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Health Care Compliance Association (HCCA)

The Academy is designed for compliance professionals across the healthcare spectrum, including Hospitals, Skilled Nursing Facilities, Managed Care & Medicare Advantage, Ambulatory Services, Durable Medical Equipment, Home Health, Physician Practices, Clinical Laboratories, Dentistry, Pharmaceutical Manufacturing, Hospice Care and all other healthcare-related entities.

Health Care Compliance Association (HCCA)

Compliance professionals in managed care face an ever-changing landscape shaped by evolving regulations, emerging risks, and growing operational complexity. The 2026 Managed Care Compliance Conference is your opportunity to explore the latest developments, gain practical tools, and connect with peers navigating similar challenges.

Formation sur la protection des données ,    Gestion des données cliniques, télésanté

ComplianceOnline

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. Reduce costs, usually by two-thirds, for compliance with electronic records, Learn how to use electronic records and electronic signatures to maximize productivity, Understand what is expected in Part 11 and Annex 11 inspections so you are prepared, Avoid 483 and Warning Letters, Understand the responsibilities and specific duties of your staff including IT and QA, Learn how to perform risk-based Computer System Validation using fill-in-the-blank templates, Learn how to buy COTS software and qualify vendors

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FDAMap

Are you ready to elevate your clinical trial process with the power of smart trials? This one-day virtual program is your gateway to transforming how trials are conducted. Imagine cutting timelines, slashing costs, and driving incredible ROI with advanced virtual tools, data-driven methodologies, and streamlined operations! This program will take you from traditional trial challenges to a smart, virtual-first strategy that amplifies results and redefines success.

FDA, Smart Clinical Trials, Clinical Trials, FDA Regulation, FDA Compliance

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

Health Care Compliance Association (HCCA)

HCCA’s four-day Healthcare Compliance Essentials Workshop is designed to provide foundational education on the key elements of a compliance program in a convenient virtual format. If you’re new to or have minimal experience in compliance management, make this workshop a priority and get the essential knowledge you need to move forward confidently. Our instructors are compliance and ethics leaders who will guide you through the fundamentals and help you build a foundation for your compliance career.

Formation sur la protection des données ,    Gestion des données cliniques, télésanté

ComplianceOnline

In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed operations you retain and which you outsource; what the current expectations and best industry practices are for selecting, qualifying and monitoring your contractors to ensure they are meeting your requirements; and how to build a quality system framework that is not excessive for your current needs, but has the structure and integration to "grow with you" as the scope your operations change in the coming months and years.

GMP compliance for virtual companies, contract manufacturing organizations (CMOs), contract research organizations (CROs), Contract Laboratories, quality agreement, technical agreement, good clinical practice (GCP), FDA inspection for virtual companies

Health Care Compliance Association (HCCA)

This in-person event offers board members and their compliance officers a unique opportunity to come together for education, discussion, and networking with dozens of experts in a shared experience that will support effective organizational compliance efforts, uphold its core values, and strengthen its mission. Participants will learn and benefit from in-depth discussions with numerous experts to enable more effective and efficient risk mitigation across the enterprise.

Formation sur la protection des données ,    Gestion des données cliniques, télésanté

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.

FDA, Clinical Project Management, FDA Regulation, FDA Compliance

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

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 Regulation, FDA Compliance

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.

FDA, SOPs, FDA Regulation, FDA Compliance

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

Health Care Compliance Association (HCCA)

When done right, compliance investigations play a critical role in revealing risks and process gaps. They also help to build trust across your organization by demonstrating that concerns are handled with thorough follow-up. In this interactive virtual workshop, you’ll explore the core principles of effective investigations and learn how to put them into action. Perfect for anyone new to investigations, part of a small team that wears many hats, or looking for a fresh perspective, this training will help you strengthen both your process and your confidence.

Formation sur la protection des données ,    Gestion des données cliniques, télésanté

FDAMap

In the field of regulatory affairs, professionals often encounter the task of writing complex documents for diverse audiences. These documents encompass a wide range, including reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and various communication documents. 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.

FDA, ​Technical Writing, Regulatory Writing, FDA Regulation, FDA Compliance

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

CHI

OPT Congress 2026 is the leading industry event for scientists, directors, and technology providers driving innovation across oligonucleotide, mRNA, and peptide therapeutics. Now in its 11th year, this event provides a unique forum for translating cutting-edge science into transformative medicines, with expanded 2026 programming that includes the brand-new Peptides & Emerging Drug Conjugates conference. This year’s agenda brings together experts from discovery through development, with dedicated content spanning AI-enabled design, extrahepatic delivery, scalable manufacturing, and next-gen modalities including saRNA, circular RNA, and radioligand peptide conjugates.

Across four focused conferences —Oligonucleotide Discovery & Delivery, CMC & Manufacturing, mRNA & Emerging Modalities, and Peptides & Emerging Conjugates—attendees will explore 60+ scientific presentations, collaborative case studies, and real-world implementation strategies. From novel linkers and chemistries to regulatory insights, tech transfer, and delivery breakthroughs, OPT Congress fosters dialogue between pharma, biotech, academia, and technology providers. Join us for two days of actionable insights, short courses, and customizable content designed to support your therapeutic programs from bench to bedside.

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

Health Care Compliance Association (HCCA)

The Academy is designed for compliance professionals across the healthcare spectrum, including Hospitals, Skilled Nursing Facilities, Managed Care & Medicare Advantage, Ambulatory Services, Durable Medical Equipment, Home Health, Physician Practices, Clinical Laboratories, Dentistry, Pharmaceutical Manufacturing, Hospice Care and all other healthcare-related entities.

