Tuesday, August 18, 2009

[EQ] A Scoping Literature Review of Collaboration between Primary Care and Public Health

A Scoping Literature Review of Collaboration between Primary Care and Public Health

A Report to the Canadian Health Services Research Foundation

Ruth Martin-Misener & Ruta Valaitis

April 21, 2009

Available online at: http://fhs.mcmaster.ca/nursing/docs/MartinMisener-Valaitis-Review.pdf

“….The purpose of this scoping review was to determine what is known from existing primary studies, literature reviews and descriptive accounts about:

• structures and processes required to build successful collaborations between Primary Care and Public Health

• outcomes of collaborations between Primary Care and Public Health

• markers of successful collaboration between Primary Care and Public Health…”

 

Contents

 Executive Summary

 Background

 Definition of Terms

 Purpose/Objectives

 Methods.

1 Overall Search Strategy

2 Electronic Databases

3 Website Search.

4 Hand-Searching of Key Journals.

5 Key Informants

6 Check of Reference Lists of Literature Reviews on PH and PC Collaboration

7 Inclusion / Exclusion Criteria and Review Process

8 Analysis.

Results.

1 Search Strategy Results

2 Overall Description of Relevant Papers.

3 Research Methods and Theories Used

4 Types of Collaboration

5 Precipitators of Collaboration

6 Key Health Issues Being Addressed.

7 Activities Carried Out in Collaborations

8 Barriers and Facilitators to Collaboration between PH & PC

9 Markers of Successful Collaboration between PH & PC

             10 Outcomes of Successful Collaboration between PH & PC

                             11 Negative Outcomes of

             12 Risks of Collaboration.

             13 Other Outcomes of Collaboration

Discussion

Recommendations

Appendix A: Website Hand Search

Appendix B: Extraction Form

 


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[EQ] CDER Forum for International Drug Regulatory Authorities

CDER Forum for International Drug Regulatory Authorities

October 5 - 9, 2009, Silver Spring, MD

International Programs -Center for Drug Evaluation and Research (CDER)

U.S. Food and Drug Administration

Website:  http://www.fda.gov/Drugs/NewsEvents/ucm167039.htm

 

 

We will place a greater emphasis on the regulatory review process and have added a panel of review discipline experts that will discuss a product review that is posted on Center for Drug Evaluation and Research  CDER’s DRUGS@FDA website. 

 

We will also have in depth presentations on drug product quality (both small molecule and biologics) and the GMP inspection process. 

 

The Center for Drug Evaluation and Research CDER values the Forum as a mechanism to meet Drug Regulatory Authorities from around the world.

 

Please forward this email to your colleagues who would benefit from our regulatory training. 

 

Please direct any questions to our CDER Forum mailbox:  cderforum@fda.hhs.gov .

Justina A. Molzon, M.S. Pharm, J.D. Associate Director for International Programs
Center for Drug Evaluation and Research (CDER)

U.S. Food and Drug Administration

 

 

Monday 05 October, 2009

Overview of Processes and Structure

 

8:30  – 9:00

REGISTRATION

9:00 – 10:00

CAPT Justina Molzon, M.S., Pharm, J.D.

Associate Director

International Programs

CDER FDA

Welcome and Introduction

Overview of the program and Participant Introductions

10:00 – 10:30

Walter Batts

Deputy Director

Office of International Programs

Office of the Commissioner

FDA

 

FDA’s International Program

 

Overview of FDA’s International Programs, including Organization, Activities and Foreign Offices

10:30 -10:45

BREAK

10:45 – 11:15

CDR Mary Kremzner, Pharm.D.

Associate Director

Div of Drug Information

CDER FDA

 

Role of CDER

Overview of the Process and Structure of CDER FDA including the Orphan drugs

11:15 – 12:15

CAPT Justina Molzon, M.S., Pharm, J.D.

Associate Director

International Programs

CDER FDA

 

ICH and the Common Technical Document

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

12:15 – 1:30

LUNCH on Your Own

 

OVERVIEW OF APPLICATIONS AND REVIEWS

1:30 – 2:15

Nancy Derr, M.A.

Policy Analyst Write Editor

Office of Regulatory Policy

CDER/FDA

 

Good Guidance Practices and  CDER’s Manual of Policies and Procedures

In 2000, GGPs became the law. This presentation reviews the development and implementation of good guidance practices at FDA.

2:15 – 3:00

Beth Duvall-Miller, B.S. Chem.

Team Leader Regulatory Affairs

Office of New Drugs

CDER FDA

 

Drug Development in the 21st Century: The Role of OND

Phases of Drug Development

OND’s organizational structure

OND’s role in the review process

21st Century Review Process

OND’s interactions with regulated industry

OND-led programs and initiatives

 

3:00 – 3:15

BREAK

3:15 – 4:00

Jayne Peterson

Advisors and Consultants

CDER FDA

 

Advisory Committees

Role of Advisory Committees in the drug review and approval process

4:00 – 4:30

CDR Rita Shapiro, M.A., D.P.T.

Office of Executive Programs

Div. of Training & Development

CDER FDA

 

Skill Building for Reviewers in CDER

The steps CDER takes to ensure appropriate training is provided to all reviewers at entry level as well as advanced updates.

