| (Published: Thu, 12 May 2022 15:27:57 +0000) |
| An Exclusive Webinar on Medical Devices in the UK & UKCA Certification Readiness |
| Europe is the busiest region with evolving Regulatory landscape, as Brexit compliance, application of the EU MDR, transition to UKCA marking, and upcoming IVDR deadline take the front seat. All these dynamics have kept the Regulatory professionals on their toes. The UKCA mark came into effect on Jan |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 06 May 2022 09:58:49 +0000) |
| Modernization of Food Regulations in Canada |
| This article talks about the Modernization of Health Canada’s Food Regulations to ensure safety and smooth market entry of products in Canada. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 06 May 2022 09:57:53 +0000) |
| Health Canada Labeling standards for Cosmetic products in Canada |
| This article talks about the Health Canada’s (HC) cosmetic labeling regulations and the importance of International Nomenclature of Cosmetic Ingredients (INCI) in Canada. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Fri, 06 May 2022 09:57:09 +0000) |
| Regulatory Publishing & Submission with Automation |
| This article talks about the transformation of regulatory publishing & submissions with automation to reduce the time and improve productivity. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 20 Apr 2022 12:45:17 +0000) |
| Data-driven Regulatory Intelligence System for Life science Companies |
| This article talks about the data-driven regulatory intelligence system for Life science companies to stay compliant with the new global Health Authority regulatory guidelines. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 20 Apr 2022 12:44:47 +0000) |
| FSSAIâs New Labeling & Display Regulations for Pre-packed Foods |
| This article talks about the FSSAI’s new labeling & display regulations for pre-packed foods.The Food Safety and Standards Authority of India (FSSAI) has divided the ‘Food Safety and Standards (Packaging and Labeling) Regulations, 2011’ into two (02) separate regulations: Food Safety and S |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 20 Apr 2022 12:43:45 +0000) |
| US FDA's cost-saving approach to the transition from CSV to CSA in 2022 |
| This article talks about the US FDA's cost-saving approach to the transition from Computer System Validation (CSV) to Computer Software Assurance (CSA) in 2022. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 20 Apr 2022 12:06:11 +0000) |
| HPRAâs Perspective on multilingual labeling |
| This article talks about the Health Products Regulatory Authority's (HPRA) Perspective on Multilingual Labeling. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Wed, 20 Apr 2022 12:05:40 +0000) |
| PAAB Complements the Standard Preclearance Pathway with Accelerated Review Options AROs |
| This article talks about the PAAB (Pharmaceutical Advertising Advisory Board) Complement on the Standard Pre-clearance Pathway with Accelerated Review Options (AROs). |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 15:15:26 +0000) |
| EMA Initiates DARWIN EU for RWE Integration in Medicines Assessment |
| On February 09, 2022, the European Medicines Agency (EMA) commenced the establishment of a Coordination Centre for Data Analysis and Real-World Integration Network (DARWIN EU®). It is the first step towards integrating Real-World Evidence (RWE) into assessing medicines across the European Union (EU |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 15:14:32 +0000) |
| Regulatory Overview on Sunscreens in Australia |
| Sunscreen is an important component of an effective sun protection regime. They must be safe, effective, and of good quality. For this reason, the TGA regulates sunscreens as therapeutic goods in Australia under the Therapeutic Goods Act 1989. The Australian Regulatory Guidelines for Sunscreens (ARG |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 15:13:56 +0000) |
| An Overview on Therapeutic Products Regulation in New Zealand |
| Medsafe, aka the New Zealand Medicines and Medical Devices Safety Authority, undertakes the regulation of therapeutic products in New Zealand. The Agency is a business unit of the Ministry of Health. It follows several legislations for regulating therapeutic products, the major ones being the Medici |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 15:13:06 +0000) |
| EMRN Adopts a Common ePI Standard for Medicines in the EU |
| The European Medicines Regulatory Network (EMRN) has adopted a common electronic Product Information (ePI) standard for human medicines. The common ePI standard was one of the major projects undertaken by the European Medicines Agency (EMA), the National Competent Authorities (NCA), and the European |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 15:12:10 +0000) |
| EU Notified Bodies NBs Proposed Solutions for MDR & IVDR Implementation Challenges |
| The European Notified Bodies (NBs) have published a new position paper to address the concerns of MDR/IVDR designated NBs. It will be effective from May 26, 2022 to May 26, 2024. The MDR/IVDR regulations aim to improve patient safety by strengthening the requirements for manufacturers and NBs. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 15:11:36 +0000) |
| Food Standards Australia New Zealand's FSANZ labeling standards for food products |
