Consultants
of the Biologics Consulting Group, Inc. attend several conferences
every year during which they are available to provide company information
or consulting expertise. BCG consultants often participate in continuing
educational conferences and product/service focused seminars. Below
are some conferences that BCG consultants will be attending in the
near future, or have attended in the past. Please feel free to contact
the attending consultant either before, or during the conference
for company information or to discuss a business opportunity. Also,
please see our Presentations page to view
a copy of BCG conference presentations.
Date
of Conference |
Organization
sponsoring conference |
Conference
& Presentation Title |
BCG
Consultant(s) Attending/Speaking |
Conference
Location |
| Feb 28-29, 2012 |
PTI |
CMC Analytical, Comparability and Stability Studies for Biotechnology Products |
Nadine
Ritter, Ph.D. |
Las Vegas, NV |
| March 19-22, 2012 |
Biotherapeutics Analytical Summit |
Biotherapeutics Analytical Summit
Short Course:
"Measurement, Characterization and Impact of Impurities" |
Nadine
Ritter, Ph.D.(instructor) |
Baltimore, MD |
| April 18-19, 2012 |
BioProcess International |
8th Annual Bioprocess International European Conference and Exhibition
Workshop on Extractables/Leachables in Biologics |
Nanda
Subbarao, Ph.D.(speaker) |
Prague, Czech Republic |
| May 10-11, 2012 |
IABS |
IABS Meeting
“Biomarkers in Inflammation” |
Norman Baylor, Ph.D.(session chair) |
Baltimore, MD |
| May 14-25, 2012 |
Fondation Merieux
|
ADVAC Advanced Coursed of Vaccinology
|
Norman Baylor, Ph.D.(lecturer) |
Annecy, France |
| May 20-23, 2012 |
AAPS |
AAPS National Biotechnology Conference
Subbarao:
Short course on Biosimilars:
"Challenges in Testing and Characterization of Bionanotherapeutics"
"Formulation Strategies for Nonparenteral Drug Delivery of Biotherapeutics"
"Physicochemical characterization of biosimilars" (speaker)
"Analytical comparability exercises for Biosimilars" (moderator/speaker)
-------------------------------------------------
Portnoy:
Session Title: "Product and Process Development Challenges for Prefilled Syringe and Injection Devices (#35)"
Presentation Title: "Biologic Prefilled Syringe and Injection Devices - Regulatory Challenges and Strategies"
|
Stuart Portnoy, MD(speaker)
Nanda
Subbarao, Ph.D.(moderator/speaker) |
San Diego, CA |
Past
Conferences Attended... |
| Dec 10-13, 2011 |
ASH |
2011 American Society of Hematology Annual Meeting and Exposition |
John Humphries, MD |
San Diego, CA |
| Nov 16-18, 2011 |
CHI |
3rd Annual Immunogenicity Summit
Presentation: “Recent Developments Concerning Sub Visible Particulate (SVP) Characterization for Biotech Products” |
Nadine
Ritter, Ph.D.(speaker)
Melanie Hartsough, PhD |
Bethesda, MD |
| Nov 15, 2011 |
Global Compliance Panel |
"Best practices for conducting OOS investigations" |
Nanda
Subbarao, Ph.D.(speaker) |
Webinar |
| Nov 9, 2011 |
CASSS |
Predictive Science of the Immunogenicity Aspects of Particles in Biopharmaceutical Products |
Nanda
Subbarao, Ph.D. |
Gaithersburg, MD |
| Nov 6-9, 2011 |
ACT |
2011 Annual Meeting
"Opportunities During Change: Advancing Your Toxicology Career in an Uncertain Market" |
