Pharmaceuticals – Page 8
-
JournalIs consulting in regulatory affairs your next career path?
Navigating the corporate ladder isn’t always clear cut. Along the way you may move in and out of the industry, stay in one position for too long, or even jump from specialist to director. Some ditch the politics all together and become their own boss. What is it like being a consultant, contingent worker, or contractor?
-
JournalEnvironmental impact of pharmaceuticals and regulation in the EU
The profound impact of pharmaceuticals on the environment has been acknowledged for decades. In the EU, two key mechanisms that assess this risk are the Environmental Risk Assessment (ERA), and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As both frameworks are under assessment, this article looks at the key considerations within the ERA.
-
JournalAccelerated regulatory pathways: Vaccines for tropical diseases
Reproduced from an online seminar presentation, made in collaboration with TOPRA and hVIVO, given on 21 June 2022 by Bruno Speder from hVIVO.
-
JournalPatient information — why do things go wrong?
Are common root causes leading to the pharmaceutical industry being non-compliant with the legal obligation to keep authorised product information up to date?
-
JournalA View of…The Environmental Impact of Pharmaceuticals
The body of research being published which is focused on the environmental impact of pharmaceuticals is increasing rapidly. It highlights a growing concern among the public for medicinal products accumulating in the natural world through a variety of originating sources.
-
JournalAn integrated approach to collecting patient experience data: An industry perspective
Patient experience data (PED) are intended to provide information about patients’ experiences with a disease or condition. There is growing interest from multiple stakeholders, including pharmaceutical companies to collect PED to inform the development and commercialisation of new drugs. Present efforts to generate PED ofen result in disjointed, overlapping, or duplicated efforts within and between pharmaceutical companies.
-
JournalConsiderations for sponsors when producing an EU IMPD: Impact of the EU-CTR
European Union (EU) pharmaceutical legislation – known as the Clinical Trial Regulation (EU-CTR), came into effect on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a wider scale, with high standards of public transparency and safety for clinical trial participants.
-
JournalEuropean regulatory fees – complexity, concerns and solutions for efficiency
Regulatory authorities charge fees for the services they provide related to marketing authorisations. This research aimed to understand the complexity and concerns around the fee calculation and payment process for EU procedures used for market approval of a drug and proposes potential solutions to improve efficiency.
-
![AdobeStock_424041822 (1) [Converted]](https://ds982gbwnvyso.cloudfront.net/Pictures/100x67/3/4/5/345_adobestock_4240418221converted_918379.png)
JournalBreakthrough therapy designation: From serious diseases to opioid crisis prevention
Following the human immunodeficiency virus crisis of the 1980s, the US Congress and US Food and Drug Administration (FDA) introduced several regulatory initiatives. The purpose was to expedite FDA review and approval of products to overcome the longer traditional pathway review timelines. One such process enabling faster approval is the ...
-
-
JournalThe worldwide acceptance of non-legalised eCPPs
The transition from paper-based format to electronic Certificates of Pharmaceutical Product (eCPPs) has seen an increased uptake as a result of the operational limitations associated with the COVID-19 pandemic. While issuing regulatory agencies (RA), such the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) now offer ...
-
JournalUS FDA CDER and CBER guidance of interest
The US Food and Drug Administration (FDA) has been steadily increasing the number of guidance documents produced on a yearly basis over the past decade. However, even with this increased pace, there are numerous topics that industry is looking to the FDA for clarity, especially newer topics like gene therapy, ...
-
JournalThe health economics profile of new pharmaceuticals
The current article discusses elements of the health economics profile of new pharmaceuticals, specifically looking at the challenges of providing a healthcare system, the concepts around the provision of value-based healthcare systems and calculating the cost-effectiveness of new medicines. A quality-adjusted life year (QALY) is a concept used in health ...
-
-
-
JournalHarmonising regulation of medicinal allergen products throughout the European Union – the historic situation and subsequent CMDh guidance
Allergen products in the EU are defined as goods ‘intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent’. Historically, allergens were authorised under the national frameworks of member states (MS) with some legislation pre-dating the Treaty of Rome in 1957. This led to regulatory problems, such as pharmacovigilance monitoring standards. The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) addressed these authorisation issues and published a document on recommendations to common regulatory approaches for medicinal allergen products. This article provides an overview of the CMDh guidance, including a summary of some of the responses received during its consultation phase.
-
FocusHow data remediation and stewardship is becoming a standard responsibility for regulatory operations professionals
Data quality is becoming increasingly critical to the success of medicinal product applications and has the potential to increase the speed and efficiency of medicines supply to patients. There is an industry move towards a data-driven regulatory enterprise, highlighted particularly through the arrival of initiatives such as identification of medicinal products (IDMP), real world evidence (RWE), digital application dataset integration (DADI), electronic product information (ePI), marketing status (IRIS), US FDA knowledge-aided assessment and structured application (KASA) and eCTD 4.0, among others.
-
JournalEU reclassification (Rx to OTC switch) regulatory framework – what are the key challenges for industry and how might these be overcome? Part 2
Rx to over the counter (OTC) switch is the regulatory process that medicines must go through before they can be purchased in a pharmacy or general shop without a prescription. This research investigates the challenges the pharmaceutical industry has faced with this process in the European Union and proposes where improvements could be made. It is important for consumers to have direct access to medicines without a prescription as this allows time for doctors to focus on more urgent care needs. This emphasis on consumer ‘self-care’ is even more important now, during a pandemic, when face-to-face consultations with doctors have reduced.
-
JournalInclusion of older people in drug development and clinical trials: Part 1
As the global population ages, older people will increasingly become the main users of medication. Much work has already been done by regulatory authorities to review legislation, leading to the 2013 publication of the EMA’s Geriatric Medicines Strategy. It reported, however, that many clinical trials still did not include a representative number of older people – aged 65 and over – despite the drugs in development were most likely to be used by this cohort. This two-article series will analyse if the publication of ICH E7 Q&A influenced the number of older people included in clinical trials. Furthermore, a qualitative questionnaire assessed the extent to which clinical trials are designed to adequately represent older people. In part one, I will focus on the legislative framework governing drug development for older patients, and the sub-classifications of age groups.
-
JournalAntibiotics in biopharmaceutical production
As per the WHO, antimicrobial resistance (AMR) is a global health threat and a complex problem that requires a united multisectoral approach. In the interest of patients and environmental safety, regulators around the globe are discouraging the use of antibiotics in all areas of their utilisation ie, not only at ...