Search Results for

Filtering on: "organizations agencies/organizations ema"

Showing 1 – 25  of 762

Researchers Call on FDA to Follow EMA's Lead in Publishing Study Reports By Michael Mezher - Published 22 February 2017

Two researchers are calling on the US Food and Drug Administration (FDA) to follow the European Medicines Agency's (EMA) lead in proactively publishing clinical study reports.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs

Tags: Clinical Trial Transparency

TTIP on Thin Ice Likely to Delay US-EU Mutual GMP Recognition Deal By Zachary Brennan - Published 22 February 2017

A deal to further harmonize and mutually recognize good manufacturing practice (GMP) inspections between the US and EU has run into a speed bump, as the EU ambassador to the US said Wednesday that the Transatlantic Trade and Investment Partnership (TTIP) is in a state of pause as there is no one within President Donald Trump’s administration with whom to continue discussions.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: mutual GMP recognition, TTIP, EU-US trade deals

EMA Outlines GCP Inspection Plan for 2017 By Zachary Brennan - Published 21 February 2017

The European Medicines Agency (EMA) on Tuesday released its 2017 work plan for good clinical practice (GCP) inspections, which involves collaborating with the US Food and Drug Administration (FDA) to limit duplicative inspections.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: GCP guidelines, GCP inspections, trial site inspections

Transparency Push: EMA to Revise Policy on Document Access By Zachary Brennan - Published 17 February 2017

The European Medicines Agency (EMA) on Friday proposed a revision to its policy on accessing documents, extending the scope to include corporate documents, and increasing the publication of clinical data for pharmaceuticals.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Due Diligence, Government affairs

Tags: pharmaceutical data transparency, EMA transparency

CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics By Michael Mezher - Published 16 February 2017

The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children.

Categories: News, EMA, FDA, Clinical, Drugs

Tags: Pediatric clinical trials, Antibacterial, Antibiotics, CTTI, Clinical Trials Transformation Initiative

European Regulatory Roundup: House of Lords Backs Change to Drug Pricing Bill to Appease Pharma Industry (16 February 2017) By Nick Paul Taylor - Published 16 February 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Business and Leadership, Government affairs

Tags: European regulatory roundup, biosimilars, Brexit

EMA Weighs New Guideline on Quality Requirements for Combination Products By Zachary Brennan - Published 16 February 2017

The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product.

Categories: News, Europe, EMA, Combination products, Quality

Tags: combination products, notified bodies, quality requirements

EMA Reviews Safety of PAH Medicine Following 5 Deaths in France By Zachary Brennan - Published 14 February 2017

The European Medicines Agency (EMA) signaled Tuesday that doctors can continue to use Actelion Pharmaceuticals’ pulmonary arterial hypertension (PAH) medicine Uptravi (selexipag) while the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) evaluates its safety following the deaths of five patients taking the medicine in France.

Categories: News, Europe, EMA, Crisis management, Drugs, Government affairs

Tags: Uptravi, PRAC, Actelion

EMA’s Pediatric Committee Seeks to Tweak ICH Q&A on Nonclinical Evaluation of Cancer Drugs By Zachary Brennan - Published 13 February 2017

The European Medicines Agency’s (EMA) Pediatric Committee has offered a couple of comments, slight tweaks and further suggestions for the International Council for Harmonisation’s (ICH) draft question and answer document on its S9 guideline on the nonclinical evaluation for anticancer pharmaceuticals.

Categories: News, Europe, EMA, ICH, Biologics and biotechnology, Clinical, Drugs

Tags: PDCO, EMA committee, ICH Q&A, S9

EMA Touts Growth of Post-Authorisation Study Database By Michael Mezher - Published 13 February 2017

The European Medicines Agency (EMA) on Friday announced it has published more than 1,000 post-authorization studies in a public online database.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: Post-Authorisation Studies, PAS, EU PAS Register

EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses By Zachary Brennan - Published 13 February 2017

With an eye toward more harmonization, the European Medicines Agency (EMA) earlier this month weighed in on the US Food and Drug Administration’s (FDA) draft guidance on physiologically based pharmacokinetic (PK) analyses, alongside pharmaceutical companies including Novartis, Merck and Bayer.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: PBPK modeling and simulation, EMA and FDA harmonization, Bayer, Merck, Novartis

European Regulatory Roundup: ENVI Calls to for EMA Budget Reserves in Case of Brexit Volatility (9 February 2017) By Nick Paul Taylor - Published 09 February 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs

Tags: European regulatory roundup, Brexit, ENVI, aripiprazole, Hospira

EMA Explains How it Supports Article 58 Applications By Michael Mezher - Published 07 February 2017

The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs).

