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1
5th Annual Extractables & Leachables Summit 2025
27 fév 2025 - 28 fév 2025 • Prague, République tchèque
Organisateur:
Uventia Global
Résumé:
The assessment of extractables and leachables is a critical step in the biopharmaceutical development process. The interactions between pharmaceutical products and drug delivery systems, bioprocess manufacturing systems, and container closing systems are of special concern for regulatory bodies. Therefore, it is necessary to carefully examine the migration of mobile molecules from the materials and components utilized in the production and storage of pharmaceuticals. We organize a virtual conference to facilitate discussion on the most recent analytical techniques, regulatory updates, risk-based E&L programs, chemical characterization and toxicological risk assessment among scientists, toxicologists and E&L managers. We also cover ISO 10993-18, medical device materials, analytical and safety thresholds and customized systems for different product types.
Contact:
Email.: yuliia.terletska@uventia.com
Sujets:
Updated regulatory guidelines for E&L testing, How to implement effective E&L study designs, Risk assessing extractables and leachables, Toxicological Risk Assessment, Single Use Systems (SUS), drug products, X-ray vs. gamma, rubber closures, E&L testing for medical devices, bioprocess equipment, Testing for E&L in packaging materials, E&L assessment of cell and gene therapies
Identifiant de l'évènement:
1645202
2
One Day Online Training — One Day Online Training in Clinical Project Management
11 mar 2025 • Washington DC, États-Unis
Organisateur:
FDAMap
Résumé:
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.
Sujets:
Clinical Project Management, Clinical Project Managers, FDA Regulations, FDA Compliance,
Identifiant de l'évènement:
1645886
3
Precision Med TRI-CON 2025
11 mar 2025 - 13 mar 2025 • San Diego, États-Unis
Organisateur:
CHI
Résumé:
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!
Contact:
Tél.: [781.972.5400];     Email.: chi@healthtech.com
Identifiant de l'évènement:
1652348
Sujets apparentés:
4
FDA Compliant SOPs for Regulated Industry: How to Create High Quality SOPs that Your Team and FDA Auditors Will Love
13 mar 2025 - 14 mar 2025 • Washington DC - online, États-Unis
Organisateur:
FDAMap
Résumé:
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.
Sujets:
Sop, Quality Management System, FDA Regulation, FDA Compliance
Identifiant de l'évènement:
1646514
5
FDA Compliant SOPs for Regulated Industry: How to Create High Quality SOPs that Your Team and FDA Auditors Will Love
13 mar 2025 - 14 mar 2025 • Washington DC - online, États-Unis
Organisateur:
FDAMap
Résumé:
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.
Sujets:
Sop, Quality Management System, FDA Regulation, FDA Compliance
Identifiant de l'évènement:
1647258
6
EACR Persister Cells: from Bacteria to Cancer
18 mar 2025 - 20 mar 2025 • Lyon, France
Organisateur:
The European Association for Cancer Research
Résumé:
This meeting will explore the burgeoning field of cancer persister cells, a rare subset of cells which have emerged over the last decade as a significant factor in cancer treatment failure. Unlike resistance cells, which harbour genetic alterations enabling survival despite therapy, persister cells exhibit transient drug tolerance through reversible, non-mutational mechanisms. Our conference on this topic will bring together investigators from across the world to delve into molecular mechanisms, therapeutic targets, and emerging clinical implications of cancer persister cells, fostering collaboration and community-building in this pivotal and rapidly growing area of research.
Contact:
Email.: christopher.iliffe@eacr.org
Sujets:
cancer research, oncology, cancer persister cells, cancer resistant cells, non-genetic drug resistance, treatment response, treatment success, treatment failure, molecular mechanisms of resistance and persistence, novel study methodologies, targeting vulnerabilities within persister cells, clinical implications and applications
Identifiant de l'évènement:
1631700
Sujets apparentés:
7
Technical and Regulatory Writing for FDA-Regulated Industry
20 mar 2025 - 21 mar 2025 • Washington DC - online, États-Unis
Organisateur:
FDAMap
Résumé:
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.
Sujets:
Technical Writing, Regulatory Writing, FDA Regulations, FDA compliance
Identifiant de l'évènement:
1646480
8
Technical and Regulatory Writing for FDA-Regulated Industry
20 mar 2025 - 21 mar 2025 • Washington DC - online, États-Unis
Organisateur:
FDAMap
Résumé:
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.
Sujets:
Technical Writing, Regulatory Writing, FDA Regulations, FDA compliance
Identifiant de l'évènement:
1647224
9
G Sai Lakshmi — International Conference on Pharmacovigilance and Regulatory Affairs
24 mar 2025 - 26 mar 2025 • Italy, Italie
Organisateur:
pagesconferences
Résumé:
International Conference on Pharmacovigilance and Regulatory Affairs (ICPRA-2025), a premier event focusing on the latest developments in the field of Pharmacovigilance and Regulatory Affairs which is going to be held in Rome, Italy during March 24-26, 2025.