4:30 – 5:00

Monica Unger, M.L.S.

Web Project Manger

Div. of Information Services

Office of Training and Communication, CDER FDA

 

CDER Public Transparency through WWW

An overview of CDER webpage on the FDA website and  information available to the public.

 

Tuesday 06 October, 2009

Review of New Molecular Entities

 

 

9:00 – 10:15

Ann Farrell, M.D.

Office of New Drugs

Div. of Drug Oncology Products

CDER FDA

 

Drug Review Process

An overview of safety and efficacy of  new drugs

10:15 – 10:30

BREAK

10:30 – 12:00

Renmeet Grewal, Pharm. D. – Project Management/Moderator

Audrey Gassman, M.D. – Med. Officer

Angelica Dorantes, Ph.D.

Daphne Ty Lin, Ph.D. – Statistician

Amy L. Ellis, Ph.D. – Pharm. Tox.

Cindy Kortepeter, Pharm. D. – Safety

Regulatory Drug Review: A panel of CDER Review Disciplines will discuss the drug review process

12:30 – 1:00

GROUP PHOTO

1:00 – 2:00

LUNCH on Your Own

2:00 – 2:45

Norman R. Schmuff, Ph.D.

Branch Chief

Office of New Drug Quality Assessment

Office of Pharmaceutical Science

CDER FDA

Quality Review (Chemistry)

A review of drug law and the quality controls with chemistry and manufacturing perspectives.

2:45 – 3:30

Patrick Swann, Ph.D.

Deputy Director

Div. of Monoclonal Antibodies

Office of Biotechnology Products

CDER FDA

Quality Review

(Biologics)

An overview of biologics quality review and regulation at CDER

3:30 – 4:15

Elizabeth Durmowicz, M.D.

Team Leader

Pediatric and Maternal Health

Office of New Drugs

CDER FDA

Specialty Reviews

(Pediatrics)

History of drug development in pediatric patients, pediatric legislation and outcomes of legislation

4:15-4:30

BREAK

4:30 – 5:30

CAPT Justina Molzon, M.S., Pharm, J.D.

Associate Director

International Programs

CDER FDA

Labeling Overview

A label for the drug as a result of the review process

 

Wednesday 07 October, 2009

Review of Over the Counter and Generic Drugs

 

9:00 – 9:45

Leah Christl, Ph.D.

Associate Director for Regulatory Affairs

Office of Non-prescription Products

CDER FDA

 

Regulation of Over-The-Counter (OTC) Drugs

How the OTCs are regulated and how the labeling of the OTCs is regulated to protect public health.

9:45 – 10:30

CDR Spencer Salis, Pharm. D.

Regulatory Operations Officer (OTC)

Div. of New Drugs and Labeling Compliance

Office of Compliance

CDER FDA

Overview of the OTC Drugs Team- Compliance Issues

An overview of OTC drugs enforcement and current OTC priorities

10:30 – 10:45

BREAK

10:45 – 12:15

Edward Sherwood

Management Analyst

Office of Pharmaceutical Science

CDER FDA

Overview of the Generic Drug Process 

Discussion on when generic drugs are eligible to enter the market and how CDER ensures that they are safe, effective and quality products

12:15 – 1:30

LUNCH on Your Own

1:30 – 3:00

Suhas Patankar, Ph.D.

Division of Chemistry

Office of Generic Drugs

Office of Pharmaceutical Sciences

CDER FDA

ANDA Review Process

CMC Perspective

Discussion will cover assessment of critical points addressed in Chemistry Manufacturing and Controls review of ANDAs, and Office of Generic Drug's new initiatives

3:00 – 3:15

BREAK

3:15 – 4:45

Leah N. Williamson, Ph.D.

Kuldeep R. Dhariwal, Ph.D.

Division of Bioequivalence

Office of Generic Drugs

CDER FDA

Bioequivalence Recommendations

Discussion will provide an Overview of Bioequivalence Testing in the U.S. for Generic Drugs

 

Thursday 08 October, 2009

Compliance

 

 

9:00 – 9:30

CAPT Jason J.Y. Woo, M.D.

Associate Director of Scientific and Medical Affairs

Office of Compliance, CDER, FDA

Compliance Overview

Overview of the Drug Lifecycle and role of Compliance in ensuring Drug Product Safety and Integrity, as well as impact of Globalization on drug regulation.

 

SCIENTIFIC INVESTIGATIONS

9:30 –10:15

Connie Lewin, MD

Medical Officer

Division of Scientific Investigations, Office of Compliance, CDER, FDA

Role of CDER in Bioresearch Monitoring Program

Description of FDA's Bioresearch Monitoring Program as carried out by CDER and how CDER assesses sponsor and clinical investigator compliance with pertinent regulations.

 

10:15 – 11:00

Jacqueline O'Shaughnessy, Ph.D.

