Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 15th International Conference and Exhibition on Pharmacovigilance & Drug Safety Paris, France.

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Scientific Program Day 1

Day 1 :

Keynote Forum

Mayada Alkhakany

Boehringer Ingelheim, International Society of Pharmacovigilance/ISoP, Germany

Keynote: Patient Engagement during COVID 19

Time : 10:30 - 11:00

Conference Series pharmacovigilance 2022 International Conference Keynote Speaker Mayada Alkhakany photo
Biography:

Dr. Mayada Alkhakany has more than 15 years of experience working within various sectors of the pharmaceutical industry having worked across a range of key areas including clinical operation, medical affairs, and pharmacovigilance functions.

She was the head of pharmacovigilance in Middle East, Turkey, and Africa (2014-2019) in Boehringer Ingelheim. She was an associate director of pharmacovigilance in Merck Sharp & Dome (2010-2014). She’s pharmacovigilance, policy making and leadership consultant.

Dr. Mayada is a member of ISoP (International Society of Pharmacovigilance), founder and Chair of ISoP patient engagement group.  Co-founder and ex-president of ISoP Middle East chapter (2015-2020). She was the chair of local organizing committee of the annual meeting of ISoP 2021. She conducted many training programs under the umbrella of ISoP Middle East Chapter and in collaboration with Arab Health Authorities. She has been invited as a speaker in many conferences both international and regional.

 

Abstract:

WHO declared COVID 19 as a pandemic on March 11 2020. With more than 174 million confirmed cases and 3.6 death cases reported in June 2021. The pandemic has had a major impact on the healthcare system and on the life of everyone in the world. All the traditional methods and tools had been changed to overcome this world crisis. Thus, patient engagement has been impacted dramatically. i.e , the engagement between healthcare providers and patients or caregivers have changed from clinic visit to telemedicine, and hospitals have implemented restrictions on inpatient’s visit. Additionally, much of the research on the different disease areas had been postponed prioritizing the treatment of the COVID 19. Most of the patient organization and activities were put on hold. 

Different types of engagement have been introduced which have had positive and negative impacts on the patient in the treatment journey. The healthcare system was not well prepared to handle the challenges involving the patients during the pandemic Although, the healthcare providers along with technology companies and pharmaceutical companies tried to react and take an action to ensure that the patients will be able to receive a minimum care and overcome any challenges with the supply  of medicines

 

Keynote Forum

Joan D Souza

EMWA Volunteer

Keynote: GVP module V, GVP module XVI, and GVP module XVI addendums

Time : 10:00 - 10:30

Conference Series pharmacovigilance 2022 International Conference Keynote Speaker Joan D Souza photo
Biography:

Joan D’souza is a freelance pharmacovigilance and medical writer also; she currently works as a Regulatory Intelligence Expert and Item Writer at the Institute of Pharmacovigilance. She is the Chair of Switzerland and Austria International Society of Pharmacovigilance (ISoP) chapters. She is also very active at different Special Interest Groups (SIGs) at ISoP such as the Risk communication, Geriatric, Medical Devices, and Ecopharmacovigilance SIGs. She is also active at the European Medical Writers Association (EMWA) Pharmacovigilance and the Medical Devices SIGs.

 

Abstract:

At the end of a clinical trial, we may know about the drug's efficacy, but unfortunately, we know very little related to the drug's safety profile. Inclusion/exclusion criteria restrict the patient population to limited clinical trial participants. Also, many drugs have a long latency; drugs may develop their safety profile after a very long duration. Nevertheless, the benefit-risk balance of a particular medicinal product must always remain positive.

