Saad Shakir’s Blog2018-10-01T15:04:54+00:00

Saad Shakir’s Blog

MEDS: The DSRU Centre for Methods, Evidence and Regulations in Drug Safety

Saad Shakir writes: A new centre has been established at the DSRU to focus and expand the Unit’s methodological research. The mission of the DSRU is to protect patients from the hazards of medicines. While significant advances have been made in our field in the last 60 years, far more remains to be done. Our aims are to both evaluate and improve on our existing methods, to modify some of our existing approaches and propose new methods. A small team of Physicians, Epidemiologists and Biomedical Scientists will work at MEDS. We will expand the efforts by allocating internal resources, [...]

By |May 9th, 2018|Categories: Saad's Blog|0 Comments

DSRU Consultancy: World class science at a not-for-profit price

Saad Shakir writes: DSRU Consultancy provides consultancy and advice on matters related to Pharmacovigilance, Pharmacoepidemiology, Risk Management and Risk Minimisation. The DSRU consultants are a team of epidemiologists, physicians, biomedical scientists, IT and data management professionals, who provide the consultancy work individually or as a team. We advise all kinds of companies from the some of the largest pharmaceutical companies in the world to medium and small size companies. DSRU Consultancy provides advice in Europe based on the many strengths of our organisation.  These include: Internationally recognised expertise in pharmacovigilance, pharmacoepidemiology, risk management and risk minimisation. In-depth understanding and [...]

By |March 9th, 2018|Categories: Saad's Blog|0 Comments

Measuring the Impact of Pharmacovigilance

Saad Shakir writes: Huge efforts and resources have been allocated to Pharmacovigilance around the world, with enormous progress in the last two decades. Signal Detection, Risk Management and Risk Minimisation are only a few examples of fairly recent developments.  The effects of these and other developments in Pharmacovigilance are real and there are metrics that measure these processes. However the actual impact of Pharmacovigilance on reducing serious morbidity and mortality has not been measured. PRAC, EMA and ENCePP are interested in measuring the impact of pharmacovigilance process. An ENCePP Special Interest Group on Impact has been formed, of which the [...]

By |January 24th, 2018|Categories: Saad's Blog|0 Comments

What are the main objectives of PASS studies for Risk Management?

Saad Shakir writes: In this short blog and video, Saad Shakir outlines the main objectives for PASS studies and describes the characteristics of those who are able to conduct such studies: The objectives of Risk Management Studies are essentially to reduce the uncertainties related to the limitations of pre-marketing data and examine the effects of the different characteristics of real world population who receive medicinal products after marketing. Those who advise on Risk Management Studies and conduct them are required to: Be able to select the most appropriate data source which is capable of answering the study questions. Have [...]

By |March 7th, 2017|Categories: Saad's Blog|0 Comments

Designing studies for risk management plans that are acceptable to European regulators

Saad Shakir addresses the challenges of proposing post-authorisation safety (PAS) studies for risk management that would be approved by regulators: Designing and proposing studies for risk management plans (RMPs) requires more than knowledge about the relevant GVP modules and the template.The process needs strategic thinking that requires understanding of: • The pre-marketing data for the product – more importantly the known unknowns. • Studies proposed in the RMP are essentially to reduce uncertainties about such known unknowns, as well as addressing concerns about the safety when the product is used post-marketing in a population which is likely to be different [...]

By |December 21st, 2016|Categories: Saad's Blog|Comments Off on Designing studies for risk management plans that are acceptable to European regulators

DSRU attends the RCGP Annual Conference in Harrogate

A DSRU team attended the Annual Conference of the Royal College of General Practitioners (RCGP) in Harrogate on 6th – 8th October 2016. The conference welcomes over 1,600 primary care professionals each year and the theme of this year’s conference was “Energising Primary Care”. DSRU medics, Dr Miranda Davies, Dr. Helen Carr and Dr Sandeep Dhanda spoke to many GPs at the DSRU’s busy exhibition booth and also presented a research poster entitled “How is drug safety monitored in UK primary care? Can we be sure that new drugs are safe to prescribe?” Dr Miranda Davies reflected on their experience: [...]

By |October 12th, 2016|Categories: Saad's Blog|0 Comments

Pharmacovigilance Science in the UK and Europe in the years to come

Saad Shakir 19th July 2016 The UK has been a major player in medicines regulations in the EU since the establishment of the CPMP in 1975.  This contribution increased immensely after the single market was established and the EMEA became operational in 1995. Medicines Regulation in the UK is regulated by the Medicines Act 1968 and its related legislation as well as by compliance with many EU directives, regulations and guidelines.  Medicinal Licences in the UK are national, approved by mutual recognition in the EU and are centralised European Licences. The UK scientific and regulatory expertise in the EU [...]

By |July 19th, 2016|Categories: Saad's Blog|0 Comments

A Network of Studies – Risk Management and Risk Minimisation Studies Conducted by a Network of European Countries

Saad Shakir writes: “The 2012 EU pharmacovigilance legislation made it necessary in some cases to conduct a Post Authorisation Safety Study (PASS) in several European countries.  While it is clearly unnecessary to conduct such studies in all 28 member states of the EU, they usually need to be conducted in a number of countries, perhaps four or five.  The EMA’s pharmacovigilance committee, PRAC, and Member State rapporteurs expect some risk management and risk minimisation studies to be conducted in such a way. The DSRU has built up experience of co-ordinating and conducting PASS studies in a network of several [...]

By |January 7th, 2016|Categories: Saad's Blog|0 Comments

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