9^th International Conference and Exhibition on Pharmacovigilance & Drug Safety July 17-18, 2017 Munich, Germany

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. 

Biography:

In 2010, Anna completed her Doctor of Veterinary Medicine in equine internal medicine and cardiology from the Ludwig Maximilian University in Munich, Germany. With over five years of professional experience as a Safety Physician and Drug Safety Manager, Anna currently delivers high quality pharmacovigilance and risk management expertise to Otsuka Novel Products GmbH for multi-drug resistance tuberculosis (MDR-TB). Effective, timely, and benefit risk balanced treatment of MDR-TB poses unique challenges because this disease area involves drug mobilization primarily through compassionate use and expanded access programs. In particular, Anna has contributed significantly to the global medical safety strategy for MDR-TB by setting up, improving and implementing various safety management processes. Besides safety management, her main area of interest has always been medical review, including process and content wise efficient and accurate implementation on global level. Her interests include travelling, golfing, skiing and riding. 

Abstract:

Case quality is founded on accurate medical review and this quality ultimately translates into all subsequent activities, i.e. aggregate reports, signal management and all other product safety activities.

Accurate medical review starts with source data verification, triage – preliminary medical review, and data entry (relevant laboratory data, medical history etc. to be medically justified and entered, correct AE coding).

Ultimately these activities translate into a justified medical review statement which is disclosing the rationale why the adverse event is assessed as related or not related.

Biography:

Temitope Oyeneye completed her Graduation at Olabisi Onabanjo University and internship at Lagos University Teaching Hospital in Lagos, Nigeria. Presently, she is working as Pharmacist at Drug Consult Pharmacy, Nigeria. She has years of experience in interpreting a prescription and administration of pharmaceutical drugs at both government hospital and private corporate pharmacy stores.

Abstract:

The future of achievable pharmacovigilance depends solemnly on spontaneous adverse drug reaction (ADR). ADR reporting with yellow cards has tremendously improved pharmacovigilance of drugs in many developed countries and its use is advocated by the World Health Organization (WHO). ADR reporting among health care workers in Nigerian tertiary institutions is at a very low practice. A total of 180 questionnaires were distributed to different healthcare practitioners (HCPs) in three tertiary hospitals: The Federal Neuro-Psychiatric Hospital, Yaba; Lagos University Teaching Hospital, Idi-Araba and; National Orthopaedic Hospital, Igbobi all in Lagos Nigeria. The questionnaire sought the demographics of the HCPs, their knowledge and education on pharmacovigilance, practice and attitude to pharmacovigilance, the factors that they perceived may influence pharmacovigilance practice and suggestions on the possible ways to improve ADR reporting. The result gave 95.6% response rate. A majority of the respondents showed an appreciable knowledge of PV. Education and training was the most recognized means of improving ADR reporting. In conclusion, pharmacovigilance practice among the Nigerian health care professional proves to be inefficient and lack a proper data base documentation. Though, there has been a slight improvement when compared to previous studies, social workers and all sectors of the health care system needs to be involved. Government needs to include private hospitals, retails dispensaries, providers and traditional medicine. More awareness should be created on the yellow card reporting scheme. Social workers and continuous education, training and integration of ADR reporting into hospital activities would likely improve reporting and PV practice in general. 

Biography:

Abstract:

Statement of the Problem: No therapies currently exist for intellectual disability in Down syndrome (DS), a genetic disorder caused by triplication of chromosome 21. Intellectual disability is attributable to a severe reduction of neurogenesis that can be traced back to prenatal life stages. Accumulating evidence suggests that the triplicated gene APP (amyloid precursor protein) may be a particularly crucial determinant of neurogenesis alterations, because the AICD fragment of APP inhibits the mitogenic SHH pathway by increasing the expression levels of PTCH1, the inhibitory receptor of the SHH pathway. Since AICD derives from the cleavage operated by APP gamma-secretase, it may be envisaged that inhibitors of gamma-secretase may reduce excessive AICD levels with consequent restoration of the SHH pathway and, thus, neurogenesis.

Methodology & Theoretical Orientation: We used the Ts65Dn mouse model of DS in order to establish whether neonatal treatment with an inhibitor of gamma secretase (ELND006) reduces AICD levels and restores neurogenesis in the hippocampus, a region that largely develops postnatally in rodents and plays a crucial role in learning and memory.

Findings: We found that inhibition of gamma-secretase normalized the levels of AICD and PTCH1. This effect was accompanied by full restoration of hippocampal neurogenesis and total granule cell number. Treatment additionally restored neurite and synapse development and hippocampal functional connectivity.

Conclusion & Significance: Results show that the APP/AICD system may be a key target for the improvement of neurodevelopmental alterations in DS. The inhibitor of gamma secretase used in our study, however, was not free of side effects. A challenging issue is now the creation of new molecules that, while selectively inhibiting APP gamma-secretase, are truly devoid of side effects. This achievement may have an important translational impact for DS and other APP-linked brain disorders.

Biography:

Parminder Kaur is a regulatory affairs and PV expert with 19 years of recognized global expertise in a broad range of therapy areas. She has played a major role in setting the in-house RA and PV systems in compliance with the European regulations at various companies. She has provided strategic input for regulatory matters regarding product development aimed for EU launch, ranging from innovative product development incl. gene therapies, biologicals and biosimilars, vaccine and generic product approval as well as orphan designations and early access to unapproved medicines. She has also been highly involved in the pharmacovigilance set-up at various companies. She has played a major role in setting the QA systems in compliance with the European legislation at various companies; assisted various companies during inspections and audits conducted by EU Regulatory Authorities. She is acting as EU-QPPV and deputy QPPV for some companies. Currently, she is running her own consulting firm - RegPak BioPharma Consulting, Netherlands.

Abstract:

Effective pharmacovigilance requires a set of rules, operating procedures, and practices that must be followed to ensure the quality and integrity of marketed product. Good Pharmacovigilance Practice (GVP) is a quality standard for monitoring the safety of medicines and if necessary, taking action to reduce the risks and increase the benefits of medicines. It ensures the detection, collection, assessment, understanding, and prevention of adverse effects with medicinal products. As per GVP, every Marketing Authorization Holder (MAH) must ensure that they have an adequate and effective quality system for monitoring the medicines they have license for. It is expected that MAH: maintains a pharmacovigilance system; document all actions they take concerning safety reporting and signal detection and; have enough competent, appropriately qualified and trained staff to work the system. In order to gain a greater understanding of GVP requirements, this session will cover GVP modules I to XVI covering major pharmacovigilance processes which should be implemented by the pharma companies doing business in EU.