2020-01-13T11:08:47-06:00 2019-06-30 260794367 UHY ADVISORS MID-ATLANTIC MD INC 8601 ROBERT FULTON DRIVE SUITE 210 COLUMBIA MD 21046 990 2018-07-01 541972348 PRODUCT QUALITY RESEARCH INSTITUTE PROD 2022305199 1500 K STREET NW NO 1100 WASHINGTON DC 20005 MEHRAN YAZDANIAN TREASURER 2022305199 2020-01-13 1 NANCY JOHNSON P01593478 4107205220 209.99.101.4 2020-01-13 11:08:16 ES P DA39A3EE5E6B4B0D3255BFEF95601890AFD80709 C10EB0FBAABFD2918ED9A76970A19A15359CB5C7 2018 2020-09-23 17:36:50Z MEHRAN YAZDANIAN 1500 K STREET NW NO 1100 WASHINGTON DC 20005 341726 0 X WWW.PQRI.ORG X 1999 VA TO GENERATE AND SHARE TIMELY, RELEVANT, AND IMPACTFUL INFORMATION THAT ADVANCES GLOBAL DRUG PRODUCT QUALITY, MANUFACTURING AND REGULATION. 5 5 0 90 0 0 40000 115000 169501 174225 13017 17707 554 1659 223072 308591 25000 0 0 0 0 0 0 0 0 239245 332206 264245 332206 -41173 -23615 576976 583541 28912 41856 548064 541685 X THE PRODUCT QUALITY RESEARCH INSTITUTE (PQRI) IS A NON-PROFIT CONSORTIUM OF ORGANIZATIONS WORKING TOGETHER TO GENERATE AND SHARE TIMELY, RELEVANT, AND IMPACTFUL INFORMATION THAT ADVANCES DRUG PRODUCT QUALITY, MANUFACTURING, AND REGULATION. PQRI PROVIDES A UNIQUE FORUM TO FOCUS CRITICAL THINKING, CONDUCT RESEARCH, EXCHANGE INFORMATION, AND PROPOSE METHODOLOGY OR GUIDANCE TO PHARMACEUTICAL COMPANIES, REGULATORS, AND STANDARD SETTING ORGANIZATIONS. 0 0 61591 PQRI SERVES AS A FORUM FOR ACADEMIA, INDUSTRY, AND REGULATORS TO WORK COOPERATIVELY TO CONDUCT PHARMACEUTICAL QUALITY RESEARCH AND TO SUPPORT THE DEVELOPMENT OF PUBLIC STANDARDS. PQRI IS COMPRISED OF THREE TECHNICAL COMMITTEES AND A STEERING COMMITTEE. THE STEERING COMMITTEE GUIDES AND DIRECTS THE SCIENTIFIC ACTIVITIES OF PQRI AND IS MADE UP OF 4 MEMBER ORGANIZATIONS REPRESENTING THE PHARMACEUTICAL INDUSTRY, TRADE ORGANIZATIONS AND REGULATORY AGENCIES. THE TECHNICAL COMMITTEES (DEVELOPMENT, BIOPHARMACEUTICS, AND MANUFACTURING) PROVIDE TECHNICAL AND SCIENTIFIC GUIDANCE, DIRECTION, AND REVIEW FOR THE PQRI WORKING GROUPS. THE TECHNICAL COMMITTEES CONSIST OF SCIENTISTS AND REGULATORY EXPERTS FROM MEMBER ORGANIZATIONS AND MAKE TECHNICAL/SCIENTIFIC RECOMMENDATIONS TO THE STEERING COMMITTEE. 117522 174225 PQRI WORKING GROUPS PERFORM RESEARCH MAINLY THROUGH DATA MINING, LABORATORY EXPERIMENTATION, AND INDUSTRY SURVEYS. 