Results from Tags

 

EMA - E-submission – New requirements as of 1 July 2015:

Starting on 1 July 2015, companies should send all applications for the centralized procedure in eCTD format only via the EMA’s eSubmission Gateway.
von Marc Dittes am 07.07.2015, 12:01

News Updates about the EMA

The EMA has published the presentations of the "SME Workshop: Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies" that took place on 16 April 2015. In addition, the video recording of the whole event is made available which is a great resource for everyone who couldn’t attend the workshop in person.
von Marc Dittes am 13.06.2015, 12:32

Western European markets for biosimilar and generic drugs

Garattini L et al. from the Center for Health Economics, IRCCS Institute for Pharmacological Research 'Mario Negri', Italy, published an article entitled "Western European markets for biosimilar and generic drugs: worth differentiating" on 20 March 2015 issue of the European Journal of Health Economics.
von William Chin am 24.03.2015, 09:36

Integration of genomics in the regulatory decision-making process

Tong W et al. from the National Center for Toxicological Research, US Food and Drug Administration published an article entitled “Genomics in the land of regulatory science” in the 18 March 2015 issue of the Regul Toxicol Pharmacol journal.
von William Chin am 23.03.2015, 11:59

The FDA reports were more difficult to use than the EMA reports?

A recent research paper entitiled "The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports" was published in the January 2015 issue of Journal of Clinical Epidemiology.
von William Chin am 20.03.2015, 09:13

EMA launches 20th anniversary book

The European Medicines Agency (EMA) has been published an anniversary book to mark 20 years anniversary. This informative book captures the progress in medicines regulatory science by EMA over the past 20 years.
von William Chin am 19.03.2015, 07:47

Pharmacists are in favour with biosimilars having the same nonproprietary name as the reference biologic

A recent paper entitled "Assessment of pharmacists' views on biosimilar naming conventions" was published in the March 2015 issue of the Journal of Managed Care & Specialty Pharmacy. Fernandez-Lopez S et al. conducted a survey among the Academy of Managed Care Pharmacy (AMCP), the American Pharmacists Association (APhA), and the American Society of Health-System Pharmacists (ASHP) members with the primary aim to determine the impact of identical or different non-proprietary names on pharmacists’ confidence in substituting interchangeable biologics.
von William Chin am 18.03.2015, 07:50

European Medicines Agency 20th anniversary scientific conference

EMA's 20th anniversary scientific conference - "Science, Medicines, Health: Patients at the heart of future innovation" on 18 March 2015.
von William Chin am 17.03.2015, 09:26

Industry news: What happen last week?

Weekly pharma news roundup.
von William Chin am 16.03.2015, 08:55

The Transatlantic Trade and Investment Partnership: Myths vs Facts

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have partnered up to form the Transatlantic Trade and Investment Partnership (TTIP). This partnership aims to create an open trade between the EU and the US, foster research collaborations and to accelerate access of new treatment options to patients.
von William Chin am 13.03.2015, 09:11

Pharmacovigilance from social media - is it possible?

It seems like it is possible to extract complex medical concepts from social media posts. A research paper entitled "Pharmacovigilance from social media: mining adverse drug reaction mentions using sequence labeling with word embedding cluster features" was published in the March 2015 issue of the Journal of the American Medical Informatics Association.
von William Chin am 12.03.2015, 10:16

Upcoming publications from the European Network of Paediatric Research at the European Medicines Agency

In a newsletter published on the 10 March 2015, the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has outlined several activities for the year 2015. These include commitment to several publications.
von William Chin am 11.03.2015, 08:37

Adopted guidelines by CHMP: February 2015 updates

The European Medicines Agency (EMA) regularly publishes guidelines which have been adopted during the Committee for Medicinal Products for Human Use (CHMP).
von William Chin am 10.03.2015, 08:21

Industry news: What happen last week?

