The UK has been a major player in medicines regulations in the EU since the establishment of the CPMP in 1975. This contribution increased immensely after the single market was established and the EMEA became operational in 1995.By 2020, the size of the global pharmaceutical market is anticipated to grow to USD 1.3 trillion, with the E7 countries -- Brazil, China, India, Indonesia, Mexico, Russia and Turkey. The rapid induction in the market throws up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base. New drug approvals by the FDA have risen to near-record levels in the past two years: of the 45 medicines approved by the agency in 2015, 60 per cent went through one of the agency’s fast-track processes. This is good news for a pharma industry under pressure from investors and society to find ways of reducing the 10-15 years it typically takes to get a new drug to market and the resulting heavy costs and high prices. A good pharmacovigilance will easily identify the risk factors in the shortest time so that the harmful effects can be avoided or minimized.
12th Annual Pharmacovigilance 2017 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 organisations 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 pharmacovigilance requirements, and to improve their organisations' compliance with pharmacovigilance 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 pharmacovigilance development. It gives me great pleasure in welcoming all of you to the Virtue Insight’s 12th Pharmacovigilance 2017. I wish and pray that all our efforts will be beneficial to our industries and to our country at large.
- Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading?
- Updates towards of legislation, policies, systems, technology, communication strategies and best practice in PV
- The effect of Brexit on Pharmacovigilance
- Specifics of the GVP module V on Risk Management Systems
- Emerging signal detection data gathering successful tools to highlight emerging risks
- Analysing the Challenges and Opportunities to optimize the overall PV ecosystem for maximum benefit
- Revised GVP guidance on signal management – how to implement?
- Updates to PSUR, PBRERs, DSUR, PASS
- Building cost effective and scalable systems
- Case studies from various countries on the PV frameworks around the world
- Business development and models in clinical trials
- Good Clinical Practices and Good Pharmacovigilance practices
- IT and new technologies for improvement of PV and clinical research
- 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 - How to set it 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
- Investigating the current regulations and guidelines on USA and EU PV
- The developing regulatory framework in advanced and developing markets
- Accelerating new medicine introduction in developing world & overcoming challenges
- Be part of a major networking opportunity
WHO SHOULD ATTEND:-
CEO’s, CTO’s, CIO’s, Presidents, VPs, Directors, Heads, Managers, Scientific Advisors, Consultants of:
- 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
- Medical Affairs
- Regulatory Affairs and Compliance
- Information technology
- Sales and Marketing
WHY SHOULD YOU ATTEND:-
12th Pharmacovigilance 2017 – “Uniting “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management"
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway. Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margins.
More updated info on the event on our conference webpage - http://www.virtueinsight.com/pharma/12th-Pharmacovigilance-2017/