RMP is a detailed description of the risk management system of a drug. The RMP is prepared whenever there is a significant change to the benefit-risk balance of a drug or at the time of approval of a new drug. RMP identifies, characterizes, and minimises a medicinal product's risk. It includes only important identified and potential risks and missing information. RMP includes three major sections; safety specification, pharmacovigilance plan, and risk minimization measures. Good Pharmacovigilance Practices (GVP module V) entail RMP and must be read along with GVP module XVI- Risk minimisation measures and GVP module XVI addendum I- educational materials. Addendum I provide further guidance to the health care authorities and the national competent authorities to support the assessment of educational materials about format and content. GVP module XVI addendum II- Risk minimisation measures: selection of tools and effectiveness indicators, provide additional guidance to marketing authorisation holders and competent authorities on data sources and methodologies for monitoring outcomes of risk minimisation measures. GVP module XVI addendum III- Risk minimisation measures: pregnancy prevention programme and other pregnancy-specific risk minimisation measures aim to minimise exposure to a medicinal product during pregnancy. GVP module V and GVP module XVI and its various addendums provide a complete profile of the risk management system for all safety concerns. Both: GVP module XVI addendum II and III are still drafts for public consultation.

 

Keynote Forum

Rimma Battalova

QPPV Arterium Corporation, Ukraine

Keynote: The global issues of ensuring the continuity and efficiency of the performing pharmacovigilance processes by Marketing Authorization Holders (MAH) during mortal low, based on the experience of Ukraine since 24.02.2022
Conference Series pharmacovigilance 2022 International Conference Keynote Speaker Rimma Battalova photo
Biography:

Rimma Battalova, MD, MBA, QPPV Arterium Corporation Kyiv, Ukraine MD, National Medical University, 1999 МВА, 2007. She has more than 20 years experienced in pharmaceutical area. For over 12 years as QPPV take an active part as QPPV in maintaining and developing PhV System in Arterium Corporation, also as a member of working groups from MAHs took an active part in harmonization Ukrainian PhV legislation with EU standards. She is the Head of Subcommittee of Pharmacovigilance in European Business Association (Ukraine), certificated business trainer of PhV, Guest–lecturer from MAH in Medical and Biotechnological Universities of Ukraine.

 

Abstract:

In my report, as a QPPV, I would like to share the experience of functioning PhV system in Ukrainian MAH as one of the market leader. Also as well I would like to highlight the key points, challenges, solutions are faced during the performing Pharmacovigilance processes by Arterium Corporation since the beginning of a military invasion of Ukraine by the Russian Federation.

The company's motto is- "To be closer to the people”, in PhV language it means- to ensure the appropriate level of safety for each product.

02/24/2022 - the date that brought new challenges for all MAHs, who operate on the Ukrainian market, such as:

  • showed their breaking point of the current Pharmacovigilance system,
  • identified new weak links and development zones for the MAH, which could not be predicted in peacetime,
  • identified for managers what tools and approaches were effective, which have made contribution for ensuring the sustainability of the system,
  • We were able to identify vulnerable points in matters of ensuring the safety of the Ukrainian applicant's drugs in foreign markets of presence, on which it is necessary to work together in nearest future with the Global pharmaceutical community, and develop approaches and rules for further actions in critical situations.
  • In practice, we have faced and experienced in real condition the principles that at critical moments you are at the level of basic training, and it is important to understand this and continue to maintain a sufficient level of professionalism and managerial competencies.

Summary

The author does not state the conclusion, but highlights the intermediate results according to the assessment:

  • the readiness of System
  • the detection of the margin of safety
  • the ability to respond quickly

This, in turn, will allow us in the future to:

  • stabilize and continue uninterrupted operation
  • identify weak links and areas of development
  • develop additional procedures within the system
  • raise Global issues of patient safety to a higher level of communication in the industry in order to share experience and further develop joint approaches and solutions

 

Keynote Forum

Antonio Steardo

Pharmaceutical and Professional Consultant, Italy

Keynote: Products containing free cannabis, appropriate pharmacovigilance asset to a better quality of everyday life through better safety and efficacy
Conference Series pharmacovigilance 2022 International Conference Keynote Speaker Antonio Steardo photo
Biography:

Antonio Steardo specialized in Pharmacology and graduated in Pharmacy and Pharmaceutical Chemistry. He now has more than twenty years of experience in the pharmaceutical products sector since elementary school; his personal curiosity for chemistry manifested itself during games and continued with lectures at the department of science at the University of Salerno from the age of eight years old. Therefore, during the cycle of studies, he prefers biochemistry and biochemistry of drug action, graduating in July 2007 with a thesis on the functioning of the Endocannabinoid system in Alzheimer’s disease in Pharmacology. Following the beginning of his pharmaceutical chemistry studies, he stopped for a competition as a postgraduate in Pharmacology at the University of Rome La Sapienza in July 2014. Continuing his personal professional development and skills, he enrolled in continuing professional training at the University of Oxford to follow courses on Experimental and Translation Therapy and on Medical Research. His desire to improve leads him to attend international conferences and seminars to this day.

 

Abstract:

Following decades of research, the retrieval of components in Cannabis has made feasible the study of several psychotropic and non-psychotropic compounds that this herb and its variants contain. Useful new non-medical products have appeared on the market and this presentation aims to assess the pharmacological impact these on a wide population of consumers.

Nowadays, a broad variety of cosmetics, food, supplements, and many other products attract wide-ranging consumption on the market.

This presentation aims to discuss and introduce ideas on a better perspective on Pharmacovigilance to control properly the broad consumption of new-fashionable and new-taste products. Indeed, passed collected data can delineate a strategy for a correct prevision from collected knowledge. It would be Pharmacovigilance management. Improve the management of sometimes harmful side effects and represents a step forward in public health.

The aim of this presentation is to convince that by an appropriate Pharmacovigilance asset and by new data analysis strategy, it is possible to obtain an innovative guide to correct use. Safety and efficacy would improve the general quality of life, as these products are readily available on the market, throughout all pharmacovigilance connected skills.

 

Keynote Forum

Nagalakshmi Ramamoorthi

Safety Writer, United Kingdom

Keynote: Over the Counter Drugs and Drug Safety
Conference Series pharmacovigilance 2022 International Conference Keynote Speaker Nagalakshmi Ramamoorthi photo
Biography:

Nagalakshmi Ramamoorthi is a physician by training, having graduated in 2012 with a MD degree in Pharmacology. She has experience working as a Senior Medical Affairs Advisor and an investigator for conducting several phase-1 clinical trials. Her experience includes conducting clinical studies, respond to questions from health authorities, manage consumer queries using healthcare databases, performing scientific literature searches, writing systematic literature review reports, analyze and comprehend complex safety data and using this skill to produce high quality, scientifically accurate and balanced documents covering a wide range of health and hygiene products.

Abstract:

Introduction: Today, there has been a constant increase in the self-medication phenomenon among patientsdue to the large availability of drugs available over the counter. Overuse can lead to misuse or abuse of OTC medicines and can cause addiction and dependency.
 
Incidence of OTC abuse: OTC medicine abuse was identified in many countries. A Comprehensive search of international empirical and review literature between 1990-2011 identified five key medicine classes i.e., codeine/opioid based cough medicines, non-opioid based medicines, sedative antihistamines, decongestants,
and laxatives.
 
Harms associated with OTC abuse: A range of problems and harms associated with OTC medicine abuse were identified and these comprised three broad categories such as direct harms associated with the primary ingredient, physiological harms due to the adverse effects of another active ingredient, economic costs, and effects on personal and social life. An observational study in Finland identified various drug related problems (DRP) involving fifty-two community pharmacies using a questionnaire survey. They documented 339 drug related problems and to resolve them 641 pharmacy interventions emerged.
 
Interventions and support: Pharmacists play a major role in preventing DRP associated with OTC drugs thereby decreasing adverse events and drug-drug reactions. Most common suggested interventions include providing training to pharmacist to increase awareness among both public and health care professionals, counselling consumers to abuse potential of products, advising them to contact their doctor when needed, limiting advertisements, and making bold warnings on packets etc. OTC control varies across the globe and stricter in Poland, Germany, Austria, France, and Sweden.
 
Addressing the evidence gap and Conclusion: Robust methodologies should be used to select a representative cohort of users to answer safety related questions. Such survey data are often got unnoticed by sponsors. Since they to help quantify the benefit of OTC status it should be published in the literature. Training and practice ofpharmacy-based interventions should be encouraged to avoid the harms associated with OTC abuse.