| As you may know, every country has its own set of regulations when it comes to labeling food products. Food labeling is a legal requirement and provides a wide range of information to help consumers make informed food choices. It protects public health and safety by displaying ingredients, use-by da |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 15:11:03 +0000) |
| FDA published a series of updated guidance documents |
| Recently, the FDA published three (03) guidance documents that focus on generic drug application submissions, labeling, and review. Among the three (03) guidance documents, two (02) are final drafts, and one (01) is a revised draft, which supports FDA’s Drug Competition Action Plan (DCAP) that was |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 15:10:28 +0000) |
| Responsible Person RP, A Fundamental Requirement of the Cosmetic Industry |
| To ensure that cosmetics align with the latest quality and safety standards, markets across the globe have stringent Regulatory requirements. In markets such as the European Union, the United Kingdom, Malaysia, India, Saudi Arabia, etc., appointing a Legal Representative/Responsible Person (RP)/ Loc |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 14:50:56 +0000) |
| US FDA Final Guidance on Population Pharmacokinetics |
| After nearly two (02) decades of issuing the first draft guidance, the United States Food and Drug Administration (US FDA) finalized the guidance on population Pharmacokinetics (PK) in February 2022. The latest draft explains the application of population PK in drug development and recommendations o |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 14:50:17 +0000) |
| USFDAâs Emergency Use Authorizations |
| Emergency Use Authorizations (EUAs) are significant in making life-saving medicinal products available to patients faster. They have been helpful in dealing with pandemics like COVID-19. An initiative of the United States Food and Drug Administration (USFDA) started in the year 2004, and the EUA cam |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 14:49:40 +0000) |
| EU Announces Clinical Trials Transformative Initiative |
| Currently, the European clinical trials environment is quite challenging. The COVID-19 pandemic has shown a relative absence of EU impactful, multi-state trials. In addition, the disharmony of Regulatory requirements between the Member States has complicated the submission of multi-state trial appli |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 04 Apr 2022 14:49:01 +0000) |
| WHO Considerations for Regulating Cell and Gene Therapy Products CGTPs |
| To promote global convergence among the Health Authorities and encourage the Member States to strengthen their Regulatory system on Cell and Gene Therapy products regulations, the WHO (World Health Organization) proposed a risk-based framework for regulating Cell and Gene Therapy Products (CGTPs). T |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 15 Mar 2022 13:48:24 +0000) |
| DADI, An Upcoming Regulatory Business Transformation Project from the EMA |
| This article talks about the EMA designed Digital Application Dataset Integration (DADI) project acts as replacement for the PDF-based electronic Application Form (eAF), which was incepted to support eCTD submissions.
In addition to completing the requisite xEVMPD data submissions, life sciences or |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 03 Mar 2022 13:00:11 +0000) |
| Pharmaceutical Labels and Errors to Avoid |
| A pharmaceutical label is a monologue between the drug manufacturer and the patients. Miscommunication of any kind can affect the end-user. To protect the interest of the patient population, global Health Authorities (HAs) closely monitor pharmaceutical labels and indications of pre-approval. There |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Mar 2022 11:47:07 +0000) |
| Regulation for Hair Colorants in the EU |
| Hair colorants are classified as cosmetic products by the European Commission (EC) and are regulated under the regulation (EC) No: 1223/2009. Hair colorants contain a mixture of substances called hair dyes that are used to change the color of hair or to restore the original hair color. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Mar 2022 11:46:31 +0000) |
| Key Highlights from FSSAI Published Front Pack of Labelling FOPL Update |
| FSSAI published a major update on the Front Pack of Labelling (FOPL) on 22nd February 2022 after a meeting with the stakeholders, to decide the remaining issues related to ‘Front of Pack Labelling’ under the Chairmanship of CEO, FSSAI. The FSSAI commenced the meeting with a presentation on the d |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Mar 2022 11:44:15 +0000) |
| ECsâ Electronic-IFU eIFU rules for medical devices |
| Medical devices need an efficient, effective, and readily available user manual. Over time, paper Instructions for Use (IFU) have been the norm in the medical device industry. However, with the advent of electronic technologies, the paper IFU has been replaced by electronic IFU (eIFU). |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Mar 2022 11:43:40 +0000) |
| SPC Exception is a Boon for Generics and Biosimilars Manufacturers in the EU Market |