This Conference will bring together pharmacovigilance professionals, researchers, and experts from around the world to discuss the latest advancements in Pharmacovigilance and Regulatory Affairs. Join us for a day of education, networking, and knowledge exchange. This event will provide a valuable opportunity for the attendees to learn from each other’s work, exchange ideas, create networks and build collaborations.

Contact:
Tél.: [910033064];     Email.: icpra2025@pagesconferences.org
Sujets:
Pharmacovigilance Drug safety Drug Surveillance Pharmacology
Identifiant de l'évènement:
1637450
10
Strategic Alliance Management Congress
25 mar 2025 - 26 mar 2025 • Boston, États-Unis
Organisateur:
CHI
Résumé:
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.

Contact:
Tél.: [781.972.5400];     Email.: chi@healthtech.com
Identifiant de l'évènement:
1651899
11
Drug Discovery Chemistry 2025
14 avr 2025 - 17 avr 2025 • San Diego, États-Unis
Organisateur:
CHI
Résumé:
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!
Identifiant de l'évènement:
1654668
12
IDDST-2025 — 21th Annual Congress of International Drug Discovery Science and Technology
12 mai 2025 - 14 mai 2025 • Kobe, Japon
Organisateur:
World High Technology Society
Résumé:
The Annual Congress of International Drug Discovery Science and Technology (IDDST) initiated since 2003, it has been successfully hosted in Shanghai (China), Beijing (China), Shenzhen(China), Nanjing (China), Haikou(China), Suzhou (China), Xi'an(China), Gyeonggi (South Korea), Osaka (Japan), Boston (USA), Kyoto (Japan), Tokyo (Japan) and Amsterdam (the Netherlands) and has attracted more than 10,000 participants from over 50 countries and regions in the previous 20 years.
Contact:
Organizing Committee of IDDST;     Tél.: [0086-411-84799629];     Email.: irene@iddst.com
Identifiant de l'évènement:
1646635
13
IDDST-2025 — 21th Annual Congress of International Drug Discovery Science and Technology
12 mai 2025 - 14 mai 2025 • Kobe, Japon
Organisateur:
World High Technology Society
Résumé:
The Annual Congress of International Drug Discovery Science and Technology (IDDST) initiated since 2003, it has been successfully hosted in Shanghai (China), Beijing (China), Shenzhen(China), Nanjing (China), Haikou(China), Suzhou (China), Xi'an(China), Gyeonggi (South Korea), Osaka (Japan), Boston (USA), Kyoto (Japan), Tokyo (Japan) and Amsterdam (the Netherlands) and has attracted more than 10,000 participants from over 50 countries and regions in the previous 20 years.
Contact:
Organizing Committee of IDDST;     Tél.: [0086-411-84799629];     Email.: irene@iddst.com
Identifiant de l'évènement:
1647291
14
EuroPotent Therapeutics Summit
22 mai 2025 - 23 mai 2025 • Francfort, Allemagne
Organisateur:
Veridon Global Pvt Ltd
Résumé:
The EuroPotent Therapeutics Summit, hosted by Veridon Global is set to convene leading experts, innovators, and decision-makers in the field of high-potency active pharmaceutical ingredients (HPAPI) and potent therapeutic development. It will take place on 22nd-23rd May 2025 in Frankfurt, Germany, offering an unparalleled platform for professionals in the pharmaceutical and biotech sectors to explore the latest developments in HPAPI. With Europe at the forefront of global regulatory standards, this summit will provide a comprehensive overview of the evolving regulatory landscape, with a focus on compliance challenges, emerging technologies, and cutting-edge safety practices specific to HPAPI manufacturing. Key themes will include advancements in containment and isolation technologies, environmental sustainability, and the integration of digital tools to optimize production processes while ensuring safety and regulatory adherence.
Contact:
Tél.: [+1 6672600490];     Email.: marketing@veridonglobal.com
Sujets:
EuroPotent Therapeutics Summit, EuroPotent Therapeutics Conference, EuroPotent Therapeutics, Pharma conference in Europe, high-potency active pharmaceutical ingredients, HPAPI, HPAPI development, HPAPI manufacturing, drug development
Identifiant de l'évènement:
1652412
15
EVIDENCE 360: RWE, Pricing & Reimbursement Summit Europe
26 mai 2025 - 27 mai 2025 • Francfort, Allemagne
Organisateur:
Veridon Global Pvt Ltd
Résumé:
Veridon Global is proud to present the EVIDENCE 360: RWE, Pricing & Reimbursement Summit Europe on 26th-27th May 2025 in Frankfurt, Germany. This two-day summit is a must-attend event for healthcare professionals, pharmaceutical leaders, policymakers, and researchers, offering an in-depth exploration of the latest trends, challenges, and innovations in Real-World Evidence (RWE), pricing strategies, and reimbursement frameworks in Europe.