David
J. Pepperl, Ph.D.
John
Jessop, Ph.D., MPH
Melanie Hartsough, PhD
(co-chair of continuing education course) |
Phoenix, AZ |
| Nov 8, 2011 |
Influenza Congress |
Influenza Congress 2011 |
Norman Baylor, Ph.D. |
Arlington, VA |
| Nov 1, 2011 |
MD&M |
MD&M (Medical Device and Manufacturing) Minneapolis 2011 Conference
“FDA 510(k) Changes: Impact on Preclinical Testing Requirements.” |
Stephen Rhodes, M.S.(speaker) |
Minneapolis, MN |
| Oct 31- Nov 1, 2011 |
CaSSS |
Bioassay Forum: Scientific Approaches and Regulatory Strategies |
Nadine
Ritter, Ph.D.(scribe) |
Bethesda, MD |
| Oct 26, 2011 |
Global Compliance Panel |
Equipment Qualification Program |
Nanda
Subbarao, Ph.D.(speaker) |
Webinar |
| Oct 23-26, 2011 |
RAPS (Booth #201) |
2011 Regulatory Affairs Professional Society: The Regulatory Convergence.
Drug Delivery Systems for Biologic Therapeutics -- Answers to Regulatory Questions
“Combination Product Regulation in the US Market Workshop: How to Tell Whether a Product is a Drug or a Device” |
Orest Hurko, MD
David Lin, Ph.D.
Stuart Portnoy, MD(session leader)
Kelly Reich, MS, RAC
Stephen Rhodes, M.S.(speaker)
Holli Vaughan, MS, RAC |
Indianapolis, IN |
| Oct 22-25, 2011 |
AABB
(trade association for transfusion and cell therapy industries) |
AABB Annual Meeting 2011 |
Joseph Fratantoni, MD (speaker) |
San Diego, CA |
| Oct 20-22, 2011 |
AMWA |
AMWA's 71st Annual Conference |
Calley Herzog |
Jacksonville, FL |
| Oct 20, 2011 |
Bioscience Forum |
Bioscience Forum
"Stem Cells: From Research to the Clinic" |
Alice Varga M.S., M.A (speaker) |
South San Francisco, CA |
| Oct 19-20, 2011 |
IPA Canada |
Pharmaceutical & Biopharmaceutical Stability |
David Lin, Ph.D.
(speaker) |
Montreal, Quebec, Canada |
| Oct 11-12, 2011 |
PTI |
2-Day Course Training:
CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products |
Nadine
Ritter, Ph.D.(trainer) |
London, UK |
| Oct 6, 2011 |
HBA |
Healtcare Businesswomen’s Association Meeting |
Alice Varga M.S., M.A (panel member) |
Berkeley, CA |
| Oct 5-6, 2011 |
MEDTEC Ireland |
"The 510(k) Premarket Notification Process and EU Medical Device Law: Current Status and Anticipated Changes" (Workshop chairperson")
Talk: "Changing FDA Regulatory Requirements for 510(k)s: Current Status and Future Directions"
Regulatory and Clinical Considerations for Product Developers" (Speaker)
Session: "Product Development and FDA Approval Process for Medical Devices" |
Miriam Provost, PhD (workshop chairperson/speaker) |
|
| Oct 3-5, 2011 |
IBC |
15th Annual Well-Characterized Biologicals: Practical Case Studies, Analytical Strategies, and Regulatory Perspectives
Presentation: “Common Mistakes Seen in Phase 1-2 CMC Studies” |
Nadine
Ritter, Ph.D.(chair and speaker) |
Washington, DC |
| Sep 27-28, 2011 |
Informa Life Sciences |
Workshops on Biosimilars and Extractables/Leachables in Biologics |
Nanda
Subbarao, Ph.D.
(speaker) |
Berlin, Germany |
| Sep 26, 2011 |
Japanese Society for Neurochemistry |
54th Annual Meeting of the Japanese Society for Neurochemistry |
Jim Kenimer, Ph.D. (speaker)
Orest Hurko, M.D.
(speaker)
|
Japan |
| Sep 20-21, 2011 |
IABS |
Reference Standards for Therapeutic Proteins: Their Relevance, Development, Qualification and Replacement |
Blair Fraser, Ph.D.
Nadine
Ritter, Ph.D. |
Bethesda, MD |
| Aug 31, 2011 |
BABCN |
Bay Area Biomedical Consultants’ networking talk and dinner |
Alice Varga M.S., M.A |
Millbrae, CA |
| Aug 22-25, 2011 |
Cambridge Healthtech Institute |
The Bioprocessing Summit: Practical Solutions for Today's Laboratory Challenges
"Stability Studies to support Comparability Studies" |
Nanda
Subbarao, Ph.D.
