Strategies for best practice in benefit-risk management Using technology to enhance interactive connection with patients Providing valuable insight into the functioning of the PRAC Who are the most important stakeholders and how does the PRAC cooperate with them? Initiating a new product portfolio and PV implications to enable a successful launch into market An overview of pharmacovigilance, pharmacoepidemiology, pharmaceutical risk management, and medication error prevention. Does the shift towards emerging markets pose a risk to drug safety and biased data reports?
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.
View Merck & Co. and Pfizer Inc Session 10 from MGT at University of California, Davis. Strategy in the Twenty-first century Pharmaceutical industry: Merck & Co. and Pfizer Inc. CASE STUDY75%(4). Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. Gain free stock research access to stock picks, stock . The largest event for senior-level executives across the entire business transformation & operational excellence eco-system.
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.18th Annual Pharmaceutical and Medical Device Compliance Congress.
November 6th-8th at the Mandarin Oriental in Washington DC.
A partnership of scientific societies with the goal of improving public health through a collaborative interdisciplinary approach. The global pharmaceutical industry has gone through substantial changes in the last few decade and pharmaceutical firms face major challenges, including headline-grabbing litigation, imminent patent Strategy in the 21st Century Pharmaceutical Industry: Merck & Co and Pfizer Inc | .
Sanj K. Patel is the CEO and Chairman of the Board of Kiniksa Pharmaceuticals, a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Strategy in the Twenty-First Century Pharmaceutical Industry: Merck & Co.
and Pfizer Inc. Donny Marthen Sitompul International Strategic Management drug, %(1). Strategy in the Twenty-First Century PharmaceuticalIndustry: Merck & Co. and Pfizer Inc. Case Solution. Introduction. Thiscase illustrates theimportance of determining the changes in the pharmaceutical industry in the past couple of years, and to concludea strategic impact of the particular giant companiesthat operate within a certain level of countries.