University of Cardiff

DUBLIN--( BUSINESS WIRE )--The "Clinical Research Project Management Training Course" conference has been added to ResearchAndMarkets.com's offering. Setting up and running clinical research projects is a complex process that needs effective project management. The course includes an emphasis on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. It is essential to manage clinical research projects within the set time frame, to budget and the right quality standard. With ever-increasing pressures on clinical research professionals, the use of project management can provide essential tools and techniques and be a key factor in the successful completion of such projects including bringing a drug or medical device to market. This interactive three-day course has been designed to provide participants with a thorough understanding of both technical and interpersonal project management skills in clinical research projects. Interactive exercises are used to aid the learner in the application of clinical project management concepts and principles so they can easily use the tools to improve the success of existing or future clinical research projects. Benefits of Attending Acquire an in-depth understanding of technical project management methodologies and techniques to apply to clinical projects, including agile project management Learn how to incorporate these project management processes into everyday working practices and your currentcl projects Understand how to blend together both the technical aspects of project management and the essential interpersonal skills Discover how to build core competencies to become an even more effective project manager Discuss how to get the best results in a project team environment Certification CPD: 18 hours for your records Certificate of completion Who Should Attend: This course has been specifically designed to address the needs of clinical research professionals as well as those in the medical device and animal health industries. The programme will benefit both newly appointed and established project team leaders/managers in clinical research wishing to refresh or update their skills. The course will be of benefit to: Project managers looking to gain experience in clinical research project management Project leaders that are unfamiliar with project management tools and principles Clinical research professionals transitioning to project management roles/functions Clinical trial administrators Medical advisers Data managers Clinical scientists Academic and non-commercial clinical researchers Regulatory authority professionals Service providers including CROs and contractors Agenda: Day 1 What is project management in clinical research? Current and emerging ways to manage projects in clinical research including agile project management Using a project management process for improving the success of your own clinical research projects Sharing experiences and lessons learned from previous clinical research projects Setting clear project objectives and defining the scope of clinical research projects Aligning the project objectives with the strategic and financial business objectives Defining the result, the cost and the time The project brief or charter or business case Creating the strategy for your clinical research projects Understanding the importance of having an overall strategy for your projects Develop and explore options Strategic options for clinical trial projects Detailed project planning of clinical research projects Identifying the key project activities using a Work Breakdown Structure (WBS) and defining the work packages Allocate responsibilities using the responsibility matrix Planning a realistic schedule using Gantt analysis and setting clear milestones Clinical trial regulatory and GCP activities - meeting quality expectations Resource planning Budget planning Communication plan, Quality plan and the TMF plan Contracts Implementing risk management and contingency planning for your clinical research project Project management software and tracking systems Day 2 Clinical trial CRO and service provider oversight and management CRO Oversight Management of CROs/service providers on clinical research projects How milestones measures and reviews are used to enhance visibility and deliver results Good practices for managing outsourced clinical trial activities and projects Patient/subject recruitment and retention Improving patient recruitment and retention Clinical trial diversity Project implementation and control for your clinical research projects Identifying the possible causes of problems in clinical research projects Effective communication and how to manage stakeholders Overcoming enablers and constraints of your projects Implementing project control and reporting systems Metrics and KPIs Change requests Monitoring project activities, progress and performance Project review and closure of clinical research projects Close the project Identifying the critical success factors and learning from mistakes for continuous improvement Day 3 Clinical research pharma/bio leadership skills Defining the role and skills of effective pharma project leaders Leadership style Improving your interpersonal skills as a leader Motivate to achieve project milestones Understand the principles and practices of motivation Understand how to motivate different people and what motivates your project team Completion of a self-evaluation questionnaire Building pharma/bio clinical project teams How to modify your leadership style to get the best results in a project team environment Understand team management throughout the project life cycle Building a high-performance team Optimising project communication and cross-cultural communication Effective communication and how to gain project buy-in Preventing and overcoming misunderstandings and dealing with conflict Communicating effectively with the project stakeholders including cross-culturally Technology approaches to improve and speed up your clinical projects Emerging industry initiatives for improving, accelerating, and managing clinical trial projects, AI applications. Decentralized and hybrid trials Clinical trial project time management Identifying and managing common time-wasting activities in your projects Maximising your prime time to improve your personal performance Develop approaches to optimise time management Speakers: Laura Brown Pharmaceutical QA and Training Consultant University of Cardiff Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years' experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal 2017. For more information about this conference visit https://www.researchandmarkets.com/r/xec3ju About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