Keynote Forum

William DuMouchel

Oracle Health Sciences, USA

Keynote: Signaling COVID-19 vaccine adverse events
Conference Series pharmacovigilance 2022 International Conference Keynote Speaker William DuMouchel photo
Biography:

Abstract:

Introduction: Statistical signal detection is a crucial tool for rapidly identifying potential risks associated with pharmaceutical products. The unprecedented environment created by the coronavirus disease 2019 (COVID-19) pandemic for vaccine surveillance predisposes commonly applied Signal detection methodologies to a statistical issue called the masking effect, in which signals for a vaccine of interest are hidden by the presence of other reported vaccines. This masking effect may in turn limit or delay our understanding of the risks associated with new and established vaccines.
 
Objective: The aim is to investigate the problem of masking in the context of COVID-19 vaccine signal detection, assessing its impact, extent, and root causes.
 
Methods: Based on data underlying the Vaccine Adverse Event Reporting System, three commonly applied statistical signal detection methodologies, and a more advanced regression-based methodology, we investigate the temporal evolution of signals corresponding to live largely recognized adverse and two potentially new adverse events.
 
Results: The results demonstrate that signals of adverse events related to COVID- 19 vaccines may be undetected or delayed due to masking when generated by methodologies currently utilized by pharmacovigilance organizations, and that a class of advanced  methodologies can partially alleviate the problem. The results indicate that while masking is rare relative to all possible statistical associations, it is much more likely to in COVID-19 vaccine signaling, and that its extent, direction, impact, and roots are not static, hut rather changing in accordance with the changing nature of data.
 
Conclusion: Masking is an addressable problem that merits careful consideration, especially in situations such as COVID-19 vaccine safety surveillance and other emergency use authorization products.

Keynote Forum

Peter Yamoah

University of Health and Allied Sciences, Ghana

Keynote: Adverse events following immunization associated with coronavirus disease 2019 (COVID-19) vaccines: A descriptive analysis from VigiAccess
Biography:

Abstract:

Statement of the problem: Despite the rigour of pre-marketing vaccine trials, the safety of new vaccines is not completely understood from pre-authorization clinical trial data as these trials are conducted in controlled settings different from settings of real-world use. Consequently, such data have limitations in their postmarket applicability. It is therefore imperative to report Adverse Events Following Immunization (AEFI) after regulatory approval of vaccines for a better understanding of their safety profiles. This study assessed AEFIs reported on COVID-19 vaccines and determined AEFI reporting trends across all continents of the world in the World Health Organization (WHO) open access pharmacovigilance database, VigiAccess.
 
Methodology & theoretical orientation: The study was cross-sectional quantitative in design. VigiAccess was searched on November 10, 2021 for reported adverse events following the introduction of COVID-19 vaccines. After entering the search term, “COVID-19 vaccines” in VigiAccess, AEFIs associated with 9 approved brands of COVID-19 vaccines had been documented in the database. Data were captured among age groups, sex and continents of the world and analysed using Statistical Package for Social Sciences (SPSS) version 25.
 
Findings: Overall, 2,457,386 AEFIs had been reported in VigiAccess at the time of the search. The top 10 commonly reported AEFI types with their percentage of the total number of AEFIs were as follows: general disorders and vaccine administrative site conditions (1,481,549, 60.1%), nervous system disorders (1,046,928, 42.6%), musculoskeletal and connective tissue disorders (704,657, 28.6%), gastrointestinal disorders (495,997,20.2%), investigations with undesirable outcomes (341,677, 13.9%), skin and subcutaneous tissue disorders (335,932, 13.6%), respiratory, thoracic and mediastinal disorders (262,158, 10.6%), infections and infestations (180,873, 7.3%), vascular disorders (132,533, 5.3%) and injury, poisoning and procedural complications (122,519, 5%). No causal associations could be established between the vaccines and the AEFIs. It is recommended that the public accessing VigiAccess data should be made aware of the fact that it is impossible to do causality assessment with data in VigiAccess in order not to falsely attribute AEFIs to COVID-19 vaccines when assessing the database.

