Dublin, Feb. 12, 2020 (GLOBE NEWSWIRE) -- The "Pharmacovigilance World 2020" conference has been added to ResearchAndMarkets.com's offering.

Pharmacovigilance World 2020 will provide a platform for the participants to discuss, share and stay updated with present state of affairs in Pharmacovigilance and Drug Safety, and contribute to the public health. It will also allow all its participants to interact with the experts, discuss the various developments, challenges faced and innovations in the field.

The conference will bring-forth the participants and the representatives from various fields of pharmacovigilance and drug safety under a common umbrella and will provide them an opportunity to network with various industry professionals including pharmaceuticals, biologics, devices, CROs and PV service providers.

With the augmented incidence of diseases, and the non-medical use of prescription drugs, the incidence of drug abuse has increased enormously in the recent years, which is apparent with the excess documentation of adversities and drug toxicities.

In this context, the drug safety and pharmacovigilance has emerged as a dynamic clinical and scientific discipline to provide adequate information and ensure health safety by the joint interaction of doctors and patients in choosing appropriate treatment method and drug. However, evidences suggest though avoidable, the adverse drug reactions (ADRs) to medicines continue to be the bigger life risk.

In England, ADR was responsible for up to 6% of hospital admissions, carrying a mortality of 2% and costing the NHS 466 million per annum (654 million, US$ 602 million) in 2004. In some countries, ADR is ranked among the top 10 leading cause of mortality. The concept of drug safety and pharmacovigilance has evolved considerably and is highly necessary to keep the severity of ADR under check. In order to prevent or to reduce harm to patients and improve public health, it is vital to develop and practice mechanisms for evaluating and monitoring the safety of medicines in clinical use. Pharmacovigilance brief the potential implications of such trends on the evolution of the science.

However, these days it is confronting issues to develop a better health care system in this global pitch. Some of the major challenges include globalization, web-based sales and information, broader safety concerns, public health versus pharmaceutical industry economic growth, monitoring of established products, developing and emerging countries, attitudes and perceptions to benefit and harm, outcomes and impact, etc.

Key Highlights

• Pharmacovigilance and globalization
• Women and child health care medicines and pharmacovigilance
• Patient-centric approaches in PV
• Pharmacovigilance legislation and regulations
• Harmonization and pharmacovigilance
• Advanced therapeutic techniques and pharmacovigilance
• Pharmacovigilance and data management and eudravigilance
• Post-marketing surveillance in pharmacovigilance
• PV regulations and challenges
• Benefit-risk management strategies
• Risk management and minimization
• Adverse drug reactions reporting
• Signal detection and post-authorization safety
• Good Pharmacovigilance Practices
• Innovative approaches to drug safety
• Strategies to improve PV
• Real-World Evidence in PV
• Big data and AI in pharmacovigilance
• Pharmacovigilance Monitoring and automation in Social media
• Other emerging technologies in PV

Agenda

DAY 1

08:30 - Registration & Refreshments

08:50 - Chairperson's opening remarks

09:00 - Morning Keynote: Pharmacovigilance in the Elderly - The importance of monitoring adverse drug reactions in elderly patients

09:30 - Morning Keynote: Pharmacovigilance of women and child health care medicines and its challenges

• Pharmacovigilance - significance, scope and challenges
• Personalized medicines
• Safe drug use: Adverse drug reactions, Adverse-drug interactions, monitoring

10:00 - An Integrated care: Effective Implementation of vigilances systems

• Separated vigilance systems can lead to the emergence of divergence in terms, definitions, variety of reporting forms and methods and the build of specific databases where cross analysis is no more possible.
• To be more proactive and innovative in PV and to ensure that emerging problems are promptly recognized and solutions are effectively communicated
• This integrated approach is very useful, especially for emerging countries to strengthen regulatory processes and to promote high standards of product vigilance for the protection of the health and safety of Citizens.

