Commentaries

06 June 2018

Senior Partner, Louise Whitley, reports on DIA Europe 2018

DIA Europe 2018.pngSenior Partner, Louise Whitley, reports on DIA Europe 2018.


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23 October 2017

Reference Safety Information - Are You Up to Date?

Refernce Safety InformationThis is a hot GCP topic and Balall Naeem, an Inspector from MHRA, has been blogging on the issue for MHRA over the last two years. At the recent QPPV forum (DIA) Esteban Herrero-Martinez, Director Regulatory Policy and Intelligence, Abbvie gave a talk on the challenges of the Clinical Trial Reference Safety Information (RSI) from an industry QPPV perspective.


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24 July 2017

Mandar Kelkar presents on 'Efficiency Gain in Business Models for Global Pharmacovigilance: - Automation and Burying the Silos'

Mandar PVPresented by Mandar Kelkar at the 9th International Conference and Exhibition on Pharmacovigilance and Drug Safety on 17-18 July in Munich.


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24 July 2017

Flic Gabbay presents on 'Pharmacovigilance in 2020 - Future Horizons and Efficiencies in Data Acquisition, Evaluation and Risk Management'

Flic PV 2020Presented by Flic Gabbay at the 9th International Conference and Exhibition on Pharmacovigilance and Drug Safety on 17-18 July in Munich.


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30 May 2017

Flic Gabbay presents on 'Future Horizons and Efficiencies in Data Acquisition, Evaluation and Risk Management'

Flic PVPresented by TranScrip's Managing Partner, Flic Gabbay at the 3rd Annual International Conference and Exhibition in Pharmacovigilance, Regulatory Affairs, Risk Management and Clinical Trials in London on 25th May 2017.


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01 March 2017

Future Horizons and Efficiencies in Data Acquisition, Evaluation and Risk Management

IntraScience - 12th PV Slides_Final_01 - Copy (640x480) (140x105).jpgPresented by Ennis Lee at the 12th Pharmacovigilance 2017 Conference, 22nd & 23rd February 2017, London.


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06 October 2016

Benefits and Challenges of Different Drug Safety and PV Business Models: Pilot study to understand Best Practice and innovative methods

Benefits and Challenges of Different Drug Safety and PV Business Models_front page.jpg

Presented by Flic Gabbay at the 3rd Annual Risk Management and Pharmacovigilance Summit, 27th - 29th September 2016, Vienna.


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29 June 2016

Indegene and TranScrip Alliance

On Helix 28Jun2016.pngIndegene and TranScrip Alliance- presented by Flic Gabbay at the One Nucleus On Helix Event, 28th June 2016.


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16 June 2016

Implementing Changes in Pharmacovigilance Regulations

2nd Pharmacovigilance.pngImplementing Changes in Pharmacovigilance Regulations - presented by Dr. Ennis Lee at the 2nd Pharmacovigilance 2016 Conference, 14th June 2016.


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09 June 2016

TranScrip's Sarah Daniels and Flic Gabbay reflect on the recent DIA Euromeeting 2016

DIA Euromeeting post conferencer report_ Final_09Jun2016_Page_1.jpgAs we run up to the DIA 2016 in Philadelphia it is worth reflecting on what happened at the 28th Annual Euromeeting held by DIA in Hamburg in April this year. The overall theme was ‘Do you win by being Innovative?’ As usual there was a packed agenda including 14 themes with almost 1400 registered participants, the majority of whom were from Europe, however there were also attendees from the US and Japan, Brazil and Korea.


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26 February 2016

TranScrip's Maureen Rankine reports on the MHRA GPvP Symposium

transcrips-maureen-rankine-reports-on-the-mhra-gpvp-symposium1.pngOn 6 November 2015, TranScrip attended the annual MHRA Symposium on GPvP (Good Pharmacovigilance Practice) inspections presented by a speaker panel of MHRA Inspectors. The symposium tackled different aspects of the EU pharmacovigilance (PV) legislation, common PV inspection findings and advice on improving internal practices. This symposium is a valuable source of information, and has been particularly important since 2012 with the ongoing implementation of the changes in the EU PV legislation, which continue to present many challenges for marketing authorisation holders (MAHs) and for competent authorities (CAs).


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09 October 2015

MedDRA: Addition of the 27th System Organ Class, by TranScrip's Andy Blackman

MedDRA Commentary 09Oct2015.jpgMedical Dictionary for Regulatory Activities (MedDRA) has been with us now for over 20 years. The International Conference on Harmonisation (ICH) vision for MedDRA is to provide a single standardised international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use.