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, EMA, WHO, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Article 58, Scientific Advice, Business Pipeline Meeting

Regulatory Intelligence, Leading Edge Technology, Compliance Strategy, Scientific Research and a Preview of February By Gloria Hall - Published 06 February 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in February.

Categories: Features, China, Canada, Europe, US, CFDA, EMA, FDA, Health Canada, Biologics and biotechnology, Compliance, Drugs, Medical Devices, Regulatory intelligence, Submission and registration

Tags: Regulatory Focus, Feature Articles, Feature Summary

Challenges Surrounding the Development and Manufacturing of ATMPs Continue By Zachary Brennan - Published 03 February 2017

The experience of conducting clinical trials with advanced therapy medicinal products (ATMPs) in a real-world clinical setting, according to a new European Medicines Agency (EMA) summary of a conference discussion, can mean “battling multiple and often ridiculous barriers.”

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Blood, Combination products, Manufacturing

Tags: ATMPs, EMA conferences

European Regulatory Roundup: Lead Brexiteer Muddies Waters on UK-EMA Relationship (2 February 2017) By Nick Paul Taylor - Published 02 February 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Brexit, Jeremy Hunt, David Davis, Guido Rasi

Where to Find Publicly Disclosed Regulatory Precedent in the EU, US and Canada By Linda Bowen, MS, RAC, João Duarte, MPharm - Published 01 February 2017

This article provides a better understanding of the types of information available from regulatory authorities by outlining sources of precedent focused on development activities, regulatory submission and evaluation, and approval and post-authorization activities.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs, Labeling, Regulatory strategy, Submission and registration

Small Organizations, Big Regulatory Strategy By Angela Johnson, MSE, PMP, RAC - Published 30 January 2017

This article discusses how small and young organizations, including start-ups, build powerful regulatory strategy programs that complement their research and business development efforts. Established businesses also can learn from their innovative approaches. These include navigating incentives, understanding and utilizing technology tools for regulatory intelligence like social media and crowdsourcing, and embracing a team mentality to build agile and efficient regulatory programs with a strong underlying alignment with business development.

Categories: Features, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: Regulatory Strategy, SMEs

Regulatory Intelligence - an Integrated Tool to Strengthen Drug Development Projects and Regulatory Strategies By João Duarte, MPharm, Anne Vinther Morant, PhD, MSc - Published 27 January 2017

This article discusses the role of regulatory intelligence in drug development as well as the functional and personal competencies desired for a regulatory intelligence professional to succeed in providing value to the research and development organization.

Categories: Features, EMA, FDA, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Intelligence

EMA Recommends Two Amgen Humira Biosimilars By Zachary Brennan - Published 27 January 2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended eight medicines for approval, including two Amgen biosimilars for AbbVie’s blockbuster Humira (adalimumab).

Categories: News, Asia, Europe, US, EC, EMA, FDA, Biologics and biotechnology

Tags: Humira, Amgen, AbbVie, blockbuster drugs

European Regulatory Roundup: UK to Seek ‘Closest Possible Regulatory Equivalence’ With EMA Post-Brexit (26 January 2017) By Nick Paul Taylor - Published 26 January 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Business and Leadership, Drugs, Government affairs, Medical Devices

Tags: European Regulatory Roundup, Brexit, Theresa May, NICE Chair

Regulatory Intelligence - Delivering Regionally, Operating Globally By Emily Huddle, BSc, Soufiane Dib, PharmD, Marie Claire Aquilina, MPharm, MSc - Published 25 January 2017

This article discusses the impact of the Internet with regard to the amount and transparency of information offered by regulatory health agencies with an emphasis on the role of regulatory intelligence in monitoring the global environment and the subsequent communication obtained from this information.

Categories: Features, EMA, FDA, ICH, Drugs, Regulatory intelligence

EMA Updates Q&A on Article 31 Referrals By Michael Mezher - Published 24 January 2017

The European Medicines Agency (EMA) on Tuesday issued a new version of its questions and answers (Q&A) guide on Article 31 non-pharmacovigilance referrals.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Quality

Tags: Article 31 referral, Article 31

EMA Reflects on its First Decade of Conditional Marketing Authorizations By Michael Mezher - Published 24 January 2017

Ten years after the development of the conditional marketing authorization (CMA) pathway, European Medicines Agency (EMA) on Monday said the program is working as intended, and has led to earlier patient access to 30 drugs, nearly half of which were for orphan indications, and 80% of which target seriously debilitating or life-threatening conditions.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: Conditional Marketing Authorisation, CMA

European Commission Offers New Q&A on Biosimilars By Zachary Brennan - Published 23 January 2017

The European Commission on Monday unveiled a new question and answer document for those looking to better understand biosimilars.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, biosimilar workshop