 

Keynote Forum

Eman Alghamdi

Saudi Food and Drug Authority, Saudi Arabia

Keynote: Active post-marketing drug surveillance for several adverse events: Saudi food & drug authority experience
Biography:

Abstract:

Post-marketing drug surveillance for Adverse Drug Events (ADEs) has typically relied on passive spontaneous reporting. Recently, SFDA have turned their attention to more preemptive approaches that use existing data for active surveillance. Thus, a post-marketing surveillance program was implemented to evaluate the safety of Monoclonal Antibodies Diseases Modifying Agents (MABs). The objective of this presentation is to evaluate the safety of (Ocrelizumab, Natalizumab, Rituximab, and Alemtuzumab) in multiple sclerosis patients.
 
Methodology & theoretical orientation: A retrospective cohort study using real-world data from a tertiary hospital in Riyadh, Saudi Arabia was performed to detect safety profile of MAB in patients with MS. The Study included treated patients with one of the MABs from January 2015 to December 2021. The objectives were
to identify Adverse Drug Event (ADEs) associated with the use of MABs. The Medical Dictionary for Drug Regulatory Affairs (MedDRA) was used to classify ADEs according to the System Organ Classification (SOC) and the Preferred Term (PT). ADEs were classified based on the seriousness, and expectedness, according to SFDA guidelines on Good pharmacovigilance Practices. Descriptive analyses were performed, including frequency/percentages for categorical variables and mean or median for continuous variables. All ADEs were crosschecked listing with local Summary Product Characteristics (SPC), United States Food and Drug Administration (FDA) drug label, and European SPC to identify new safety signals using the scheme illustrated in [Figure 1].
 
Findings: 214 patient’s records met the eligibility criteria, ocrelizumab (144), natalizumab (46), rituximab (19), and alemtuzumab (4). Their socio-demographic characteristics are summarized in [Table 1].
 
Conclusion: This study shows an acceptable safety profile of MABs in MS patients. Besides, it reports data that identified new safety signals not previously addressed in the local & international product information label, which need further investigation. Thus, there are strong motives for implementing similar programs to provide
data for updated risk–benefit analyses.

 

Keynote Forum

Meghana Nadella

JSS University, India

Keynote: Diclofenac adverse effect after its Oral and IV administration: Case series
Biography:

Abstract:

Diclofenac is a most commonly used NSAID for pain and inflammatory management. Diclofenac has an equipotential inhibitory action on Cyclooxygenase (COX) 1 and 2 enzymes, there by hindering prostaglandin production. In a hospital setting it is administered through Intramuscular (IM), Intravenous (IV), transdermal, oral and rectal routes. Although, the medication is considered as an appropriate option to treat post-operative pain, it is associated with morbid syndromes like Kounis and Nicolau along with gastrointestinal, hepatic, neurological, renal and respiratory adverse effects. The immunological adverse effects are comparatively underreported and among those reported anaphylactic reactions associated with IM and rectal routes of administration of diclofenac are common, whereas, IV and oral route diclofenac allergies are rare. The case report series of diclofenac allergy by IV and oral diclofenac administration are reported here. In either cases patient developed drug induced hypersensitivity reaction as soon as the drug administered, causality assessment is performed in both the cases and concluded that the reaction was moderate and definitely preventable in one as the patient informed of a similar reaction in past after diclofenac injection and in the other case the causality assessment stated the reaction was moderate and not preventable as patient has no past history. Thus, our paper concludes by saying adverse effects of diclofenac include angioedema usually quite self-limiting, though it is proven to be fatal at times. Thus, the condition should be identified early and the offending agent should be removed. Corticosteroids antihistamines can be useful in management. Healthcare professionals should keep in mind the possible adverse reactions of the diclofenac and the patient should be well enquired about reaction history or to be informed regarding the adverse reaction caused by the drug before prescribing and dispensing it.