Konferenzen  >  Medizin & Gesundheitswesen  >  Translationale Medizin, Klinische Studien

FDAMap

Many pharmaceutical, biotechnology, and medical device companies engage one or more Clinical Research Organizations (CROs) to conduct their clinical trials. However, managing a study through a CRO presents unique challenges compared to in-house operations, yet companies frequently lack formal training for this transition. Moreover, the recent update to the ICH Good Clinical Practice (GCP) guidelines underscores the Sponsor's responsibility to actively oversee their trials. Regulatory agencies are increasingly scrutinizing this aspect, identifying it as a potential weakness within Sponsor companies. This workshop addresses these critical issues by providing comprehensive training on effective CRO oversight. Participants will gain the knowledge and skills necessary to navigate the complexities of managing CRO-run projects, ensuring regulatory compliance, and optimizing trial outcomes. Through interactive sessions and practical insights, attendees will learn how to enhance their oversight practices and strengthen their organization's approach to clinical trial management.

Cro, Clinical Trial, Clinical Research Organizations, FDA Regulations, FDA Compliance

FDAMap

Manufacturing an investigational product for the initial pilot clinical trials can be a complex and costly endeavor for developers. These first-in-man and pilot clinical trials, usually conducted with a small number of healthy participants, are primarily aimed at establishing safety. Therefore, they do not require a significant amount of investigational material. Recognizing this, the US FDA allows developers to test early-stage investigational products under relaxed GMP requirements.

FDA, Gmp, Clinical Trials, FDA Regulations, FDA Compliance,

Legislation in der Medizin und Pharmakologie,    Pharmakologie und Arzneimittelentwicklung

Virtue Insight

16th Annual Clinical Trials Summit 2025 will provide a platform to discuss on the futuristic advancements in Clinical Trials and clinical research. This multidisciplinary program involves broad participation of people from Clinical Trials community who are focused on learning more about clinical research, Clinical Trials planning & management. This event opens discussion of timely topics of mutual theoretical and practical interest for clinical trial investigators who are developing new drugs and biologics.

Tel.: [9361957193];     Email: Kavitha@virtueinsight.co.in

clinical trials, clinical research, CROs, Clinical studies, drugs, regulatory, patients, clinical R&D, Medical Affairs, Regulatory Affairs, Quality control, pharma, pharmaceuticals

FDAMap

Many pharmaceutical, biotechnology, and medical device companies engage one or more Clinical Research Organizations (CROs) to conduct their clinical trials. However, managing a study through a CRO presents unique challenges compared to in-house operations, yet companies frequently lack formal training for this transition. Moreover, the recent update to the ICH Good Clinical Practice (GCP) guidelines underscores the Sponsor’s responsibility to actively oversee their trials. Regulatory agencies are increasingly scrutinizing this aspect, identifying it as a potential weakness within Sponsor companies. This workshop addresses these critical issues by providing comprehensive training on effective CRO oversight. Participants will gain the knowledge and skills necessary to navigate the complexities of managing CRO-run projects, ensuring regulatory compliance, and optimizing trial outcomes. Through interactive sessions and practical insights, attendees will learn how to enhance their oversight practices and strengthen their organization’s approach to clinical trial management.

Cro, Clinical Research Organizations, Good Clinical Practice, Clinical Trial Management

Legislation in der Medizin und Pharmakologie,    Pharmakologie und Arzneimittelentwicklung

FDAMap

Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. Most of the refuse-to-accept deficiencies are due to the inexperience of the 510k writers, who ignore the FDA rules. Writing and assembling a complete and well structured 510(k) submission will certainly improve the likelihood of FDA clearance on the first round.

FDA, 510(k) Submissions, FDA Regulations, FDA Compliance

Legislation in der Medizin und Pharmakologie,    Pharmakologie und Arzneimittelentwicklung

CRUK, ESMO, Unicancer

The Molecular Analysis for Precision Oncology Congress 2025 will take place from 15 to 16 September in Paris, France, uniting leading experts in oncology, molecular diagnostics, and precision medicine for dynamic discussions and collaboration, with a focus on decoding the molecular bases of cancer to enable precision oncology. The congress will delve into transformative topics shaping cancer research, including cancer prevention, interception, epigenetics, metastasis, and cancer evolution, offering a deeper understanding of mechanisms driving progression and resistance.

MAP Congress Team;     Tel.: [+41 (0)91 973 19 47];     Email: map@esmo.org

molecular oncology, precision medicine, molecular diagnostics, cancer prevention, cancer interception, epigenetics, metastasis, cancer evolution, cancer resistance, artificial intelligence in oncology, cancer immunology, immunotherapy, aging and senescence, microbiome and cancer, metabolism dysregulation, therapeutic vulnerabilities, cancer research, oncology collaboration, AI-driven diagnostics, innovative cancer treatments

Onkologie,    Pharmakogenomik, Personalisierte Medizin

The European Association for Cancer Research (EACR), with support from The Organisation of European Cancer Institutes (OECI)

This virtual event will explore how meaningful involvement of cancer advocates throughout the research process can lead to impactful cancer research. We will highlight practical examples and offer insights into how researchers, clinicians, and patient advocates can work together to bridge gaps between science and cancer care. Participants will better understand the opportunities and challenges in shaping a collaborative research culture to advance research and improve cancer care.

Chris Iliffe (Conference Officer);     Tel.: [N/A];     Email: christopher.iliffe@eacr.org

cancer research, oncology, cancer patients, patient perspective, patient advocacy, cancer care, cancer treatment, patient quality of life, cancer symptom management, cancer therapy side effects, innovative therapy development, collaborative research

Onkologie,    Medizintechnik

The European Association for Cancer Research (EACR)

This conference will explore the fundamental mechanisms controlling cancer cell plasticity at multiple biological levels including the epigenome, transcriptome, metabolome, and cellular microenvironment. Our panel of expert speakers will also discuss innovative approaches to target cell plasticity using novel pharmacological interventions that aim to prevent or reverse the adaptive mechanisms cancer cells use to circumvent conventional therapies.

Chris Iliffe (Conference Officer);     Tel.: [N/A];     Email: christopher.iliffe@eacr.org

cancer research, oncology, cancer cell biology, cancer cell plasticity, cancer epigenetics, cellular microenvironment, tumour microenvironment, tumour heterogeneity, cancer transcriptomics, metabolic reprogramming in cancer, phenotypic changes in cancer, cancer progression, cancer therapy resistance, virtual academic conference

Onkologie,    Molekularbiologie