1412 RESEARCH:PQRI WILL GRANT RESEARCH FUNDS FOR THE CHPA PROJECT. A PROPOSED ASTM STANDARD (KW41534, TEST METHOD FOR ASSESSING RESTRICTED DELIVERY SYSTEMS FOR LIQUID CONSUMER PRODUCTS) AIMS TO PROTECT CHILDREN FROM ACCIDENTALLY INGESTING LIQUIDS FROM CONTAINERS SUCH AS MEDICINE BOTTLES THROUGH THE USE OF RESTRICTED DELIVERY SYSTEMS. RESTRICTED DELIVERY SYSTEMS ARE DESIGNED TO LIMIT ACCESS BY YOUNG CHILDREN, EVEN IF THE PRIMARY CHILD-RESISTANT CLOSURE IS NOT ENGAGED. FOR LIQUID PRODUCTS, THESE SYSTEMS TYPICALLY INCLUDE A COMPONENT, SUCH AS A FLOW RESTRICTOR, ADDED TO THE BOTTLE NECK TO RESTRICT THE RELEASE OF PRODUCT. THE PROJECT IS AN INTERLABORATORY STUDY TO ESTABLISH REPEATABILITY AND REPRODUCIBILITY OF THE TEST METHOD AND WILL TEST AT LEAST THREE DIFFERENT DESIGNS OF RESTRICTED DELIVERY SYSTEMS AND TO HAVE SIX LABS CONDUCT TESTING WITH PROVIDED SAMPLES. PQRI WILL DONATE FUNDS TO SUPPORT THE RESEARCH PROJECT FOR VALIDATION AND SUPPORT OF TOPICAL DRUG CLASSIFICATION SYSTEM. 179113 1 1 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 X 5 5 0 1 0 0 1 1 1 1 1 0 0 1 1 1 1 0 0 0 0 0 X X KIM ROUSE AT DRINKER BIDDLE 2028428800 1500 K STREET NW WASHINGTON DC 20005 X PEG SZYMCZAK THRU 119 CHAIR 3.00 X X 0 0 0 STEPHEN TYLER AS OF 219 CHAIR 3.00 X X 0 0 0 MEHRAN YAZDANIAN TREASURER 1.00 X X 0 0 0 TINA MORRIS DIRECTOR 1.00 X 0 0 0 JENNIFER AHEARN DIRECTOR 1.00 X 0 0 0 JOHN PUNZI DIRECTOR AS OF 04/19 1.00 X 0 0 0 0 0 0 0 0 0 0 DRINKER BIDDLE REATH LLP 1500 K STREET NW SUITE 1100 WASHINGTON DC 20005 MANAGEMENT SERVICES 165000 1 114000 1000 115000 REGISTRATION FEES 900099 174225 174225 174225 16567 16567 247 247 34275 33135 1140 1140 1140 UNSPENT AWARDS FOR RES 999999 1412 1412 1412 308591 175637 0 17954 165000 56100 108900 8175 2780 5395 989 989 2682 912 1770 700 238 462 32547 32547 117522 117522 4591 1561 3030 332206 179113 153093 0 32266 44137 4750 544710 534654 576976 583541 1412 27500 41856 28912 41856 X 529064 484685 19000 57000 548064 541685 576976 583541 -23615 19967 -2731 0 X X 0 1 X 1 0 X 114000 162750 117780 40000 115000 549530 329387 134560 259045 169501 174225 1066718 443387 297310 376825 209501 289225 1616248 114000 161750 116750 39000 114000 545500 0 114000 161750 116750 39000 114000 545500 1070748 8355 13573 13257 14066 16567 65818 8355 13573 13257 14066 16567 65818 451742 310883 390082 223567 305792 1682066 0.63660 0.61850 0.03910 0.04300 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 0 DUE TO DRINKER BIDDLE 41856 41856 X 325827 19967 19967 305860 2731 2731 308591 332206 0 332206 0 332206 PART X, LINE 2: THE INCOME