Regulatory Affairs & Quality Advisory Board. A Parenteral Drug Association (PDA) Advisory Board

Transcription

1 Regulatory Affairs & Quality Advisory Board A Parenteral Drug Association (PDA) Advisory Board

2 Purpose of Presentation RAQAB has a goal of improving communication of RAQAB activities to the membership RAQAB Members will attempt to attend PDA Chapter meetings on an ongoing basis to provide updates on activities This first presentation is meant to introduce the Mission, Roles & Responsibilities of RAQAB, as well as introduce how members are selected 2

3 RAQAB Mission Statement The mission of the PDA Regulatory Affairs & Quality Advisory Board (RAQAB) is to serve the PDA membership by influencing scientific-based regulations and providing interpretation on quality and regulatory issues affecting the development, manufacturing and control of healthcare products This encompasses many areas including FDA, EMA, other global Regulatory Authorities and/or applicable bodies 3

4 RAQAB Role: What We Do The Regulatory Affairs and Quality Advisory Board (RAQAB): 1. Identifies current regulatory and quality issues affecting development, manufacturing and quality of healthcare products 2. Advises PDA on the impact of such issues 3. Recommends a plan of action for PDA response 4

5 What We Do (cont.) Typical issues may include evaluation of proposed regulations, technical guidance documents, inspection procedures, policy statements, Pharmacopoeia proposals, Standards activities and other related items developed by the e.g. US FDA, EMA, WHO, other global Regulatory Authorities and/or bodies As appropriate, the RAQAB develops and makes recommendations to PDA management on proposed Association positions 5

6 Where RAQAB Fits in PDA Structure 6

7 PDA Boards: The Roles Board of Directors Strategic direction for the Association and Foundation Three Advisory Boards to the BoD: 1. Regulatory Affairs and Quality Advisory Board (RAQAB) Serve membership by influencing scientific-based regulations and providing interpretation on quality and regulatory issues affecting development, manufacturing and control of healthcare products. 2. Science Advisory Board (SAB) Oversight for PDA's scientific and technical activities 3. Biotech Advisory Board (BioAB) Oversight for PDA's biopharmaceutical scientific and technical 7

8 RAQAB Membership RAQAB is led by a Chair and Co-Chair -Current Chair is Sue Schniepp -Current Co-Chair is Jeff Broadfoot The RAQAB Chair and Co-Chair are approved by the Board of Directors of PDA and assume the post for a period of three (3) years The RAQAB is comprised of up to 25 voting members This includes representatives to the following PDA functions: -Biotech Advisory Board Liaison -Science Advisory Board Liaison -Regional representatives (liaisons to certain regulatory areas of the world) 8

9 Regional Liaisons RAQAB is also represented by Regional Liaisons, who represent regions of the globe and provide expertise as to current events in those regions This includes: India China Canada United States Australia Russia Brazil 9

10 RAQAB Membership (Continued) RAQAB is also supported by non-voting PDA staff members and the leaders of the liaised PDA Interest Groups (IG) The regional Leaders, Advisory Board members and Liaison members each assume their positions for a period of three (3) years and are proposed by the RAQAB leadership team (Chair, Co-chair, past chair and PDA staff) Two (2) consecutive terms may be held following the PDA BOD procedure; the PDA IGs reporting to RAQAB are selected by the PDA Board of Directors 10

11 Member Selection Process 1. Assess the need for new RAQAB members -Prompted by expiration of specific terms, members resigning from advisory board or the need to expand the advisory board 2. Assessment process of potential new members: Commitment to PDA / volunteering e.g. length of membership, PDA activities experience, other outside experience Broad & diverse group of experts: By Expertise / Knowledge, By Region; By Employment (small and large firms; consultancies) 11

12 Member Selection Process (cont.) 3. Screening Process RAQAB Leadership team (Chair, Co-Chair, Immendiate Past Char & PDA Staff) review a pool of interested members Solicit updated information and confirm the candidates are still interested 4. Selection process RAQAB to approve the nomination of new member and returning members (vote taken) BoD to approve new chair/co-chair Approach individuals for RAQAB membership 12

13 Responsibilities & Expectations Participation in the RAQAB requires a commitment on the part of every member of the advisory board Much of the work undertaken by the RAQAB has very specific time constraints and requires adherence to strict schedules to ensure that comments are prepared, reviewed and approved in a timely manner for submission to Regulatory authorities and/or other bodies by specified deadlines 13

14 RAQAB Member Responsibilities Attendance/participation in RAQAB meetings 1. Face to Face Strategy Meetings (Target 2 times year, about 5 h; highly recommended) PDA Annual Meeting PDA/FDA Meeting PDA/EMA Meeting 2. Monthly Teleconferences (about 1.5 h; required unless time zone restrictions) 3. Ad-hoc Teleconferences, if/when applicable 4. Provide input & comments as part of RAQAB commenting process 5. Complete ballot once comments are completed 14

15 Questions/Contacts 15