, 2019 | Cures Act, Real Word Evidence, Real World Research Design, Regulatory Grade RWE, White Paper
In contrast to clinical development, in which the randomized controlled trial (RCT) is the go-to study design, real-world research encompasses a broader array of designs from which to choose. There are retrospective approaches, including database analysis and manual...
by Syneos Health_1 | 8 May, 2019 | Consultation, FDA Guidance, Rare Diseases, Real Word Evidence
The FDA has published a draft guidance for industry entitled “Rare Diseases: Common Issues in Drug Development.” The purpose of this draft guidance (January 2019) is to assist sponsors of drug and biological products for the treatment or prevention of rare diseases in...
by Syneos Health_1 | 8 May, 2019 | 21 Century Cures Act, HTA, Real Word Evidence, Registry
REQueST® tool and its Vision paper are now available for Public Consultation The use of registries is becoming increasingly common in health technology assessment (HTA) and regulation. There is a growing interest in the role of observational data in complementing...
by Syneos Health_1 | 9 Dec, 2018 | 21 Century Cures Act, FDA Guidance, Pragmatic Trials, Real Word Evidence, Registry, Regulatory Grade RWE
It’s here! The long awaited FDA “draft framework for implementation” of the real world evidence program required by Section 3022 of The 21st Century Cures Act (Cures Act) has been published. Framework for FDA’s Real World Evidence Program The Cures Act is...
by Syneos Health_1 | 9 Dec, 2018 | 21 Century Cures Act, Cures Act, FDA Guidance, Real Word Evidence
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them. Among other provisions, the Cures Act...
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 | 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 | 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 | 30 Mar, 2018 | 21 Century Cures Act, Cures Act, EHR, Real Word Evidence, Virtual Clinical Research
The Trump Administration is launching the MyHealthEData initiative which aims to empower patients by ensuring that they control their healthcare data and can decide how their data is going to be used, all while keeping that information safe and secure CMS is committed...
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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, GVP, Pragmatic Trials, Real Word Evidence, Registry, Virtual Clinical Research
Summary The European Medicines Agency is consulting stakeholders on an amended risk management plan (RMP) template, to be used by medicine developers. The revision of the template is based on the principles described in the updated good pharmacovigilance practices...
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 | 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 | 15 Jan, 2016 | CHCUK News & Articles, GCP, News, Pragmatic Trials, Real Word Evidence
Ministry of Health of Ukraine Amends the Procedure for Conducting Clinical Trials of Medicinal Products On December 31, 2015 the changes to the Ministry of Health’s Order No. 690, establishing the Procedure for Conducting Clinical Trials of Medicinal Products (the...
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, GCP, News, Pragmatic Trials, Real Word Evidence
Transcelerate Common Protocol Template The resources have been made available to enable use of a streamlined model protocol template with common structure and language. The Common Protocol Template contains sections marked as common text or text that may be used...
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...
