# Presentation: 018232

## The CDER 2001 

**Good Review Practices**

**Michael Ortwerth, Ph.D.**
**CDER GRP Project Coordinator**
**Center for Drug Evaluation & Research**
**Review Standards Staff**
**Food and Drug Administration**

- DIA 37th Annual Meeting
- Denver July 10th, 2001

**The CDER 2001 **
**Good Review Practices Initiative**
**A General Overview**

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## Presentation Outline

**Good Review Practices**

**Presentation Outline**

**Presentation Goal**
**Management**
**Policy**
**Objectives**
**Planning**
**Controls**
**Assurance**
**Improvements**

- 2

**Review Standards Staff**

## Presentation Goals

**Good Review Practices**

**Presentation Goals**

**Update external parties on the status of GRP efforts **
**Provide specific examples of GRP objectives**
**Obtain feedback and input on initiative planning**

- 3

**Review Standards Staff**

## GRP History

**Good Review Practices**

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**Review Standards Staff**

**GRP History**

- Smart Program, DFS, EES, OTCOM Established

**1995**

**1996**

- Reviews Evaluation Project - *Draft *ISS Guidance

**1997**

- Reviews Evaluation Steering Group - renamed -
-        Reviews Evaluation & Education Project

- GRP Clusters 1-5 Begin

**1998**

- The Clusters
- 1 - Define Good Review
- 2 - Obtain Buy-in
- 3 - Implementation
- 4 - Training
- 5 - Impact/External Evaluation

**2000**

- Pharm/Tox Review Format                    --*Draft*-Guidance produced

**2001**

- RSS Established

## Management

**Good Review Practices**

**Management**

**Centralized Center-level support for development **
**GRP Central Coordinating Committee**
**Project Coordinator Stewardship of:**
**Policy**
**Objectives**
**Planning**
**Controls**
**Assurance **
**Improvement**

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**Review Standards Staff**

## Policy

**Good Review Practices**

**Policy**

**Providing a multi-tiered and cross-disciplinary voice to the systemic planning, development, and assessment of GRP initiative projects **
**Fostering an evolving, learning, and participatory community in CDER that supports the continuous improvement of American health by approving drugs with the highest quality, safety, and efficacy**

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**Review Standards Staff**

## Objectives

**Good Review Practices**

**Objectives**

** ****Qualitative**
**Setting Standards**
**Consistent and uniform process planning and implementation**
**Process and product requirements**
**Assessment and improvement**

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**Review Standards Staff**

## Objectives - cont.

**Good Review Practices**

**Objectives - cont.**

**Quantitative**
** ****GRP Central Coordinating Committee**
** ****Review Templates and Executive Summary**
** ****Process Development Teams**
** ****GRP Intranet Web Page**
** ****Internal QA and audit functions**

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**Review Standards Staff**

**Notes:**
Review Templates and Executive Summary

1.  Leveraging information to support quality, safety, and efficacy

2.  Provide sponsors with a knowledge of application requirements

3.  Guide Reviewers to utilize the information provided by sponsors

GRP Web page

Workroom
Resource Room
Document Control
Dialog
Training

## Planning

**Good Review Practices**

**Planning**

**Systemic approach**
**Focus on functional feedback mechanisms**
**Standardized and centralized methodology (PDTs)**
**Risk Management of project barriers and root causes**
**Transparent development and documentation**

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**Review Standards Staff**

**Notes:**
Systemic Approach

(integration of CDER disciplines, clinical divisions, internal consultant and service functions, and management)

Functional feedback mechanisms
- one-on-one dialog
- small discussion groups
- larger forums and workships

Focus on functional feedback mechanisms  
one-on-one dialog
small discussion groups
larger forums and workshops

## Process Controls

**Good Review Practices**

**Process Controls**

**Internal transparent documentation of efforts met**
**Process Development Teams (PDT) established**
**PDT policy, objectives, and controls defined**
**PDT project outcomes reviewed by GRPCCC**

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**Review Standards Staff**

**Notes:**
Systemic Approach

(integration of CDER disciplines, clinical divisions, internal consultant and service functions, and management)

Functional feedback mechanisms
- one-on-one dialog
- small discussion groups
- larger forums and workships

Focus on functional feedback mechanisms  
one-on-one dialog
small discussion groups
larger forums and workshops

## Process Controls - cont.

**Good Review Practices**

**Process Controls - cont.**

**PDT products result in:**
**  ****>  Completion & compliance with applied time frames**
**  ****>  Measurable data in compliance with defined metrics**
**GRP Project Plan assessed internally and externally **

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**Review Standards Staff**

**Notes:**
Systemic Approach

(integration of CDER disciplines, clinical divisions, internal consultant and service functions, and management)

Functional feedback mechanisms
- one-on-one dialog
- small discussion groups
- larger forums and workships

Focus on functional feedback mechanisms  
one-on-one dialog
small discussion groups
larger forums and workshops

## Process/Product Assurance

**Good Review Practices**

**Process/Product Assurance**

**Peer-review of Process Development Team products**
**Internal Survey and Audit of product and product use**
**Post-Project Assessment Reports Completed**

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**Review Standards Staff**

**Notes:**
Systemic Approach

(integration of CDER disciplines, clinical divisions, internal consultant and service functions, and management)

Functional feedback mechanisms
- one-on-one dialog
- small discussion groups
- larger forums and workships

Focus on functional feedback mechanisms  
one-on-one dialog
small discussion groups
larger forums and workshops

## Improvements

**Good Review Practices**

**Improvements**

**Review of project control and assurance data**
**Project products evaluated for effectiveness of use:**
** ****Meeting user requirements**
** ****Obtaining feedback on product use**
**Develop potential improvement mechanisms**

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**Review Standards Staff**

**Notes:**
Systemic Approach

(integration of CDER disciplines, clinical divisions, internal consultant and service functions, and management)

Functional feedback mechanisms
- one-on-one dialog
- small discussion groups
- larger forums and workships

Focus on functional feedback mechanisms  
one-on-one dialog
small discussion groups
larger forums and workshops

## Acknowledgements

**Good Review Practices**

**Acknowledgements**

**Office of the Center Director - Dr. Woodcock**
**Review Standards Staff **
**    ****-  Lisa Rarick, M.D.; Judy McIntyre; Rubynell Jordan**
**Discipline GRP Contacts and Team Members**
**Center Offices, Divisions, and CDER Staff**

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**Review Standards Staff**

**Notes:**
Systemic Approach

(integration of CDER disciplines, clinical divisions, internal consultant and service functions, and management)

Functional feedback mechanisms
- one-on-one dialog
- small discussion groups
- larger forums and workships

Focus on functional feedback mechanisms  
one-on-one dialog
small discussion groups
larger forums and workshops