As the healthcare landscape evolves, RWE is becoming increasingly vital for decision-making, influencing how drugs are priced, reimbursed, and integrated into healthcare systems. This summit will address the current challenges in RWE adoption, including the complexities of data quality, integration of electronic health records, addressing key topics such as the integration of RWE into pricing strategies, the alignment of RWE with health technology assessments (HTAs), and the complexities surrounding cross-border reimbursement policies. Attendees will gain valuable insights into the evolving role of RWE in shaping pricing models and market access strategies within the European context, focusing on how healthcare systems are evolving to incorporate this data for more value-based and patient-centric decisions.

Contact:
Tél.: [+1 6672600490];     Email.: marketing@veridonglobal.com
Sujets:
EVIDENCE 360, EVIDENCE 360 summit, Real-World Evidence, Real-World Evidence trends, Real-World Evidence summit, Real-World Evidence conference in Europe,
Identifiant de l'évènement:
1652455
16
IDDST — 21th Annual Congress of International Drug Discovery Science and Technology
24 sep 2025 - 26 sep 2025 • Shanghai, Chine
Organisateur:
World High Technology Society
Résumé:
The Annual Congress of International Drug Discovery Science & Technology (IDDST), initiated from 2003, has been successfully organized in Shanghai (China), Beijing (China), Shenzhen (China), Nanjing (China), Haikou (China), Suzhou (China), Xi’an (China), Gyeonggi (South Korea), Osaka (Japan), Boston (USA), Kyoto (Japan), Tokyo (Japan), Amsterdam (the Netherlands), Osaka (Japan) and Budapest (Hungary) and has attracted more than 10000 participants from over 50 countries and regions in the previous 20 years. The 21th IDDST (Europe) will be held during June 18-20, 2025 at Stockholm, Sweden. It continues to expand with magnificent scientific and social programs to maximize your network in a free communication meeting environment.

The 21th IDDST (Europe) will host leading scientists from the academia and industry worldwide, to discuss the latest developments in drug discovery and therapy. The program of the coming conference promises to be very interesting for both basic scientists and executives who are working in the field of drug discovery and other related areas, they will offer complete updates of recent developments and present the latest results in the remarkable separate tracks. With the participation of outstanding international experts, we hope productive discussions would stimulate new creative ideas to translate new discoveries into better practice and application.

Identifiant de l'évènement:
1652496
17
IVC 2025 — 5th Edition of International Vaccines Congress
23 oct 2025 - 25 oct 2025 • Orlando - hybrid, États-Unis
Organisateur:
Magnus Group
Résumé:
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.
Contact:
Tél.: [17029882320];     Email.: vaccines@magnusconference.com
Identifiant de l'évènement:
1654519


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Dernière mise à jour: 10 février 2025