Formation sur la protection des données ,    Gestion des données cliniques, télésanté

Health Care Compliance Association (HCCA)

HCCA's Healthcare Privacy Compliance Academy is a three-and-a-half-day interactive education program with a focus on the vast body of privacy laws and regulations in place to help you protect PHI and other critical data. Our faculty of experienced practitioners provides guidance and insights on a variety of subjects, including ongoing challenges, new developments, policy changes, and regulatory updates.

Health Care Compliance Association (HCCA)

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day interactive educational program with a focus on the highly specialized and complex regulations and issues that affect research compliance professionals. Our faculty of experienced practitioners provides guidance and insights on a variety of subjects, including emerging risks and solutions specific to maintaining integrity of research in a healthcare setting.

Health Care Compliance Association (HCCA)

For three decades, the Compliance Institute (CI) has been the ultimate go-to event for healthcare compliance professionals looking to stay ahead of the game. Every year, we bring you cutting-edge education, expert insights you can actually use, and invaluable networking opportunities—all in one dynamic experience designed to take your compliance program to the next level. This year, we’re celebrating our 30th Annual Compliance Institute with an unforgettable event at the Loews Meeting Complex at Universal Orlando! Expect top-tier speakers, the latest updates on regulations and enforcement trends, program solutions from a variety of exhibitors, and interactive activities that make learning as engaging as it is impactful.

Formation sur la protection des données ,    Gestion des données cliniques, télésanté

Health Care Compliance Association (HCCA)

The Academy is designed for compliance professionals across the healthcare spectrum, including Hospitals, Skilled Nursing Facilities, Managed Care & Medicare Advantage, Ambulatory Services, Durable Medical Equipment, Home Health, Physician Practices, Clinical Laboratories, Dentistry, Pharmaceutical Manufacturing, Hospice Care and all other healthcare-related entities.

Health Care Compliance Association (HCCA)

Whether you’re a dedicated research compliance professional or working in a broader healthcare role that includes a research component, you’ll discover actionable insights that can elevate your compliance program and safeguard your organization. There are sessions for a range of knowledge levels—basic, intermediate, and advanced—so you can find content that’s most relevant to your experience and goals.

Health Care Compliance Association (HCCA)

The Academy is designed for compliance professionals across the healthcare spectrum, including Hospitals, Skilled Nursing Facilities, Managed Care & Medicare Advantage, Ambulatory Services, Durable Medical Equipment, Home Health, Physician Practices, Clinical Laboratories, Dentistry, Pharmaceutical Manufacturing, Hospice Care and all other healthcare-related entities.

Formation sur la protection des données ,    Gestion des données cliniques, télésanté

Health Care Compliance Association (HCCA)

When done right, compliance investigations play a critical role in revealing risks and process gaps. They also help to build trust across your organization by demonstrating that concerns are handled with thorough follow-up. In this interactive virtual workshop, you’ll explore the core principles of effective investigations and learn how to put them into action. Perfect for anyone new to investigations, part of a small team that wears many hats, or looking for a fresh perspective, this training will help you strengthen both your process and your confidence.

Investigation basics; Planning the investigation; Gathering evidence and documentation; Conducting interviews; Reporting results; After the investigation

Formation sur la protection des données ,    Gestion des données cliniques, télésanté

Health Care Compliance Association (HCCA)

The Academy is designed for compliance professionals across the healthcare spectrum, including Hospitals, Skilled Nursing Facilities, Managed Care & Medicare Advantage, Ambulatory Services, Durable Medical Equipment, Home Health, Physician Practices, Clinical Laboratories, Dentistry, Pharmaceutical Manufacturing, Hospice Care and all other healthcare-related entities.

Health Care Compliance Association (HCCA)

The Academy is designed for compliance professionals across the healthcare spectrum, including Hospitals, Skilled Nursing Facilities, Managed Care & Medicare Advantage, Ambulatory Services, Durable Medical Equipment, Home Health, Physician Practices, Clinical Laboratories, Dentistry, Pharmaceutical Manufacturing, Hospice Care and all other healthcare-related entities.

Formation sur la protection des données ,    Gestion des données cliniques, télésanté

Health Care Compliance Association (HCCA)

The Academy is designed for compliance professionals across the healthcare spectrum, including Hospitals, Skilled Nursing Facilities, Managed Care & Medicare Advantage, Ambulatory Services, Durable Medical Equipment, Home Health, Physician Practices, Clinical Laboratories, Dentistry, Pharmaceutical Manufacturing, Hospice Care and all other healthcare-related entities.

Formation sur la protection des données ,    Gestion des données cliniques, télésanté

Health Care Compliance Association (HCCA)

HCCA’s four-day Healthcare Compliance Essentials Workshop is designed to provide foundational education on the key elements of a compliance program in a convenient virtual format. If you’re new to or have minimal experience in compliance management, make this workshop a priority and get the essential knowledge you need to move forward confidently. Our instructors are compliance and ethics leaders who will guide you through the fundamentals and help you build a foundation for your compliance career.

Formation sur la protection des données ,    Gestion des données cliniques, télésanté

Health Care Compliance Association (HCCA)

When done right, compliance investigations play a critical role in revealing risks and process gaps. They also help to build trust across your organization by demonstrating that concerns are handled with thorough follow-up. In this interactive virtual workshop, you’ll explore the core principles of effective investigations and learn how to put them into action. Perfect for anyone new to investigations, part of a small team that wears many hats, or looking for a fresh perspective, this training will help you strengthen both your process and your confidence.

Formation sur la protection des données ,    Gestion des données cliniques, télésanté