I
nvited Speaker:

Comparison of Dissolution Profiles, including Bioequivalence and F2 , Eastern Analytical Symposium, Somerset, NJ, USA, November 17, 2014.

Role of Dissolution Testing in Drug Development, Webinar for Mercer Pharmacy Students, May 28, 2014.

USP Anticipated Revisions to Dissolution General Chapter <711> and <1094> General Chapter on Capsules, Dissolution of Capsules Workshop, USP, Rockville, MD, USA, March 26, 2014.

Scientific Considerations using Similarity Factor, F2, AAPS Annual Meeting, San Antonio, TX, USA, November 12, 2013.

Design of Experiments (DoE) for the Dissolution Test Methodology and Detection of Critical Quality Attributes, Drug Development and Registration: Pharma-2020 Strategy Realization Conference, Moscow, Russia, October 29, 2013.

Gelatin Capsules: Current Issues when Cross-linking is Observed, Related to Addition of Enzyme to Media, Drug Development and Registration: Pharma-2020 Strategy Realization Conference, Moscow, Russia, October 29, 2013.

Need for harmonized IVIVC Guidances to Expedite Global Approvals, Annual Controlled Release Society, Honolulu, HI, USA, July 20, 2013.

Method Development and Setting Clinically Relevant Dissolution Specifications, Including Quality by Design, AAPS Workshop on Dissolution Testing and Bioequivalence, National University of La Plata, La Plata, Argentina, March 7, 2013.

Analytical issues Related to Enzymes Addition when Crosslinking Occurs, AAPS Annual Meeting, Chicago, IL, October 18, 2012.

Setting Clinically Relevant In Vitro Release Specifications for Controlled Release Products, Annual Controlled Release Society, Quebec City, Canada, July 14, 2012.

Report on Activities of USP Panels on Use of Enzymes in Testing Capsules that are Crosslinked, Challenges of Dissolution Testing Workshop, USP, Rockville, MD, June 11, 2012.

Comparison of Dissolution Profiles in Validation, Method Transfer and F2, presented at the AAPS-Rhodes University Dissolution Workshop, Grahamstown, South Africa, December 6, 2011

General Concepts:Design of Dissolution Method Development, including Quality by Design, presented at the AAPS-Sechenov First Moscow State Medical University Dissolution Workshop, Moscow, Russia, October 6, 2011.

GMP’s in the Dissolution Laboratory, including Preparing for a PAI, presented at the AAPS-Sechenov First Moscow State Medical University Dissolution Workshop, Moscow, Russia, October 7, 2011.

General Concepts__Design of Dissolution Method Development, including Quality by Design, presented at the AAPS-Croatian Pharmaceutical Society Dissolution Workshop, Zagrab, Croatia, October 3, 2011.

GMP’s in the Dissolution Laboratory, including Preparing for a PAI, presented at the AAPS-Croatian Pharmaceutical Society Dissolution Workshop, Zagrab, Croatia, October 4, 2011.

Recent Challenges in Dissolution Testing, Including USP Initiatives, Philadelphia Pharmaceutical Forum, April, 2011

Determining Similarity of Products- F2 Criterion and Variability of Dissolution Test, presented at the AAPS-Rhodes University Dissolution Workshop, Grahamstown, South Africa, December 10, 2009.

Trouble Shooting Dissolution Method Transfer Problems, presented at the AAPS-IPA workshop held in Bangalore, India, May 15, 2009.

Dissolution Regulatory GMP Issues, Including Preparing for a PAI, presented at the AAPS-IPA workshop held in Bangalore, India, May 16, 2009.

Dissolution Method Transfer, Including Sources of Problems, presented at the AAPS Annual Meeting, held in San Diego, CA, November 13, 2008.

Current Challenges in Dissolution Testing, including the Role of QBD, Philadelphia Pharmaceutical Forum, October 9, 2008

Dissolution Method Transfer, Including Sources of Problems. Presented at the AAPS Annual Meeting, San Diego, CA, November 13, 2007.

Dissolution Technology and Challenges for Novel Dosage Forms. Presented at the AAPS/SFDA Joint Conference, Hangzhou, China, July 2, 2007.

Overview of Dissolution Methods and Technologies. Presented at the AAPS/SFDA Joint Conference, Hangzhou, China, July 2, 2007.

Update on Emerging Trends on Quality by Design and GMP Issues. Presented at the IPA Conference on Dissolution Testing, Toronto, Canada, June 10, 2007.

Dissolution Method Development, Including Poorly Soluble Drugs and Novel Dosage Forms. A one-day course presented at the Eastern Analytical Symposium, Somerset, NJ, November 14, 2006.

Challenges to the Dissolution Method. Presented at the Tablets and Capsules Conference, Radison, NJ, October 10, 2006.

Challenges to the Dissolution Test, Including Performance Verification. Presented at the USP Annual Meeting, Denver, CO, September 29, 2006.

Challenges to Dissolution Testing, Including Calibration, Rebuttal, and Common Ground. Presented at the AAPS Workshop on Challenges for Dissolution Testing for the 21st Century, Arlington, VA, May 3, 2006.

Basic Dissolution Requirements. Presented at the AAPS Sunrise School at the AAPS Annual Meeting, Nashville, TN, November 9, 2005.

Future Challenges of the Dissolution Performance Test. Presented at the AAPS Roundtable Symposium at the AAPS Annual Meeting, Baltimore, MD, November 10, 2004.