FRIDAY, Aug. 16, 2024 -- Individuals are less likely to have type 1 diabetes if their mother has the condition than if their father is affected, according to a study scheduled to be presented at the annual meeting of the European Association for the Study of Diabetes, being held from Sept. 9 to 13 in Madrid. Lowri A. Allen, M.B.Ch.B., from Cardiff University in the United Kingdom, and colleagues conducted a meta-analysis across five cohorts of individuals with type 1 diabetes (total, 11,475 individuals) to compare the proportion of individuals with affected fathers versus mothers. The researchers found that almost twice as many individuals had an affected father versus mother (overall odds ratio [OR], 1.79). The proportion of individuals with an affected father was higher both among individuals diagnosed with type 1 diabetes older than 18 years (OR, 1.64) and those 18 years or younger (OR, 1.80). There was an excess of individuals with affected fathers only if parental diagnosis was before offspring birth compared with diagnosis after birth. Age at diagnosis and type 1 diabetes-free survival curves were similar among offspring of affected fathers and mothers. "Further research is needed but ultimately, we hope that it might be possible in the future to offer treatments at the very earliest stages of life to prevent the onset of type 1 diabetes in individuals who are at particularly high risk of the disease," Allen said in a statement. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

DUBLIN--( BUSINESS WIRE )--The "EU (European Union) Clinical Trial Regulation 536/2014: Overview and Implementation Experience Training Course" conference has been added to ResearchAndMarkets.com's offering. The CTR, which became applicable on 31st January 2022, is directly effective in all EU Member States and introduced the biggest change to the legal framework surrounding clinical trials since the Clinical Trials Directive was implemented. The CTR has already had a global impact as all interventional trials that take place even partially in an EU Member State need to comply with its regulatory requirements, at every stage of the trial life cycle. This course will provide an essential understanding of the new Regulation and key associated implementing acts and other texts for carrying out clinical trials in the EU. It will provide an essential understanding to help with compliance with the new Regulation and key associated implementing acts and other texts for carrying out clinical trials in the EU. The programme will highlight the most important of these key requirements and how these have impacted so far on trials for biopharmaceutical companies, vendors and study sites since going live in 2022. This will include explaining how the regulation has harmonised procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial CTIS (Clinical Trial Information System). Who Should Attend: This event is ideal for anyone requiring an understanding and update on the EU Clinical Trials Regulation (536/2014). The course is relevant for those working in regulatory, clinical research, clinical operations, project management, pharmacovigilance, quality assurance (GCP auditors), vendor/CRO professionals, study sites and other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products. It will also be of interest to those departments who liaise with/support clinical trial personnel, and all other professionals who want to know more about this important new regulation. Benefits of attending: Gain an overview of the Clinical Trial Regulation and changes for trials in the EU Understand the new Clinical Trials Information system (CTIS) and experience so far Share experiences of implementing the Clinical Trials Regulation Discuss the Clinical Trial Regulation implementation documents Understand the EU clinical trial authorisation process and experience Key topics to be covered include: Clinical Trials Information System Clinical trial authorisation process Safety reporting Requirements for managing investigational medicinal products Clinical trials conducted on children Regulatory inspection Certifications: CPD : 12 hours for your records Certificate of completion Agenda: Day 1 Background to the EU Clinical Trial Regulation The development of European clinical trial legislation The framework of clinical trial regulations in Europe Experience and challenges so far since Go Live Overview of the key requirements and changes Including: Roles and responsibilities Non-EU sponsors Transparency Co-sponsorship Harmonisation templates Investigator Curriculum Vitae Declaration of interest template Site suitability Informed consent and patient recruitment procedure Compensation for trial participants Clinical Trial Regulatory Authorisation The significant changes in clinical trial approval in the EU The new clinical trial authorisation process Substantial modifications Notices Requests for information End of study reports Day 2 The new CTIS (Clinical Trial Information System) What is CTIS? How to use CTIS CTIS training Transitioning to the regulation Clinical Trial Ethical Approval and Informed Consent Ethical approval considerations under the Regulation Informed consent changes under the regulation EU Clinical Trial Regulation Documents Serious breaches Risk-proportionate approaches in clinical trials Summaries of clinical trial results for laypersons Q&A document Manufacturing GMP requirements Key requirements for IMPs and auxiliary medicinal products Labelling and packaging Safety reporting Adverse event reporting - requirements and definitions Safety reporting requirements Safety reporting including RSI (reference safety information) Clinical Trials in Children Considerations for running clinical trials on children Assent and consent Key differences and requirements for running clinical trials on children compared to adults Inspection preparation under the new regulation GCP and GMP inspection guidelines How to prepare for inspection in the EU under the new EU Clinical Trial Requirements TMF guideline documentation considerations for inspection Speakers: Laura Brown Pharmaceutical QA and Training Consultant University of Cardiff Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years' experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal 2017. For more information about this conference visit https://www.researchandmarkets.com/r/6ww82 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.