| While innovators or branded drug products carry additional costs associated with the research and development of the product from the molecule identification stage to post-market authorization, generic drug products are relatively cost-effective. These therapies not only reduce the overall cost of t |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Mar 2022 11:42:42 +0000) |
| Health Canadaâs Preferred ANDS Gateway for Generic Drugs |
| Canada ranks ninth in the world in value for generic drugs and has reached $5.8bn in sales as of today in 2022. To make effective, safe, and affordable drugs readily available to patients in the country, Health Canada – Canada’s Health Authority, is taking initiatives to improve the accessibilit |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 01 Mar 2022 11:42:04 +0000) |
| MHRAâs Novel Approach for Enhanced Accessibility of Innovative Drugs in UK |
| To enhance the accessibility of innovative medicines for patients in the UK post-Brexit, a new and accelerated approval pathway is known as the Innovative Licensing and Access Pathway (ILAP) was launched in January 2021. Its primary objective was to provide an integrated roadmap for all the stakehol |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Feb 2022 09:33:18 +0000) |
| Comparative Analysis of TGAâs 2018 and 2021 Advertising Codes |
| To educate patients and Health Care Professionals (HCPs) and promote treatment options, the pharmaceutical industry like many other industries dedicates billions of dollars to advertise and promote prescription drugs. The legislative framework of advertising in Australia comes under Section 42BAA of |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Feb 2022 09:32:27 +0000) |
| Obligations of Economic Operators EOs under the Swissmedicâs MedDO |
| There are various Economic Operators (EOs) who play a vital role in a device supply chain while delivering them to the point of use. Given the importance of each role, the Swiss Medical Device Ordinance (MedDO; SR 812.213) has set out the roles and responsibilities for each of these EOs. The three ( |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Feb 2022 09:31:32 +0000) |
| FDAâs Alternative Methods to Reduce Nitrosamine Impurity Levels in Drugs |
| This article talks about the FDA’s alternative methods to reduce Nitrosamine Impurity levels in drug products. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Feb 2022 09:30:54 +0000) |
| EC Plans to prevent Disruption of Medicines Supply Post-Brexit for Northern Ireland |
| Based on the European Commission’s (EC) proposal on facilitating the movement of goods from Great Britain to Northern Ireland in October 2021, the Commission has now set up plans to maintain the medicines’ supply in specific markets post-Brexit. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Feb 2022 09:30:11 +0000) |
| EMAâs Initiative for Regulatory Science Research Needs |
| To note, there are many gaps in the Regulatory science that need to be addressed for the development and evaluation of medicine. Global Regulatory Agencies make strong efforts to close these gaps and enable access to innovative medicines that address the patient’s needs. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Thu, 24 Feb 2022 09:28:36 +0000) |
| Reasons and Ramifications for Warning Letters 483s |
| A warning letter is an official message/letter issued from a health authority to an organization that violates the set rules and regulations. When it relates to pharmaceutical companies, they need to follow several Good Manufacturing Practices (GMPs), GCPs, GDPs, etc., to avoid such warnings. There |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Mon, 10 Jan 2022 12:30:58 +0000) |
| Do I need a prescription to buy medicine online? |
| You cannot get prescription medicines without a prescription. A legal medicine supplier will never give you prescribed medicines if you do not have a prescription from a doctor after taking the doctor online consultation. Doctors, including online doctors, may only prescribe you medicines if they me |
| Author: Do I need a prescription to buy medicine online? |
| Directory: Health |
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| (Published: Mon, 10 Jan 2022 08:04:10 +0000) |
| Telemedicine Benefits: Patients and Professionals |
| Telemedicine is a method of providing medical care remotely, usually through video chat. Telemedicine offers a range of benefits for patients and healthcare providers both through doctor app.
It is possible to access a wide range of care options through telemedicine services, including primary care |
| Author: Do I need a prescription to buy medicine online? |
| Directory: Health |
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| (Published: Mon, 03 Jan 2022 13:38:11 +0000) |
| What does a pharmacist do? |
| Online medicine order is necessary if you want medicine delivered at home
Pharmacist are responsible for:
Quality of medicines supplied to patients
Supply of medicines is as per the law
Medicines prescribed to patients are suitable
Advice patients about medicines, including how to consume it, |
| Author: Do I need a prescription to buy medicine online? |
| Directory: Health |
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| (Published: Mon, 27 Dec 2021 11:00:38 +0000) |
| Top 5 Apps to Order Medicine Online in India |
| After pandemic the trend has extended to healthcare apps who provide online doctor appointment and access to other medical services.
