About 16th Pharmacovigilance 2018

16th Pharmacovigilance 2018 – “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management”, 02nd – 04th Oct 2018, DoubleTree Suites By Hilton Boston, Cambridge, Massachusetts, USA.

16th Pharmacovigilance 2018 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.

The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry experiences.

This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organizations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing PV requirements, and to improve their organizations’ compliance with PV requirements.

Also, it can help you control your product’s lifecycle, your patient’s trust, and your revenue.

Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting Pv development.

WHO SHOULD ATTEND:
CEO’s, CTO’s, CIO’s, Presidents, VPs, Directors, Heads, Managers, Scientific Advisors, Consultants of:
Pharmacovigilance, Pharmacoepidemiology, Pharmacogenomics, Drug/Product Safety, Drug Development, Information and Clinical Data Management, Clinical Pharmacology, Clinical Safety, Periodical safety update Reports, Risk Management, Research & Development, Quality Assurance, Patient Safety, Signal Detection, Safety Surveillance, Outcomes Research, Data Analysis, Epidemiology, Medical Affairs, Regulatory Affairs and Compliance, Information technology, Sales and Marketing.

KEY THEMES:
• Pharmacovigilance in the US: What comes next for the industry?
• Recent developments – legislation, policies, systems, technology, communication strategies and best practice in PV
• Optimising the overall PV ecosystem – Challenges and Opportunities
• Why does pharmacovigilance sometimes fail and where
could the fault lie?
• Pharmacovigilance and healthcare system
• Technology Impact – Cloud – Big data – Analytics – AI – Machine learning
• Updates to PSUR, PBRERs, DSUR, PASS
• Good Clinical Practices and Good Pharmacovigilance practices
• Future of outsourced phase I, II and III trials and post-marketing studies
• Data quality management and analysis – analyzing the new guidelines
• Strategies to improve clinical trials and PV
• Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
• Patient centric approach to help improve patient safety
• Outsourcing activities – Choosing your right vendor and setting the path right
• PV Audit & inspections – preparation, implementation and lessons to be learnt
• Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
• Current regulations and guidelines – USA, EU and RoW
• The developing regulatory framework in advanced and developing markets
• Be part of a major networking opportunity