(speaker) |
Boston, MA |
| Aug 18, 2011 |
PDA (West Coast Chapter) |
PDA West Coast Chapter talk and dinner |
Alice Varga M.S., M.A. |
South San Francisco, CA |
| Aug 1-2, 2011 |
CaSSS |
Summer CMC Strategy Forum |
Nadine
Ritter, Ph.D.(trainer)
Ruth Wolff, Ph.D.
Vince Narbut |
Bethesda, MD |
| Jul 13-14, 2011 |
PTI |
2-Day Course Training:
QA and QC Compliance Strategies for Biopharmaceuticals Establishing, maintaining and remediating appropriate compliance strategies |
Tom Gerteisen Ph.D.(trainer) |
London, UK |
| Jun 27-30, 2011 |
BIO |
BIO 2011, booth #2953
Biotechnology Entrepreneurship Boot Camp |
Jim Kenimer, Ph.D. (speaker)
Debra Barngrover, PhD
Trent Carrier, PhD, MBA
Keith Wells, Ph.D.
Kelly Reich, MS, RAC
Kathleen Hewitt |
Washington, DC |
| Jun 27, 2011 |
BIO |
International InterconneXions at BIO 2011
“Early Preclinical Pharmacology-Toxicology Development of Biologics, Biopharmaceuticals and Drugs to IND Submission and Phase I Clinical Trial.” |
John
Jessop, Ph.D., MPH |
Washington, DC |
| Jun 23-25, 2011 |
Federation of Clinical Immunology Societies |
Federation of Clinical Immunology Societies Meeting |
Steve Litwin, M.D. |
Washington, DC |
| Jun 22-23, 2011 |
The Henry Kunkel Society |
Henry Kunkel Society Annual Meeting |
Steve Litwin, M.D. |
Washington, DC |
| Jun 19-22, 2011 |
DIA |
DIA 2011 Exhibition
"Novel Approaches for Nonclinical Testing of Biologic Products" |
David
J. Pepperl, Ph.D.
(speaker) |
Chicago, IL |
| Jun 12-15, 2011 |
Global Preclinical Training |
Study Directing- Principles and Practices
"How an FDA reviewer reads your reports" |
Melanie Hartsough, PhD
(speaker) |
Lake Tahoe, CA |
| Jun 8-9, 2011 |
Informa Life Sciences |
Non-Antibody
Protein Production
and
BIOSIMILARS
Pre-conference Workshop (June 7th):
Critical Analytical CMC Studies for Non-Antibody and Biosimilar
Products: Why, When, and How?
|
Nadine
Ritter, Ph.D.(Leader) |
Berlin, Germany |
| May 25-26, 2011 |
PTI |
Training Course:
Introduction to Biopharmaceutical Manufacturing Addressing critical elements in the manufacturing and regulation of biopharmaceutical products |
Ruth Wolff, Ph.D.(trainer) |
London, UK |
| May 18-21, 2011 |
ASGCT |
ASGCT 14th Annual Meeting |
Andra
Miller, Ph.D. |
Seattle, WA |
| May 19, 2011 |
State Food and Drug Administration, China |
State Food and Drug Administration, China
Training Course: ICH Quality Guidelines and FDA Guidances
|
David
Lin, Ph.D.(speaker) |
Beijing, China |
| May 18, 2011 |
PERI (The Pharmaceutical Education & Research Institute, Inc.) |
Biologics Drug Development: An Integrated Overview of Manufacturing, Non-Clinical, and Regulatory Requirements |
Orest Hurko, M.D.
(speaker) |
Arlington, VA |
| May 16-18, 2011 |
DIA |
3rd DIA China Annual Meeting
“Regulatory and Technical Challenges in Comparability Assessments” |
David
Lin, Ph.D.(session co-chair and speaker) |
Beijing, China |
| May 9-13, 2011 |
PEGS |
7th Annual PEGS
Short Course Title: Changing Guidances and Regulatory Expectations for Biologics
Talk Title: Challenges in Testing and Characterization of Bionanotherapeutics |
Julia Barrett, MD(speaker)
Nanda
Subbarao, Ph.D.