Now we can order medicines online through websites, which prevents you from long hour waiting in queue from medical pharmacy stores.
The online medicine apps are of |
| Author: Do I need a prescription to buy medicine online? |
| Directory: Health |
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| (Published: Mon, 27 Dec 2021 05:45:32 +0000) |
| 7 reasons patients don't take their medications |
| Medication nonadherence—when patients don’t take their medications as prescribed—is unfortunately fairly common, especially among patients with chronic disease. When this is the case, it is important for physicians and other health professionals to understand why patients don’t take their me |
| Author: Do I need a prescription to buy medicine online? |
| Directory: Health |
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| (Published: Thu, 23 Dec 2021 07:38:20 +0000) |
| How to beat fatigue? |
| Tired all the time is a popular complaint, tiredness and fatigue are common problems. It can be reversed by a change of lifestyle.
Tiredness can negatively impact performance at work, family life, social relationships. Fatigue has a reputation as a vague and difficult problem for doctors to invest |
| Author: Do I need a prescription to buy medicine online? |
| Directory: Health |
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| (Published: Thu, 23 Dec 2021 05:19:40 +0000) |
| Apps to order medicines online in india |
| Due to COVID-19 lockdown online medicine comes out as a boon for the medical stores.
Online medical stores offer the convenience of pharmaceutical deliveries at home. Most have a wide variety of healthcare products. With few clicks and online discounts we get online medicine order delivered at doo |
| Author: Do I need a prescription to buy medicine online? |
| Directory: Health |
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| (Published: Tue, 21 Dec 2021 13:31:18 +0000) |
| USFDA Guidance on Electronic 510k Submission for Medical Devices |
| This article talks about the USFDA issued guidance on Electronic 510(k) Submission for Medical Devices and benefits of the eSTAR.
Medical Devices, 510(k) submissions, FDA, CDRH, eSTAR, Regulatory Affairs, US FDA, Electronic Submission |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 21 Dec 2021 13:30:16 +0000) |
| MHRA Extends the Free PPE Scheme till March 21, 2022 |
| This article talks about the UK’s MHRA extended free PPE Scheme till March 21, 2022 to control the rapid spread of COVID-19. This article talks about the UK’s MHRA extended free PPE Scheme till March 21, 2022 to control the rapid spread of COVID-19. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 21 Dec 2021 13:29:24 +0000) |
| FDA Essential Documents for Software as a Medical Device SaMD Pre-market Submissions |
| This article talks about the FDA essential documents needed for Software as a Medical Device (SaMD) pre-market submissions to ensures patient safety and device efficiency. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 21 Dec 2021 13:28:28 +0000) |
| MHRA to update Regulations of Software and AI as a Medical Device |
| This article talks about the UK’s MHRA to update Regulations of Software and AI(artificial intelligence) as a Medical Device.
Medical Devices, SaMD, AiaMD, Software as a Medical device, Artificial Intelligence, MHRA, Medicines and Healthcare products Regulatory Agency, artificial intelligence |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 21 Dec 2021 13:27:24 +0000) |
| List of Common Misconceptions about Meetings with the MHRA |
| This article talks about the List of Common Misconceptions about Meetings with the MHRA. MHRA, Pharmaceuticals, Marketing Authorization, Regulatory Consulting, MA, Medicines and Healthcare products Regulatory Agency |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 21 Dec 2021 13:26:23 +0000) |
| The Opportunity for Generic Companies and Value-Added Medicines in Africa |
| This article talks about the opportunity for Generic companies and Value-Added Medicines in Africa. Market Access, Regulatory Affairs, Registration Strategy, Generic, Generic Companies, Value added medicines, African market |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 21 Dec 2021 13:25:03 +0000) |
| Deadline for Converting CAPs to UK Mas |
| This article talks about the deadline for converting CAPs (Centrally Authorised Products) to UK MAs(Marketing Authorisations) before December 31, 2021. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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| (Published: Tue, 21 Dec 2021 13:24:27 +0000) |
| Benefits of leveraging AIML for RIM digital transformation |
| This article talks about the benefits of leveraging AI (Artificial Intelligence)/ML (Machine Learning) for RIM digital transformation to achieve regulatory goals. |
| Author: Freyr Solutions Inc |
| Directory: Health |
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