Dissolution Method Development and Validation. Presented at the USP Annual Meeting, Iselin, NJ, September 28, 2004.

Design and Calibration of Dissolution Test Equipment. Presented at the FIP/WHO/CHINA Bioequivalence and Hands-On Dissolution Workshop, Beijing, China, April 12–13 and Shanghai, China, April 15–16, 2004.

Dissolution Testing with Fiber Optics: Industry Perspective on Regulatory Aspects. Presented at the AAPS Workshop on Dissolution: New Technology and Regulatory Initiatives, Bethesda, MD, March 30, 2004.

Dissolution Regulatory GMP Issues, Including Preparing for a PAI. Presented at the Dissolution, Bioequivalence and Bioavailability Conference, Philadelphia, PA, January 26, 2004.

Solubility Considerations in Dissolution Method Development. Presented at the Strategies for Improving Solubility Conference, Brussels, Belgium, October 3, 2003.

Dissolution Specifications Industry Update. Presented at the Dissolution, Bioequivalence, and Bioavailability Conference, Brussels, Belgium, October 3, 2003 and in Philadelphia, PA, January 26, 2004.

Method Validation in the Dissolution Lab. Presented at the Dissolution, Bioequivalence, and Bioavailability Conference, Brussels, Belgium, October 2, 2003.

Challenges of Developing Dissolution Methods and In Vivo–In Vitro Correlations for Poorly Soluble Drugs, Including a Discussion of Novel Dosage Forms. Presented at the Dissolution, Bioequivalence, and Bioavailability Conference, Philadelphia, PA, February 3, 2003, June 23, 2003, and in Brussels, October 3, 2003.

Dissolution Testing of Special Dosage Forms: Summary of FIP Workshops and Publication. Presented at the Dissolution Innovation Conference, Raleigh, NC, August 7, 2003.

Dissolution Testing with Fiber Optics: Regulatory Perspective and Evaluation Tips. Presented at the Dissolution Innovation Conference, Raleigh, NC, August 6, 2003.

Calibration and Qualification of Non-Compendial Dissolution Equipment, Including Sources of Error. Presented at the Dissolution Innovation Conference, Raleigh, NC, August 5, 2003.

Dissolution Regulatory GMP Issues. Presented at the International Pharmaceutical Academy Exposition, Toronto, Canada, September 24, 2002.

Calibration and Qualification—Mechanical and Tablet Calibration. Presented at the AAPS/FDA Workshop on Dissolution/In Vitro Release Testing and Specifications for Special Dosage Forms, Arlington, VA, September 16, 2002.

Challenges in Developing Dissolution Methods and In Vivo and In Vitro Correlations for Poorly Soluble Drugs. Presented at the 44th Annual International Industrial Pharmaceutical Research and Development Conference on Strategies for Formulating Poorly Soluble Drugs, Merrimac, WI, June 7, 2002.

Recent Trends and Initiatives in Dissolution, Including Calibration. Presented at the DDG (Dissolution Discussion Group), Chapel Hill, NC, May 23, 2002.

Oral Dosage Forms—General Considerations: Calibration and Qualification. Presented at Dissolution Testing of Special Dosage Forms Workshop sponsored by FIP, Frankfurt, Germany, March 5, 2001. (In collaboration with Mary Beggy, Robert Brockson, and Gina Stick)

Identifying Sources of Error and Variability and Sample Testing. Presented at a Dissolution Conference, Philadelphia, PA, February 27, 2001.

Encapsulated Tablets–Dissolution Testing Considerations. Presented at Dissolution Testing Conference, Vienna, VA, November 30–December 1, 2000. (In collaboration with John J. Mullen and Robert W. Brockson.)

Gelatin Cross-Linking in Capsules and Its Effect on Dissolution, Including a Case Study. Presented at Dissolution Testing Conference 2000, Philadelphia, PA. (In collaboration with Munir Hussain.)

Overview of Semi-Automated Equipment in a Dissolution Laboratory. Presented at ISLAR, Boston, MA, 1999. (In collaboration with Gina Leonard.)

Calibration of Apparatus I and II: What to do When Your Equipment Fails. Presented at Calibration and Validation Group, 1998.

What Dissolution Can Do for You. Presented at DuPont Pharmaceuticals Company, 1998.

USP Update: Chewable Tablets, Calibrator Tablets, Pooled Sampling, Two-Tier Testing, and Other Issues. Presented at Philadelphia Pharmaceutical Forum, 1997.

Capsules Two-Tier Dissolution Testing. Presented at AAPS Southeast Regional Meeting, 1997.

Extended Release Standards. Presented at Pharm Tech Conference, 1997.

Dissolution Calibrators. Presented at AAPS Short Course on Dissolution, 1996.

Dissolution Calibrators. Presented at Zentrallaboratorium Deutscher Apotheker, 1996.

Dissolution Calibrators. Presented at AAPS Dissolution Workshop, Crystal City, VA, 1995.

Podium Presentations – Co-Authorship:

Kim Huynh-Ba*, Anne Aubry, and Vivian Gray. Developing Dissolution Methods for Comparators. Presented at the AAPS Workshop on Dissolution: New Technology and Regulatory Initiatives, Bethesda, MD, March 31, 2004.

Robert Brockson* and Vivian Gray. Systematic Errors in Dissolution Testing and Analysis. Presented at Dissolution Discussion Group Symposium, Raleigh NC, May 2, 2001.

Copyright 2004. Property of V. A. Gray Consulting, Inc. All Rights Reserved.