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10 September 2015

Reports on Medication Errors, by TranScrip's Laura Hiles

Medication Errors Commentary 10Sept2015.pngMedication errors are an important consideration for patient safety and should be easier to prevent than other adverse drug reactions (ADRs). The medication error frequency reported in the literature varies broadly from 2-75% with higher rates in elderly1 or paediatric patients, and in certain treatment settings such as Intensive Care Units or other acute hospital settings.


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29 June 2015

International Conference on Harmonisation (ICH): 25 years on

ICH thumbnail 29Jun2015.jpgWhat are our recollections of the year 1990? During this year there was significant political change and activity within the European Union (EU), and in member states. It was in 1990 that formal negotiations commenced between the European Economic Area (EEA) and the European Free Trade Association (EFTA) to establish the concept of a common European Economic Area (EEA).

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13 May 2015

A brief overview of the Euro DIA 2015 meeting: from a Pharmacovigilance perspective by Senior Partner, Sarah Daniels

A-brief-overview-of-the-Euro-DIA-2015-meeting-from-a-Pharmacovigilance-perspective-Final-13May2015.png13th May 2015: The 27th Annual EuroMeeting was held in sunny, gay Paris from 13-15 April 2015. It marked 5 decades of the Drug Information Association (DIA), 25 years of the International Conference on Harmonisation (ICH) and 20 years of the European Medicines Agency (EMA). As usual, there was a packed agenda with 12 parallel themes to choose from.

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07 January 2015

Risk Minimisation and Measuring Effectiveness – the Evolving Challenge

AJDDP-2-110-Tillotson-G-Antibiotic-development-in-an-era-of-antibiotic-drug-development-acute-skin-infections.png7th January 2015: 2014 saw the publication of the CIOMS report “Practical Approaches to Risk Minimisation for Medicinal Products” and the publication and adoption of the Guideline on Good Pharmacovigilance Practices Module XVI (Risk Minimisation Measures – Revision 1) in response to the completion of the consultation period on the original guideline.

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11 October 2013

PSURS and PBRERS: One Year On, article by Senior Partner, Sarah Daniels

AJDDP-2-110-Tillotson-G-Antibiotic-development-in-an-era-of-antibiotic-drug-development-acute-skin-infections.pngOctober 2013: Since the mid-1980s few novel compounds with unique models of action have been registered, while those which have are generally used for Gram-positive infections.

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30 September 2013

EU Pharmacovigilance Legislation – One Year Later

AJDDP-2-110-Tillotson-G-Antibiotic-development-in-an-era-of-antibiotic-drug-development-acute-skin-infections.png30th September 2013: Since July 2012 we have officially been operating under EU legislation Directive 2010/84/EU amending directive 2001/83/EC for National and Mutual Recognition processes and Regulation (EU) NO 1235/2010 amending regulation (EC) NO 726/2004 for Centralised processes. The legislation was accompanied by the Commission implementing regulation (EU) No 520/2012.

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25 September 2013

Linking the PBRER to the RMP

PBRERs-presentation-Sept-13-C-Knight.pngLinking the PBRER to the RMP, by Colin Knight, September 2013

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26 July 2013

Understanding regulatory referral procedures: Differences between Article 30 and Article 31

AJDDP-2-110-Tillotson-G-Antibiotic-development-in-an-era-of-antibiotic-drug-development-acute-skin-infections.png26th July 2013: Referral procedures for medicines can be implemented for several reasons including safety reasons and the need for harmonisation of prescribing information. Understanding the differences between the referral procedures can help us navigate through the requirements more easily.

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30 April 2013

The new EU-RMP Template: What you need to know

The-new-EU-RMP-Template-what-you-need-to-know-.pngThe new EU Risk Management Plan (RMP) template for submitting the revised Good Vigilance Practices (GVP) RMP document was released by the European Medicines Agency (EMA) at the end of last year. This is now required to be used by companies when submitting RMPs, including both new RMPs that accompany Marketing Authorisation Application (MAA) submissions and updated RMPs for mature products.

19 April 2013

TranScrip Senior Partners lecture “Ethical aspects of Clinical Research in Emerging Markets” at Kings College, London

Sarah-Sree-lecture-at-Kings-College-April-13.jpgOn 17th April Sree Haran and Sarah Daniels, both Senior Partners at TranScrip Partners, participated in the MSc Drug Safety and Ethics module offered by King’s College, London. They ran a session entitled  “Ethical aspects of Clinical Research in Emerging Markets”, delivered plenary lectures and supervised workshops which gave students the opportunity to review and discuss real-life case studies.

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28 November 2012

Human Factors and Transparency, Critical for compliance, even more important for safety

QUASAR-BARQA-Front-page-SD-Article.jpgFaced with the uncertainty and challenges of the new EU pharmacovigilance legislation, it is imperative for the pharmaceutical industry to reflect on existing evidence for ensuring compliance and maintaining safety.

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