TAX POSITIONS TAKEN BY PQRI FOR ANY YEARS OPEN UNDER THE VARIOUS STATUTES OF LIMITATIONS ARE THAT PQRI CONTINUES TO BE EXEMPT FROM INCOME TAXES AND THAT THEY HAVE PROPERLY REPORTED UNRELATED BUSINESS INCOME THAT IS SUBJECT TO INCOME TAXES. PQRI BELIEVES THAT THERE ARE NO TAX POSITIONS TAKEN OR EXPECTED TO BE TAKEN THAT WOULD SIGNIFICANTLY INCREASE UNRECOGNIZED TAX LIABILITIES WITHIN 12 MONTHS OF THE REPORTING DATE. NONE OF PQRI'S FEDERAL OR STATE INCOME TAX RETURNS ARE CURRENTLY UNDER EXAMINATION. FORM 990, PART VI, SECTION A, LINE 3 PQRI'S BOOKKEEPING IS HANDLED BY DRINKER BIDDLE, FOR WHICH A MANAGEMENT FEE IS PAID. FORM 990, PART VI, SECTION A, LINE 6 ALL CURRENT, DUES-PAYING MEMBERS SHARE THE SAME RIGHTS TO ELECT MEMBERS OF THE GOVERNING BOARD OR THEIR DELEGATES. FORM 990, PART VI, SECTION A, LINE 7A TWO OF THE FIVE BOARD MEMBERS MUST BE REPRESENTATIVES OF PQRI'S STEERING COMMITTEE. THE MEMBER ORGANIZATIONS OF THE PQRI STEERING COMMITTEE CONSIST OF GOVERNMENT ORGANIZATIONS AND NON-GOVERNMENT ORGANIZATIONS, AS THE PRQI STEERING COMMITTEE MAY ADMIT NON-GOVERNMENT ORGANIZATIONS WHO MUST BE NON-PROFIT, TAX EXEMPT ORGANIZATIONS WHO MUST INCLUDE AS A FOCUS OF THEIR MISSION AND THEIR ACTIVITIES THAT ADVANCE PHARMACEUTICAL SCIENCE, AMONG OTHER THINGS. FORM 990, PART VI, SECTION A, LINE 7B WHILE THE BOARD OF DIRECTORS HAS FULL AUTHORITY TO MAKE DECISIONS REGARDING FINANCIAL ASPECTS, PQRI'S STEERING COMMITTEE IS RESPONSIBLE FOR RECOMMENDING TO THE BOARD HOW ALL FUNDS ARE TO BE SPENT IN CONJUNCTION WITH SCIENTIFIC ACTIVITIES, SPECIFICALLY ALL RESEARCH DONE UNDER THE PURVIEW OF PQRI. FORM 990, PART VI, SECTION B, LINE 11B PQRI PROVIDES A COMPLETE COPY OF THE FORM 990 TO ALL MEMBERS OF THE GOVERNING BODY BEFORE IT IS FILED. FORM 990, PART VI, SECTION B, LINE 12C PQRI REGULARLY AND CONSISTENTLY MONITORS AND ENFORCES COMPLIANCE WITH THE CONFLICT OF INTEREST POLICY ON AN ANNUAL BASIS. FORM 990, PART VI, SECTION C, LINE 18 THE GOVERNING DOCUMENTS ARE AVAILABLE UPON REQUEST. FINANCIAL STATEMENTS ARE NOT MADE AVAILABLE TO THE PUBLIC. FORM 990, PART VI, SECTION C, LINE 19 THE GOVERNING DOCUMENTS AND CONFLICT OF INTEREST POLICY ARE AVAILABLE UPON REQUEST. FINANCIAL STATEMENTS ARE NOT MADE AVAILABLE TO THE PUBLIC. FORM 990, PART XII, LINE 2C PQRI'S BOARD OF DIRECTORS ASSUMES RESPONSIBILITY FOR OVERSIGHT OF THE AUDIT, INCLUDING SELECTION OF THE INDEPENDENT AUDITOR. THIS PROCESS IS CONSISTENT WITH PRIOR YEARS.