(speaker) |
Boston, MA |
| Apr, 29, 2011 |
Compliance Online |
Live Seminar:
Key GMP system for the lab |
Nanda
Subbarao, Ph.D.
(instructor) |
Philadelphia, PA |
| Apr 20, 2011 |
Compliance Online |
Why and How - Verification of Compendial Methods |
Nanda
Subbarao, Ph.D.
(instructor) |
Webinar |
| Apr 19, 2011 |
Global Compliance Panel |
Preparing for Pre-approval Inspections |
Nanda
Subbarao, Ph.D.
(instructor) |
Webinar |
| Apr 11-13, 2011 |
PDA |
Combination Products Interest Group |
Michael Gross, Ph.D.(group leader) |
San Antonio, TX |
| Apr 12-13, 2011 |
Informa Life Sciences |
Forced Degradation for Biologics |
Nadine
Ritter, Ph.D.(speaker) |
London, UK |
| Apr 4-6, 2011 |
DIA |
DIA workshop: Nonclinical and Clinical Strategies of First-in-Human Dosing of Large and Small Molecules
"Biopharmaceutical vs Small Molecule Nonclinical Development…Can You Spot the Differences?" |
Melanie Hartsough, PhD
(Program Chairperson and Co-chair of Nonclinical Development of Biopharmaceuticals) |
Washington, DC |
| Apr 4-5, 2011 |
Cambridge Healthtech Institute |
Characterization and Comparability for Biologics |
Nadine
Ritter, Ph.D.(Faculty) |
Bethesda, MD |
| Mar 30, 2011 |
Compliance Online |
Designing effective and efficient Extractables/leachables studies |
Nanda
Subbarao, Ph.D.
(instructor) |
Webinar |
| Mar 24, 2011 |
MDMA |
Premarket Approval (PMA) and 510(k) Premarket Notification Seminar
"Clinical Trial Considerations" |
Miriam Provost, PhD (speaker) |
Boston, MA |
| Mar 24, 2011 |
Global Compliance Panel |
Best practices for conducting OOS investigations |
Nanda
Subbarao, Ph.D.
(instructor) |
Webinar |
| Mar 22-23, 2011 |
PTI |
Training Course:
CMC Analytical, Comparability and Stability Studies for Biotechnology and Biosimilar Products |
Nadine
Ritter, Ph.D.(trainer) |
London, UK |
| Mar 22, 2011 |
MEDTEC Europe |
MEDTEC Europe Conference 2011
"View of FDA 510(k) Reform and Experience with the 510(k) Process" |
Miriam Provost, PhD (speaker) |
Stuttgart, Germany |
| Mar 21-22, 2011 |
PDA |
Solving Strategic Quality, Regulatory and Technical Issues During the Development of Prefilled Syringes, AutoInjectors and Injection Pens |
Michael Gross, Ph.D.(faculty) |
Bethesda, MD |
| Mar 10-11, 2011 |
PharmaEd |
Pre-Filled Syringes Forum 2011:
Strategic Development, Inspection, Safety & Regulatory Compliance and Commercialization
"Reporting Post-Approval Changes for Prefilled Injection Devices" |
Michael Gross, Ph.D.(speaker) |
Philadelphia, PA |
| Mar 6-10, 2011 |
Society of Toxicology (SOT) |
Annual Meeting & ToxExpo |
John
Jessop, Ph.D., MPH
David
J. Pepperl, Ph.D.
Melanie Hartsough, PhD |
Washington, DC |
| Feb 24-25, 2011 |
PharmaEd |
Conference on Transdermal Drug Delivery Systems
"FDA Regulation of Transdermal Drug Delivery Systems" |
Michael Gross, Ph.D.(speaker) |
Philadelphia, PA |
| Feb 23-24, 2011 |
PTI |
Course Training:
Introduction to Biopharmaceutical Manufacturing Addressing critical elements in the manufacturing and regulation of biopharmaceutical products |
Ruth Wolff, Ph.D.(trainer) |
London, UK |
| Feb 16-17, 2011 |
DIA |
Electronic Document Management 2011
The Intersection of Data, Documents,
and Submissions |
Dan Offringa
Ben Wimmer |
National Harbor, MD |
| Feb 7-10, 2011 |
University of Texas, College of Pharmacy |
International Conference on Drug Development
Presentation :”Comparative effectiveness research |
Orest Hurko M.D.(speaker) |
Austin, Texas |
Feb 7-9, 2011 |
DIA |
CMC Workshop: Translating Science into Successful Regulatory Submissions |
Blair Fraser, Ph.D.