Weekly pharma news roundup.
von William Chin am 09.03.2015, 11:01

Comparative effectiveness and relative efficacy: Expectations for drugs in the US and EU in 2020

In this paper entitled “The future of comparative effectiveness and relative efficacy of drugs: an international perspective” published in the March 2015 issue of the Journal of Comparative Effectiveness Research, Messner DA et al. addressed the question of how the evidence requirement for comparative effectiveness research in the US and relative effectiveness in the EU will evolve in the next 5 years.
von William Chin am 06.03.2015, 09:14

A review of current status and future perspectives for novel biotherapeutics

A review paper entitled "Beyond peptides and mAbs—current status and future perspectives for biotherapeutics with novel constructs" was recently published in the March 2015 issue of the Journal of Clinical Pharmacology.
von William Chin am 05.03.2015, 09:50

The European industry perspective on risk-based immunogenicity testing

A recent review entitled “A fit-for-purpose strategy for the risk-based immunogenicity testing of biotherapeutics: a European industry perspective” was published in the February 2015 issue of Journal of Immunological Methods.
von William Chin am 04.03.2015, 09:00

Scientific recommendation on classification of ATMPs - February 2015 reports

A series of reports were published by the Committee for Advanced Therapies (CAT) on the scientific recommendations on classification of advanced therapy medicinal products.
von William Chin am 03.03.2015, 12:32

February 2015 meeting highlights of the Committee for Medicinal Products for Human Use

Three new medicines have received recommendations for approval and 6 currently approved medicines have received recommendations on extensions of therapeutic indication from the Committee for Medicinal Products for Human Use (CHMP).
von William Chin am 02.03.2015, 10:18

Mandatory use of electronic application forms for human and veterinary procedures in EU

The European Medicines Agency (EMA) has published that from 1 January 2016 the application forms in Word format published by the European Commission will no longer be available. Paper based application will be phased out and replaced with the electronic application format.
von William Chin am 26.02.2015, 15:41

5th Annual Biopharmaceuticals Meeting Report 2015

Once again, Munich served as the host city for the 5th Annual Biopharmaceuticals Meeting on February 5-6, 2014, which gathered 110 participants from 16 countries that are actively involved in regulatory affairs of biopharmaceuticals.
von William Chin am 24.02.2015, 12:13

Industry news: What happen last week?

Weekly pharma news roundup.
von William Chin am 23.02.2015, 14:30

Promising Phase 3 results for Amgen's biosimilar of Humira

On February 3, 2015, Amgen has announced a promising result of its Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared with Humira® (adalimumab).
von William Chin am 19.02.2015, 09:59

Recommendation of changes to product information translated into all official languages of the EU

In order to facilitate consistent implementation of product-information changes across the EU and reduce administrative burden for stakeholders, the European Medicines Agency (EMA) has started to translate its recommendation based on the assessment of safety signals - 3 weeks after publication in English - into all official languages of the European Union (EU) as well as Norwegian and Icelandic.
von William Chin am 19.02.2015, 07:38

Defining naïve patient for biological drug use is challenging

A recent review entitled "The challenging definition of naïve patient for biological drug use" was published on the 31 Jan 2015 issue of Autoimmunity Reviews.
von William Chin am 18.02.2015, 13:32

The “PaedForm” project

The “PaedForm” project promotes accessibility to suitable and age-appropriate unlicensed medicines for children.
von William Chin am 18.02.2015, 08:25

Factors influencing decision-making in drug development and regulatory review

What are the important issues that influence decision-making in the pharmaceutical industry and regulatory authorities?
von William Chin am 16.02.2015, 16:22

Why certain information of the clinical study report is redacted?

