Conférences  >  Médecine & Soins de Santé  >  Pharmacologie et développement des médicaments  >  États-Unis

FDAMap

Clinical trials are highly regulated multi-dimensional projects that require constant interactions between the regulators and the sponsors, investigators, other personnel, and even patients involved in the conduct of a given trial. There are many diverse tasks involved in the conduct of a clinical trial starting from the development of a clinical trial protocol, finding and starting clinical trial sites, filing of an IND or IDE application, approvals from IRBs, numerous documents need to be collected to demonstrate compliance with regulations; managing supplies, collecting data, writing reports, and many other things. Clinical project managers need to understand, implement, and trouble-shoot practically all aspects of the clinical trial under them. Clinical project managers have to build teams and have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. This one-of-a-kind program will train you in regulatory affairs, clinical operations, monitoring, patient recruitment and retention, planning, medical writing, safety monitoring and practically all major aspects of running a clinical trial.

Clinical Project Management, Clinical Project Managers, FDA Regulations, FDA Compliance,

Législation en médecine et pharmacologie,    Médecine translationnelle, essais cliniques

CHI

For 3 decades, the Precision Med TRI-CON has served as the leading international meeting place for the diagnostics and precision medicine community. Join over a thousand international thought leaders to discuss the latest research, technologies, innovation and business models in implementing precision medicine, biomarkers and companion diagnostics, genomic medicine, and artificial intelligence; innovation and market access strategies for at-home diagnostics, point-of-care testing and molecular diagnostics for infectious diseases; liquid biopsy and advanced diagnostics for precision oncology, including multi-cancer early detection and minimal residual disease testing. Emerging implications of faster and cheaper sequencing, AI and digital tools, and spatial biology and single-cell multiomics in advancing precision medicine will be covered in 2025. The new track on precision medicine beyond oncology will cover applications in immunology, neurology, and metabolic diseases. Join us in sunny San Diego for the in-person networking and visionary and thought-provoking keynote discussions you’ve come to expect from the TRI-CON!

Tél.: [781.972.5400];     Email.: chi@healthtech.com

FDAMap

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

Sop, Quality Management System, FDA Regulation, FDA Compliance

Législation en médecine et pharmacologie,    Médecine translationnelle, essais cliniques

FDAMap

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

Sop, Quality Management System, FDA Regulation, FDA Compliance

Législation en médecine et pharmacologie,    Médecine translationnelle, essais cliniques

FDAMap

The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others.

Technical Writing, Regulatory Writing, FDA Regulations, FDA compliance

Législation en médecine et pharmacologie,    Médecine translationnelle, essais cliniques

FDAMap

The purpose of this exclusive technical writing workshop is to provide regulatory professionals with valuable insights into best practices and regulatory strategies for crafting effective documents. The workshop will cover a spectrum of writing needs, from simple issues like minutes of meetings and correspondence notes to more intricate tasks such as producing comprehensive nonclinical and clinical study reports, as well as regulatory submissions to regulatory bodies such as FDA, EMA, Health Canada, and others.

Technical Writing, Regulatory Writing, FDA Regulations, FDA compliance

Législation en médecine et pharmacologie,    Médecine translationnelle, essais cliniques

CHI

As the biopharmaceutical industry continues to rely on alliances and collaboration with external organizations to access innovation and obtain market access, internal teams are often confronted with the increasing complexities of systematically and effectively managing partnerships throughout their lifecycle. The function and organizational capability of Alliance Management is now recognized as a critical means to ensure the successful execution of any strategic partnership, acting as a central driver of value, while alleviating aggravations, and meeting alliance goals.

Now in its twenty-second year, CHI’s Strategic Alliance Management Congress will again unite senior alliance management, business development, project management, technology transfer, and licensing professionals to network, discuss case studies, and share the components that cultivate successful partnerships. Delegates will gain strategic insights, proven tools, methods, and perspectives from a variety of leaders advancing the art of Alliance Management.

Tél.: [781.972.5400];     Email.: chi@healthtech.com

CHI

Drug Discovery Chemistry is a dynamic conference for medicinal and biophysical chemists working in pharma, biotech, and academia. Focused on discovery and optimization challenges of small molecule drug candidates, this event provides many exciting opportunities for scientists to create a unique program to hear presentations most suited to one's interests by going back and forth among concurrent tracks. Last year's event was our largest ever!

Magnus Group

Prepare to immerse yourself in the 5th Edition of the International Vaccines Congress (IVC 2025), taking place from October 23-25, 2025, in the vibrant city of Orlando, Florida, USA! This highly anticipated International Vaccines Congress 2025 will offer a unique hybrid format, seamlessly blending onsite and online experiences to maximize global reach and participation. Dive deep into the latest advancements and transformative trends in vaccine science under the theme: From Discovery to Distribution: The Path of Vaccines.

Tél.: [17029882320];     Email.: vaccines@magnusconference.com