Pharmacologist

Division of Scientific Investigations, Office of Compliance, CDER, FDA

Bioequivalence and Good Laboratory Practice

Overview of BE and GLP inspectional activities and their impact on the review process

11:00 – 11:15

BREAK

11:15 – 12:45

PANEL:  DIVISION OF NEW DRUGS and LABELING,  OFFICE of COMPLIANCE, CDER, FDA

 

Kathleen R. Anderson, Pharm. D.

Deputy Director

 

Elizabeth Miller, Pharm. D.

Pharmacist - Acting Team Leader Internet and Health Fraud Team

 

Karen Rothschild, Esq.

Regulatory Counsel

New Drugs and Labeling Team

 

Huascar Batista, M.P.H

Team Leader, Imports Exports Team,

 

Sudha Shukla, Pharm. D.

Pharmacist, Compounding Team

 

Overview

 

 

Internet and Health Fraud

 

 

New Drugs and Labeling

 

 

Imports Exports

 

 

Pharmacy Compounding

Overview of how FDA addresses and takes enforcement action against drugs marketed without FDA approval, including drugs sold via the internet, fraudulent drugs, prescription drugs, imported drugs, and compounded drugs.          

12:45-1:00             DNDLC Q & A

1:00 – 2:00                                                                                       LUNCH on Your Own

2:00 – 3:30                                 DIV. of Manufacturing and Product Quality,  Office of Compliance

 

 

Monica Caphart, M.S.

 

Colleen Hoyt

 

 

 

Yumi Hiramine

 

 

 

Israel Santiago

 

 

Douglas Campbell, B.S.

Case Management

 

Manufacturer Assessment & Pre-approval

 

International Compliance

 

Recalls, Shortages & Certificates

 

Inspectional Process

 

 

An overview of the roles and responsibilities of the FDA/CDER New, Generic and the Biotech Manufacturing Teams.

Overview of the roles/responsibilities of FDA/CDER International Compliance Team

An overview of the Recalls, Shortages and Certificates Branch and its functions

 

Quality System Approach to Inspections. Examples of records to review during inspections

3:30 –3:45

DMPQ:  Qs and As

 

 

 

Friday 09 October, 2009

Postmarketing

 

 

9:00 – 10:00

Gerald Dal Pan, M.D. M.H.S.

Director

Office of Surveillance and Epidemiology

CDER FDA

Overview of Drug Safety

An overview of drug safety with emphasis on public health

10:00-10:15

BREAK

10:15- 11:30

 

John Coburn

and

Suzanne Barone, Ph.D.

Div. of Compliance Risk Management and Surveillance

 

Compliance Risk Management and Surveillance

Drug Registration and Listing, Surveillance of Adverse Event Reporting, Drug Quality Reporting, and Risk Evaluation and Mitigation Strategies

 

11:30 – 1:00

LUNCH on Your Own

1:00 – 2:00

Gerald Dal Pan, M.D. M.H.S.

Director

Office of Surveillance and Epidemiology

CDER FDA

Overview of Drug Safety

How the drug safety is monitored and enforced in the market

2:00 – 2:15

BREAK

2:15 – 2:45

Barbara Chong, Pharm. D., BCPS

Team Leader

Div. of Drug Marketing, Advertising, and Communications

Office of Medical Policy

CDER FDA

Drug Marketing, Advertising, and Communications

 

An overview of the regulations pertaining to prescription drug promotion and recent enforcement actions

 

2:45 – 3:15

Denise Toyer, Pharm. D.

Div. of Medication Errors Prevention and Analysis

Office of Surveillance and Epidemiology

CDER FDA

Medication Errors

Medication errors reporting and subsequent management, review of MED-WATCH

3:15 – 4:30

OPEN FORUM Discussion by all Participants, Program Evaluation, Awarding Of Certificates and Review of the Contents on the Flash Drive à Farewell and future plans

 

 


Lou Valdez, MSM  Associate Commissioner for International Programs
Office of the Commissioner  U.S. Food and Drug Administration
Parklawn Building Room 15A-55
(301) 827-4480 Office  (301) 335-5562 BB


*      *      *     *
This message from the Pan American Health Organization, PAHO/WHO, is part of an effort to disseminate
information Related to: Equity; Health inequality; Socioeconomic inequality in health; Socioeconomic
health differentials; Gender; Violence; Poverty; Health Economics; Health Legislation; Ethnicity; Ethics;
Information Technology - Virtual libraries; Research & Science issues.  [DD/ KMC Area]

“Materials provided in this electronic list are provided "as is". Unless expressly stated otherwise, the findings
and interpretations included in the Materials are those of the authors and not necessarily of The Pan American
Health Organization PAHO/WHO or its country members”.
------------------------------------------------------------------------------------
PAHO/WHO website: http://66.101.212.219/equity/

Equity List - Archives - Join/remove: http://listserv.paho.org/Archives/equidad.html
Twitter http://twitter.com/eqpaho

 

    IMPORTANT: This transmission is for use by the intended recipient and it may contain privileged, proprietary or confidential information. If you are not the intended recipient or a person responsible for delivering this transmission to the intended recipient, you may not disclose, copy or distribute this transmission or take any action in reliance on it. If you received this transmission in error, please notify us immediately by email to infosec@paho.org, and please dispose of and delete this transmission. Thank you.