On 10 February 215, the European Medicines Agency (EMA) has published a letter to the European Ombudsman’s questions related to the redaction of information in clinical study reports for the medicine Humira. The explanation provided by EMA is in response to the Ombudsman's letter dated 27 October 2014.
von William Chin am 12.02.2015, 07:03

Fire on the patent dance floor

Cassandra Willyard published an article entitle "Biosimilar makers flout forced patent negotiations in US" on the 5 February 2015 issue of the Nature Medicine. The article reported on the ongoing patent dispute between Amgen and Sandoz over a biosimilar version of Neupogen (filgrastim), produced by Amgen.
von William Chin am 11.02.2015, 11:14

FDA-EMA Collaboration in Pharmacovigilance

The European Medicines Agency (EMA) has published an article reporting the formation of a cluster on pharmacovigilance topics.
von William Chin am 09.02.2015, 18:25

FDA's breakthrough therapy designation to LentiGlobin for treatment of beta-thalassemia major

Yesterday, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to LentiGlobin® BB305 for the treatment of transfusion-dependent patients with beta-thalassemia major.
von William Chin am 03.02.2015, 10:14

Characteristics of drug combination therapy in oncology by analyzing clinical trial data on clinicaltrials.gov

Drug combination therapy has the potential to improve treatment response, minimize development of resistance or minimize adverse events. A recent study entitled "Characteristics of drug combination therapy in oncology by analyzing clinical trial data on clinicaltrials.gov." was recently pubished at the Journal of Pacific Symposium on Biocomputing.
von William Chin am 02.02.2015, 22:21

The European network of paediatric research-European Medicines working groups

Enpr-EMA has created Working Groups (WGs) within its organization with the aim of developing pragmatic responses to some of the needs relating to paediatric medicines research that can be implemented within six months.
von William Chin am 02.02.2015, 22:21

50 years of EU pharmaceutical legislation

2015 marks 50 years of pharmaceuticals legislation in the EU.
von William Chin am 30.01.2015, 20:19

EMA launched central repository to facilitate assessment of medicines safety reports

EMA launched central repository to facilitate assessment of medicines safety reports.
von William Chin am 29.01.2015, 10:33

EMA celebrates 20th anniversary

The European Medicines Agency (EMA) celebrated its 20th anniversary on the 26 January 2015.
von William Chin am 28.01.2015, 09:13

Ebola crisis: The unequal impact on women and children's health

Menéndez et al reported that sociocultural and health-care-related factors contributed to the increase risks factors for women in the Ebola outbreak in west Africa.
von William Chin am 27.01.2015, 12:30

Gross profit margin of selected biotech and drugs companies as of Q3 2014

Gross profit margin of selected biotech and drugs companies as of Q3 2014.
von William Chin am 27.01.2015, 10:17

7 new medicines recommended by CHMP for approval in January 2015

The European Medicines Agency has recommended suspension of authorised medicines n based on clinical trial conducted by Hyderabad, India based GVK Biosciences.
von William Chin am 26.01.2015, 15:59

Flawed clinical data from GVK Biosciences caused suspension of 700 pharmaceutical forms and strengths of medicines in EU

The European Medicines Agency has recommended suspension of authorised medicines n based on clinical trial conducted by Hyderabad, India based GVK Biosciences.
von William Chin am 26.01.2015, 13:35

Strengthening international collaborations on generics

EMA has reported that it will share assessments reports for generic medicines with regulatory agencies outside the EU.
von William Chin am 21.01.2015, 17:59

Risk attitudes and personality traits predict perceptions of benefits and risks for medicinal products among European medical assessors

Have you ever wonder how do regulators at EMA evaluate the benefit and risk of medicinal drugs? What are the factors that contribute to the ability to judge the risks and benefits of the medicinal products?
von William Chin am 20.01.2015, 12:32

"Patent dance" for the first biosimilar in the US

As the first biosimilar drug from Sandoz (reference product = filgrastim (Neupogen) by Amgen) is set to enter US market pending FDA's final decison in May 2015 , it is of course not without any hurdles.
von William Chin am 19.01.2015, 14:43

New legislation on Medical Device

In September 2012, the European Commission published a proposal for a new regulation on Medical Devices, which was amended by the Parliament in October 2013.
von William Chin am 14.01.2015, 18:22

Future approach to development pathways for advanced therapy medicinal products (ATMP)

Advanced therapy medicinal products (ATMPs) are governed by Directive 2001/ 83/EC [3] and Regulation 726/2004, amended by Regulation 1394/2007, which sets specific rules concerning their centralized marketing authorization (MA), supervision and pharmacovigilance in Europe.
von William Chin am 13.01.2015, 15:16

