Day 2 :
Keynote Forum
Anika Staack
MEDICE, Germany
Keynote: Is the current analysis of MAHs of ‘off-label use’ constructive?
Time : 09:30-10:15
Biography:
Anika Staack studied Biology at the University of Marburg (Master degree). She started working as Clinical Research Associate for cancer studies for 1.5 years and switched then into the field of drug safety. For more than 14 years she is working in the area of drug safety/pharmacovigilance and people management. Main areas of research interest are the impact of change in the pharmacovigilance legislation and its influence on quality as well as training. Currently she is working as EU-QPPV for a pharmaceutical company. Further education includes certified business trainer and meditation therapist.
Abstract:
Statement of the Problem: Off-label use is the intentional use of a drug outside the authorized product information. Within the European Union, a recent study revealed that a majority of published studies reporting levels of 20% or higher for the use of off-label medication and more than 55% when looking at the percentage of doctors prescribing off-label. Off-label use might be done due to unavailable authorized products for a specific age group (e.g. off label use in children) or therapeutic groups (e.g.anti-bacterial agents). In the latter, this has an impact on general public health in case of increase in resistance. Off-label use has to be collected by MAHs for further assessment and evaluation. Normally the MAH receives information about off-label use when additional adverse drug reactions happened or via medical enquiries by the treating physicians. The MAHs inform then the reporting physician about the off-label use. Normally, no further data are directly provided by the physician leading to an under-reporting of off-label use and therefore, a lack of appropriate analyzing possibilities and corrective action-taking.Methodology & Theoretical Orientation: In the European database of adverse drug reaction reports the total number of reported cases and the number of reported off-label use was analysed for seven antibiotics. The data include all reports up to
March 2017. Based on feedback from physicians via interviews, nearly 50% prescribed antibiotics off-label.Conclusion & Significance: There is an under-reporting of off-label use in regards to what physicians are reporting on interviews and reporting as cases. This is leading to data of poor quality and evaluability. The analysis process of off-label use should therefore be adopted to reflect the current situation which might lead to a better use of knowledge and current treatment methods of physicians.
Keynote Forum
Flic Gabbay
TranScrip, UK
Keynote: Pharmacovigilance in 2020 -Future horizons and efficiencies in data acquisition, evaluation and risk management
Time : 10:15-11:00
Biography:
Flic was co-founder of TranScrip, a global consultancy who work with many biotech’s and big pharma. She has led many global projects including registration programmes, much of them in TranScrip. In the past, she has held senior positions in Europe and North America including Regional Director of clinical research for Parke Davis and Head of Anti-Infectives, founder of Gabbay Group, a CRO acquired by PPD, She was Founding Chairman of Phico Therapeutics and has also been CEO of two small biotech companies and Chairman of the founding steering group of the UK Faculty of Pharmaceutical Medicine (FPM).
Abstract:
IntraScience is an innovative regulatory, safety and medical services solution for global bio-pharmaceutical companies. IntraScience covers the full spectrum of business process solutions to clinical, regulatory, safety and medical affairs from early drug development to mature products. It uniquely combines the full range of global activities normally provided by large pharmacovigilance and medical affairs CROs plus highly experienced big pharma- and biotech-trained therapeutic and functional staff from Europe and the US. IntraScience seamlessly integrates Indegene and TranScrip staff with client teams for highly cost-effective, top quality deliverables and services, such as end-to-end pharmacovigilance/drug safety. The service will reduce risk and create value through innovation coming from experienced teams of scientists, physicians, software developers, business development experts and project managers.
- Good Pharmacovigilance Practice | Drug Safety | Pharmacovigilance and Risk Management | Regulatory Affairs | Biopharmaceutical Sciences | Adverse Drug Reactions
Location: Forum 15
Chair
Anika Staack
MEDICE, Germany
Co-Chair
Flic Gabbay
TranScrip, UK
Session Introduction
Anika Staack
MEDICE, Germany
Title: How to ensure high quality output in a constantly changing work environment?
Biography:
Anika Staack studied Biology at the University of Marburg (Master degree). She started working as Clinical Research Associate for cancer studies for 1.5 years and switched then into the field of drug safety. For more than 14 years she is working in the area of drug safety/pharmacovigilance and people management. Main areas of research interest are the impact of change in the pharmacovigilance legislation and its influence on quality as well as training. Currently she is working as EU-QPPV for a pharmaceutical company. Further education includes certified business trainer and meditation therapist.
Abstract:
Statement of the Problem: Since 2012, constantly the requirement for pharmacovigilance has changed. The new GVP modules within the EEA provided guidelines, but could still be interpreted differently by competent authorities and MAHs leading to differences in feedback from authorities, between authorities and constantly changing working instructions within companies. Very likely this had an impact on data quality and interpretation of pharmacovigilance data. To ensure high quality data output and performance, constant training is required. This is done usually via annual re-fresher trainings following success control via tests, but lacking efficacy and risk assessments of trainings. New changes in requirements results in ‘best to one’s knowledge’ practice, waiting for feedback from authorities.
Methodology & Theoretical Orientation: Lack of training results in incorrect or missing activities of MAHs. Authorities can find these deficiencies through inspections of MAHs. Therefore, the public pharmacovigilance metrics reports from the MHRA were analyzed to see the changes in the number of findings over time.
Conclusion & Significance: The introduction of the new pharmacovigilance guidelines in 2012 led to another peak of findings in the period April 2013 to March 2014. The current general trend in total numbers is showing a decrease in findings but if this really means increase in data quality cannot be evaluated. It is suggested that following GMP guideline for qualification and validation, a more life-cycle-approach for pharmacovigilance training is chosen which means continuous monitoring of personal qualification, effectiveness of training, and risk management.
Biography:
Mandar is an internationally experienced, Pharmacovigilance professional with significant experience in establishing full-scale Pharmacovigilance systems to cover global operations, providing tailor-made options to clients and delivering advice on compliance within global environments. He has worked in various types of business models like pharmaceutical companies, start-ups, Business Process Operations, Contract Research and Knowledge Processing Organisations. A licensed pharmacist by training with a post-graduate qualification in pharmacology, Mandar has worked for the last 12 years in India, Sweden and UK, where he is currently based.
Abstract:
Biography:
Mario Adel Barsoum is Student in the level 4 in the faculty of pharmacy Ahram-Canadian University. He will be graduated in 2018. He is also Trained in community pharmacy in the year 2014 at Egypt and also attended and finished many courses during 2015-2016 about the first aid, marketing and sales .He got experience in the field of pharmaceutical industrial, marketing and sales through 6 weeks internship at Eva -pharma ,which is one of the biggest companies in Egypt and middle east. He also attended many online courses on Ashp elearning and awarded with certificates. His filed of interests are pharmacovigilance, pharmaceutical research and development, biotechnology.
Abstract:
The topic “overview of Pharmacovigilance” will illustrate some important points about pharmacovigilance which can help us and make the subject more clear, simple and understandable. From this presentation i would like to discuss few basics like definition, introduction, methods of pharmacovigilance, adverse drug reactions, limitation of clinical study, necessity of the topic, who is responsible for pharmacovigilance, what are the responsibilities of the pharmacovigilance, the importance of reporting adverse drug reaction And examples of some drugs were withdrawn due to pharmacovigilance studies. Apart from the above sub topics i will also like to discuss the future of the pharmacovigilance and some suggestions to promote and develop this field.