10:30 - Morning Coffee/Tea & Networking

Legislation & Regulatory update

10:50 - PV regulations and challenges and how to accommodate all the various national requirements in a global organization

11:20 - International harmonization and drug regulatory requirement

• Sales, information and knowledge of consumers
• Awareness, generic names, reduction of medication errors in private clinics
• Industrial association

Inspection, Quality & Compliance

11:50 - Reason, Scope and Significance of establishing good PV system

• Quality system within organizations
• Critical PV process
• Training
• Risk management

12:20 - GxP inspections of PV system, scope, trends and challenges

12:50 - Networking & Luncheon

13:30 - Ensuring Quality Oversight in Pharmacovigilance

Advanced therapy medicinal products (ATMPs) and PV

14:00 - Advanced therapeutic techniques and pharmacovigilance

• Advanced therapeutic techniques and pharmacovigilance
• Challenges related with monitoring and safety
• Benefit-risk assessment of ATMP

14:30 - Major developments in regulatory framework

• The future of gene therapy, stem-cell therapy, and tissue engineering
• EU guidelines and updates - Good Manufacturing Practices for ATMPs

15:00 - Afternoon Tea/Coffee

15:20 - Interactive Roundtable Discussion

• All attendees will have a great opportunity to discuss a selection of the most interesting topics addressed during the conference in small groups with their peers.
• Every table will nominate a head of the table, who will summarize the topic discussed, present the main puzzles and questions posed.

Strategies and Outsourcing

15:50 - Strategies to improve Pharmacovigilance

16:20 - Panel discussion: with session speakers and interaction with the floor

PV Outsourcing: Challenges and Opportunities

• Economy
• PV Quality assurance
• post-authorization safety studies
• Building partnerships
• Identifying the key areas for outsourcing
• The main challenges faced and impact of new legislation
• Core competencies, activities-database, follow-up studies, case-studies, etc.

16:50 - Chairperson's closing remarks

17:00 - Networking Drinks Session

DAY 2

08:30 - Registration & Refreshments

08:50 - Chairperson's opening remarks

09:00 - Keynote Case Study: Interim results of a PASS on ospemifene in postmenopausal women with Vulvar and Vaginal Atrophy (VVA)

PSMF, Eudravigilance & Data Management

09:30 - PSMF - Pharmacovigilance system master file

• PSMF summary design, role of QPPV and managing audits
• Responsibilities of stakeholders.
• Accessibility of PSMF and Transparency and ensuring compliance
• Challenges in the managing data collection, audit information and documenting changes in logbooks, transferring information to license partners or third parties.

10:00 - Eudravigilance - how well has it been integrated and accepted by organizations

• Improvement in data analysis and exchange of individual case safety reports (ICSRs) between EMA, and various parties.
• The new and improved of Eudravigilance
• Connecting EMA with other regulatory bodies using Eudravigilance

10:30 - Morning Coffee/Tea & Discussion

Postmarketing surveillance & drug safety

10:50 - Structured benefit risk in the post-marketing surveillance in pharmacovigilance

11:20 - PMS and globalization

• Limitations of premarketing clinical trials
• Adhering to various national and international regulatory bodies
• Adverse event reports, role of FDA/ CDER/ DPV/ FDA Adverse Event Reporting System (FAERS)
• Type of post-marketing surveillance - Role of MedWatch or similar

Adverse Event Reporting and Signal Detection

11:50 - Pharmacokinetics, Pharmacodynamics studies to minimize adverse event
Assessment and categorization - adverse event reporting clinical trial, pre-/post-marketing pharmacovigilance reporting timelines

12:20 - An industrial perspective: Post-marketing Signal Detection and management

• Present Drug safety signal detection systems and tools and what do they lack
• Emerging techniques and tools in the detection and management of signals
• Sources for identifying safety signals

12:50 - Networking & Luncheon

Risk Management and Risk Minimisation

13:30 - Risk Minimization and Management

• Assessment with comprehensive data quality
• Compliant safety system (GxP compliant, inspection-ready system)
• Safety signals, effective trials, strategic risk assessment decisions

14:00 - Minimizing risk and innovative approaches for prediction such as the use of safety biomarkers and pharmacogenetics

Next-Gen Technologies & Data Management

14:30 - Pharmacovigilance Monitoring and automation in Social media

15:00 - Afternoon Tea/Coffee

15:20 - Impact of Machine learning and artificial intelligence in PV

• Ever expanding data and its safety
• Importance and application of AI
• Improving speed, accuracy and reliability using AI

15:50 - Real-World Evidence for Assessing Drug Safety

16:20 - Improving patient involvement and wearables

• Role of internet/ communication techniques, advertisement
• Illegal effects
• Post-market surveillance of devices
• Therapeutic good administration
• Safety management

16:50 - Panel Discussion: Innovation and the future of Pharmacovigilance

• Importance of bringing patients on board
• The need for patient database and effective communication
• Emerging technologies, digitization and social platform
• Benefits of digital technology and regulatory hurdles

17:20 - Chairperson's closing remarks

For more information about this conference visit https://www.researchandmarkets.com/r/qlpugx

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