Record number of orphan designated medicines recommended for approval in 2014

The year 2014 saw the highest number of orphan designated medicines granted approval for marketing authorisation.
von William Chin am 12.01.2015, 17:41

Publication of clinical data by EMA comes into force 1 January 2015

European Medicines Agency policy on publication of clinical data for medicinal products for human use has entered into force on 1 January 2015.
von William Chin am 09.01.2015, 09:14

Sandoz biosimilar filgrastim recommended for approval in the USA

Sandoz announced that US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of its investigational biosimilar filgrastim in the US.
von William Chin am 08.01.2015, 18:01

EMA and EFPIA workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products

Dose-finding study is an essential phase of drug development where studies need to be conducted to determine the drug dose to be administered to patients with the best expected balance of safety and efficacy.
von William Chin am 08.01.2015, 08:36

Consultation open for draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products

The draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products is now open for consultation from the 6 January to 7 February 2015.
von William Chin am 07.01.2015, 15:43

Human medicines European public assessment report (EPAR) for Masiviera : Refusal

The human medicines European public assessment report (EPAR) for Masiviera (masitinib) has just been published by EMA.
von William Chin am 06.01.2015, 13:48

Updated dates of 2015 SAWP meetings

The Scientific Advise meeting is a highly informative session that provides better alignment of the possible positioning of new medicines with the clinical evidence with regulators.
von William Chin am 06.01.2015, 11:58

Update on the status of the adaptive pathways pilot project at EMA

Out of 34 requests for assessement of dossiers through the adaptive pathways, only six medicines were selected to go forward in the pilot project.
von William Chin am 23.12.2014, 14:24

First stem-cell therapy recommended for approval in EU

In the last meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) of the year 2014, Holoclar, the first advanced therapy medicinal product (ATMP) containing stem cells, has been recommended for approval in the EU.
von William Chin am 22.12.2014, 14:27

TOPRA 2014 Award in London - Travel diary by William Chin

I boarded my flight from Germany. Packed with my best suit in my luggage, I am all set and excited to fly to London.
von William Chin am 20.12.2014, 13:13

Not enough safety and efficacy evidence for any of the experimental therapies for Ebola virus

The European Medicines Agency (EMA) published an interim report on seven experimental medicines intended for the treatment of people infected with the Ebola virus.
von William Chin am 17.12.2014, 09:30

EMA adaptive pathways pilot project

Regulators and scientists at the European Medicines Agency (EMA) as well as from other regulatory agencies, academia and industry have recently published an article in Clinical Pharmacology and Therapeutics, stating their position on the adaptive pathways of drug approval.
von William Chin am 16.12.2014, 19:30

Adaptive clinical trial designs for European marketing authorization

Adaptive clinical trial design is a confirmatory clinical trials with flexible design and analysis plan, that is a frequently considered for clinical trials by sponsors.
von William Chin am 12.12.2014, 10:49

Non-compliance of Good Clinical Practice at GVK Biosciences in India led to suspension of marketing authorisations of concerned medicines

Back in September 2014, the French medicine agency reported concerns on the reliabiity of the quality data from clinical studies conducted between 2008 and 2014 by GVK Biosciences site in India.
von William Chin am 08.12.2014, 14:24

Step-wise approach to develop biosimilar focusing on quality and clinical efficacy

Recently, European regulators have published 2 review articles addressing the use of animal studies in demonstrating similarity of biosimilar. The consensus is that biosimilar should be developed based on a stepwise approach to demonstrating biosimilarity.
von William Chin am 04.12.2014, 08:50

Serious adverse events of Novartis flu vaccine Fluad

EMA has reported that the agency is working closely with AIFA to investigate the cause of serious adverse events in elderly patients who had received Fluad, flue vaccine.
von William Chin am 03.12.2014, 11:12

