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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.
Add to this strict new EU data protection laws which affect data transfers to the USA — you need to be aware! It will provide key facts on the new requirements and allow participants to make sure that they are prepared for the changes.
Changes include using an electronic portal to obtain a single authorization with no direct contact with ethics committees!
This Regulation will replace current clinical trial legislation. What is its impact on pharmacovigilance activities? This operating model has led to an increase in the scope of service that suppliers are taking on to support Pharmacovigilance activities.
Given the expectation from global regulators and other stakeholders to have Pharma and Biotech companies accountability for delegated activities, implementing an appropriate vendor oversight framework is critical. This discussion will focus on the key elements that make up a successful vendor oversight program.
How ready can we be? PV is at the Center but cannot do it alone. How to mobilize internal and external stakeholders? Trends from recent PV inspections findings Risk based selection criteria for auditing PV business partners: Methodologies, scope and oversight Relationship to other GxPs inspections which can include PV topics: Requirements of risk management plans from an industry point of view How to put Benefit-risk assessments into practice?
How to write a successful risk management plan? Including the patient in the benefit: Integrative Approach to Patient Safety Investing in safety- How failures in safety programs have resulted in in of more than half of all project closures in pharmaceuticals? Reference Safety Information RSI for biopharmaceutical products encompasses tools to communicate clinically-important medical concepts, particularly to healthcare providers; The approach to developing and simplifying RSI is not harmonized, despite existing regulatory guidance; MedDRA Labeling Groupings MLGs may facilitate simplification of RSI by grouping similar MedDRA terms to communicate unique medical concepts when not appropriately supported by the established MedDRA hierarchy; MLGs would also facilitate calculation of frequencies of suspected adverse reactions from clinical trial data and for comparison of frequencies between products and, perhaps, across indications, populations, or posology ; Points to consider in adopting a harmonized approach to development, sustainability, and pragmatic application of MLGs in RSI are being developed by CIOMS.
What are the current regulatory and practical challenges of the Risk Management Plan and how can you identify potential improvements? PV - Laws, Regulations, Guidelines and Best Practices How do marketing authorisation holders ensure they are up-to-date with current legal regulatory regulations and guidelines?
Up-to-date information on all aspects of compliance in pharmacovigilance both pre-marketing and post-marketing The effect of Brexit on Pharmacovigilance Moderator: He is currently co-chairing the ASA safety working group, and is a deputy topics-leader in the ICH E17 working group on multi-regional clinical trials.
He has played a critical role in shaping the current vision of the Regulatory Affairs group with renewed emphasis on lean compliance, efficient systems and best practices, and a focus on talent to meet the needs of the business today and in the future.
Teginder is widely recognized for his technical expertise, outstanding people leadership and focus on delivering results spanning 18 years in industry. David has more than 30 years of experience in the biopharmaceuticals industry in different functions.
He has been with AstraZeneca for 15 years working in preclinical safety and patient safety.
His focus within patient safety is to bring in new technology and capabilities to improve the prediction, detection and mitigation of potential signals.
David received his Ph. D in toxicology and an M. They research, develop, manufacture and market biotherapies that are used to treat serious and rare conditions. Users of their therapies rely on them for their quality of life and, in many cases, for life itself.
He is also responsible two large European projects to improve drug safety monitoring."While loneliness and social isolation are often used interchangeably, there are notable differences between the two. Social isolation is defined as a lack of contact with other individuals, while loneliness is the feeling that one is emotionally disconnected from others.
ive sensors. Mutual Interference One of the most serious problems with active sensors is interference. As a growing number of autonomous vehicles hit the streets, the number of sensors increases. The best content marketing brands push the boundaries and inspire us to rethink our own content.
Here, 50 best content marketing examples of The Nightmare Maker - Chapter Four: He looked me in the eyes as I listened to what he said. "So I think you are in grave danger with the other nightmare makers because they want to know what you do to get through the dream catchers," he finished.
CONFERENCE INTRODUCTION: Global Pharmacovigilance Market expected to Reach US$ bn by expanding at a CAGR of % from to and also expected to reach a market size of $ billion by As a follow-up to Tuesday’s post about the majority-minority public schools in Oslo, the following brief account reports the latest statistics on the cultural enrichment of schools in Austria.
Vienna is the most fully enriched location, and seems to be in roughly the same situation as Oslo. Many thanks to Hermes for the translation from grupobittia.com