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[KoNECT-Premier Research] Regulatory Symposia

구분 혼합교육
카테고리특화교육 > Coperation Courses > KoNECT-Premier Research
과정명[KoNECT-Premier Research] Regulatory Symposia
신청기간 2021.04.21 (10:00) ~ 2021.05.17 (24:00) 교육기간 2021.05.20 ~ 2021.05.20
학습일수/시간 1 일 / 7 시간 교육장소

실시간 화상강의(원격)

수강료   45,000원 교육정원250명

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Regulatory Symposia

Joint Educational Symposium with KoNECT

 May 20th, 2021

Education overview

Education overview

Course name

Regulatory Symposia

Education field

Regulatory

 

Purpose and necessity of education

Provide an overarching understanding of drug development and the steps from first in man to marketing applications focused on US FDA

·         Overview of drug development

·         Understand the various interfaces with FDA

·         Elements of INDs and NDAs and how to negotiate for success

·         Discuss regulations and implementation

 

Plan for Seminar

Time

Subject

Education Goal

Training content

 

09:00~09:30

Product Development

Gain an understanding of the stages of global pharmaceutical drug product development

·         Overview of the Drug Development milestones

·         Designing a target product profile that keeps the end in mind

·         Understanding the various stakeholders and their impact across the development lifecycle

How a defined product development strategy adds value to your investment and optimizes the development pathway

 

 

09:30~10:30

In the Spotlight: Food and Drug Administration (FDA) Guidance for Rare Disease Drug Development

Understand clinical, statistical and regulatory considerations for rare diseases

·         Important Clinical elements

·         Endpoints (including Surrogate Endpoints)

·         Natural History Studies

·         FDA guidance for Rare Diseases

Case studies

 

10:30~11:30

Creative Drug Development:
Understanding How to Leverage the Power of Statistics

Understanding when to leverage the power of statistics

·         Importance of Statistics in study design:

o   Defining trial objectives; study population; choice of endpoints; etc...

·         Framework for handling multiple endpoints for the go-to-market label

The value of Adaptive design approaches

 

11:30~12:00

 

First in Human Studies

Understanding early development and first in man requirements

·          FDA requirements and milestones GLP/GMP/GCPs

·          Non-clinical studies required for IND/NDAs

·          How to avoid clinical hold

 

 

12:00~13:00

 

 

The Role of Real World Data (RWD) and Real World Evidence (RWE) in Regulatory Submissions & Data Strategy

Understanding how Real World Data (RWD) and Real World Evidence (RWE) can play a role in Regulatory Submissions

On May 8, 2019, the FDA published  anew draft guidance for industry titled “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.” This draft guidance was produced as a joint effort from CDER and CBER and is intended to provide guidance about how to use Real World Data (RWD) and Real World Evidence (RWE) in regulatory submissions to the agency. This was an important first step and an endorsement from the agency that there is a place for RWD/RWE as an external control. Many view this as a paradigm shift and sets the stage for creative approaches to drug development. This is of particular interest to those developers of oncology, rare disease, and products that will require the acquisition of data remotely. We will focus on:

 

·         Understanding what is RWE/RWD?

·         Examining the FDA’s current thinking around RWE/RWD

How RWE and RWD can complement Randomized Clinical Trials (RCT) to create a more robust database

 

13:00 ~ 14:00     Lunch

14:00~14:30

 

 

Expedited Programs in the US

Understand qualifying criteria, features, and benefits of global expedited programs

·         Fast Track, BTD, RMAT,

PRIME, Conditional Approval, Accelerated assessment, Exceptional Circumstances

 

14:30~15:00

 

 

Expedited Programs in Europe

Understand qualifying criteria, features, and benefits of global expedited programs

·         Fast Track, BTD, RMAT,

PRIME, Conditional Approval, Accelerated assessment, Exceptional Circumstances

 

15:00~16:00

 

How to work with Regulators

FDA/EMA Interactions and interfaces

·         ·  FDA/EMA formal Meetings:

- Pre-IND, INTERACT, EOP2

-  EMA Scientific Advice, Protocol Assistance

·          Understanding and Addressing Agency Questions

·          Additional Mechanism:

-   CTAP

-   Special Protocol Assessments

-   Ad Com

 

16:00~17:00

 

 

 Marketing Applications

Understand the requirements for a successful Marketing Application

·         Marketing Application planning and Submission (case studies)

·         Peds requirements

Post Marketing Commitments

 

           


 


 

 

참고사항

*해당 교육은 모두 영어로 진행됨을 알려드립니다.

*본 강의는 임상시험종사자 교육으로 인정되지 않습니다.

*신청자가 많은 경우 기관별로 신청인원수를 제한할 수 있습니다.

 

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