David
Lin, Ph.D. |
Washington, DC |
| Feb 2-3, 2011 |
PTI |
Course Training:
QA and QC Compliance Strategies for Biopharmaceuticals Establishing, maintaining and remediating appropriate compliance strategies |
Ruth Wolff, Ph.D.(trainer)
Nadine
Ritter, Ph.D.(trainer) |
London, UK |
| Jan 24-26, 2011 |
Phacilitate |
Phacilitate Cell and Gene Therapy Forum 2011 |
Andra
Miller, Ph.D. |
Washington, DC |
| Jan 10-12, 2011 |
CASSS |
CASSS 24th CMC Strategy Forum & 15th WCBP Symposium
"Adventitious Agent testing the Evolving Reality (Potts)"
"The Importance of Classical Virology Training for Quality and Regulatory Staff in the Biopharmaceutical Industry (Potts)" |
Barbara Potts, Ph.D.(speaker)
Nadine
Ritter, Ph.D.(speaker)
Blair Fraser, Ph.D. |
Washington, DC |
| Dec 16, 2010 |
PhRMA |
PhRMA Influenza Vaccine Manufacturers meeting |
Michael S. Williams |
Bethesda, MD |
| Dec 13, 2010 |
CONNECT |
Creating and Leveraging a Technology Manufacturing Community Close to Home (Nearsourcing) |
Craig A. Halverson, M.S.(speaker) |
San Diego, CA |
| Dec 13, 2010 |
Johns Hopkins University Technology Transfer |
Johns Hopkins University Entrepreneurs’ Medical Device Tool Box Day |
Stephen Rhodes, M.S.(speaker)
Stuart Portnoy, MD (speaker) |
Baltimore, MD |
| Dec 7-9, 2010 |
CBI |
Stability Programs Forum
“Stability Testing for Biotechnology/Biologic Products” |
David
Lin, Ph.D.
(speaker) |
Philadelphia, PA |
| Dec 4-7, 2010 |
American Society of Hematology |
Annual Meeting |
Joseph Fratantoni, MD |
Orlando, FL |
| Nov 16-19, 2010 |
Informa Life Sciences |
11th Annual EuroTIDES 2010
"Peptides and Stability Testing Requirements" |
David
Lin, Ph.D.
(speaker) |
Barcelona, Spain |
| Nov 15-17, 2010 |
Informa Life Sciences |
Regulatory Affairs for Biopharmaceuticals
Workshop: "CMC Regulatory Compliance for Biopharmaceuticals" |
Nadine
Ritter, Ph.D.(speaker) |
Berlin Germany |
| Nov 15-16, 2010 |
APEC |
2010 AHC Workshop on Medical Devices – Use of Clinical Evidence |
Stephen Rhodes, M.S.(speaker) |
Seoul, Korea |
| Nov 14-18, 2010 |
AAPS |
Annual Meeting |
Nadine
Ritter, Ph.D. |
New Orleans, LA |
| Nov 8-9, 2010 |
CaSSS |
2nd Annual Bioassays 2010: Scientific Approaches and Regulatory Strategies |
Nadine
Ritter, Ph.D.(speaker) |
Bethesda, MD |
| Nov 7-8, 2010 |
American College of Toxicology (ACT) |
31st Annual Meeting |
John
Jessop, Ph.D., MPH |
Baltimore, MD |
| Nov 3, 2010 |
Exponent |
Changes in the 510(k) Process: A Look into the Crystal Ball |
Miriam Provost, PhD (speaker) |
Philadelphia, PA |
| Oct 27-29, 2010 |
|
World Drug Discovery and Development Summit 2010 |
Orest Hurko M.D.(speaker) |
Copenhagen, Denmark |
| Oct 27-28 2010 |
Informa Life Sciences |
BioProduction 2010 |
Nanda
Subbarao, Ph.D.