Sequence of events surrounding the resignation of EMA's Executive Director

Mr. Guido Rasi who was appointed 3 years ago as the Executive Director of EMA, has been forced to step down.
von William Chin am 02.12.2014, 09:31

White paper on continuous bioprocessing

Greater demands on the development of biologics with emphasis on higher titers, greater efficiency and higher utilization has called for continuous bioprocessing in the manufacturing of biologics.
von William Chin am 26.11.2014, 18:23

EMA releases practical guidance on access-to-documents requests

Do you know that according to EMA's 2010 access-to-documents policy, citizens can have access to all documents held by EMA?
von William Chin am 25.11.2014, 16:13

Immunogenicity: Understanding the Regulatory Philosophy Workshop Summary

The workshop report is now available! Check it out the major outcomes of the sessions.
von William Chin am 21.11.2014, 16:56

Seminar 9 - Diary by William Chin

William Chin summarised Seminar 9 of the EUCRAF MSc course held on the 9th-11th Oct 2014.
von William Chin am 04.11.2014, 08:49

Seminar 8 - Diary by William Chin

William Chin summarised Seminar 8 of the EUCRAF MSc course held on the 3rd-6th Sept 2014.
von William Chin am 11.09.2014, 14:32

Seminar 7 - Diary by William Chin

William Chin summarised Seminar 7 of the EUCRAF MSc course held at Strasbourg, France on the 16th-18th July 2014.
von William Chin am 29.07.2014, 11:35

4th Annual Biopharmaceuticals Meeting Report 2014

See details of EUCRAF 4th Annual Biopharmaceuticals Meetings Report held on 27th-28th February 2014.
von Anita Dioszegi am 14.07.2014, 11:35

Seminar 6 - Diary by William Chin

William Chin summarised Seminar 6 of the EUCRAF MSc course held on the 11th-14th June 2014.
von Zsuzsanna Nandori am 02.07.2014, 13:30

Seminar 5 - Diary by William Chin

William Chin summarised Seminar 5 of the EUCRAF MSc course held on the 8th-10th May 2014.
von Anita Dioszegi am 26.05.2014, 09:01

Seminar 4.2 - Diary by William Chin

William Chin summarised Seminar 4.2 of the EUCRAF MSc course held on the 4th-8 March 2014.
von Marc Dittes am 21.03.2014, 14:51

Seminar 4.1 - Diary by William Chin

William Chin summarised Seminar 4.1 of the EUCRAF MSc course held on the 21st-24th Jan 2014.
von Zsuzsanna Nandori am 07.02.2014, 09:41

Seminar 3 - Diary by William Chin

William Chin summarised Seminar 3 of the EUCRAF MSc course held on the 4th-7th Dec 2013.
von Zsuzsanna Nandori am 13.01.2014, 10:14

Merry Christmas!

On behalf of the whole EUCRAF team we wish you a Merry Christmas and a Succesful New Year!
von Anita Dioszegi am 23.12.2013, 13:02

Seminar 2 - Diary by William Chin

William Chin summarised Seminar 2 of the EUCRAF MSc course held on the 29th Oct - 2nd Nov 2013.
von Zsuzsanna Nandori am 11.11.2013, 14:00

Seminar 1 - Diary by William Chin

William Chin summarised Seminar 1 of the EUCRAF MSc course held on the 10th-14th Sept 2013.
von Marc Dittes am 23.09.2013, 11:14

Seminar 1 about to end

von Marc Dittes am 13.09.2013, 13:33

Review on Seminar 8

von Marc Dittes am 13.09.2013, 13:28

Seminar 7 - Straßbourg

von Zsuzsanna Nandori am 19.07.2013, 11:59

Launch of the Shop

EUCRAF proudly presents its cyberspace where you can watch our presentations on-line, or register online to most of our presentations
von Anita Dioszegi am 18.07.2013, 13:14

One day to go to the China Coaching Event!

von Zsuzsanna Nandori am 03.07.2013, 15:23

Launch of the new website!

Launch of the new website and the on-line shop.
von Anita Dioszegi am 25.06.2013, 10:56