(speaker) |
Barcelona, Spain |
| Oct 25-27, 2010 |
PDA |
PDA’s 5th Annual Global Conference on Pharmaceutical Microbiology
“The Myths of Virology and Mycoplasmology”
PDA Mycoplasma Filtration class |
Barbara Potts, Ph.D.(speaker) |
Washington, DC |
| Oct 24-27 2010 |
RAPS |
Annual Conference and Exhibition |
Andra
Miller, Ph.D.
Blair Fraser, Ph.D.
Barbara Potts, Ph.D.
Darin
Weber, Ph.D.
Stephen Rhodes, M.S.
Ron Marchesani
Calley Herzog
Craig Halverson, M.S.
(speakers) |
San Jose, CA |
| Oct 21-24, 2010 |
Chinese Pharmaceutical Enterprises Association |
International Summit of China Pharmaceutical Industry
“FDA Requirements for Peptide Product Development: Considerations from Small Molecule and Biological Products” |
David
Lin, Ph.D.
(speaker) |
Hangzhou, China |
| Oct 20-22, 2010 |
IBC |
Well Characterized Biopharmaceuticals: 14th Annual Meeting |
Nadine
Ritter, Ph.D.(speaker) |
Bethesda, MD |
| Oct 19-20, 2010 |
International Pharmaceutical Academy (IPA) |
Advances and Efficiencies in Stability Testing for the Pharmaceutical & BioTech Industry |
Nanda
Subbarao, Ph.D.
(speaker) |
Montreal, Canada |
| Oct 19, 2010 |
WuXi Apptec |
Virus Safety in Biopharmaceuticals |
Barbara Potts, Ph.D.(speaker) |
South San Francisco, CA |
| Oct 14-15, 2010 |
Informa PTI-UK |
Training Class: CMC Analytical, Comparability and Stability Studies for Biotechnology Products |
Nadine
Ritter, Ph.D.(instructor) |
London, UK |
| Oct 12, 2010 |
Medical Design & Manufacturing (MD&M) |
510(k) Reform: Impact on preclinical testing requirements |
Miriam Provost, PhD (speaker) |
Minneapolis, MN |
| Oct 9-12, 2010 |
AABB |
Annual Meeting & TXPO |
Joseph Fratantoni, MD |
Baltimore, MD |
| Sep 29-Oct 1, 2010 |
BEBPA (Biopharmaceutical Emerging Best Practices Association) |
Annual BEBPA Bioassay meeting
"Quality Practices in Bioassay Labs: R&D, GLP or GMP?” |
Nadine
Ritter, Ph.D.(speaker) |
Barcelona, Spain |
| Sep 20-24, 2010 |
IBC |
IBC BioProcessing International Conference
“Global Adventitious Agent Regulations of Raw Materials Used in Biopharmaceutical Manufacturing” |
Barbara Potts, Ph.D.(speaker) |
Providence, RI |
| Sep 13-15, 2010 |
PDA |
Annual Conference/Joint Task Force Meeting |
Nadine
Ritter, Ph.D.(speaker) |
Washington, DC |
| Aug 1-6, 2010 |
ACS |
Recovery of Biological Products XIV
Session: QbD in practice – Reconciling regulators expectations and industry implementation |
Nadine
Ritter, Ph.D.(speaker) |
Lake Tahoe |
| July 28-30, 2010 |
IVT |
7th Annual Method Validation
“Ensure Method Validation Compliance through a Review of FDA Warning Letters”
“Setting Biological Product Specifications” |
David
Lin, Ph.D.
(speaker) |
San Francisco, CA |
| Jul 19-20, 2010 |
CaSSS |
CMC Strategy Forum-US: QbD for Biologics: Learning’s from the Product Development and Realization Case Study and the FDA Pilot Program |
Nadine
Ritter, Ph.D.(speaker) |
Bethesda, MD |
| Jun 16-19, 2010 |
International Society for Stem Cell Research |
International Society for Stem Cell Research 8th Annual Meeting |
Barbara Potts, PhD |
San Francisco, CA |
| June 15, 2010 |
International Society for Stem Cell Research |
ISSCR/CIRM/ISCT Regulatory Workshop: Stem Cell Therapies in Clinical Trials – Best Practices and the Need for Harmonization |
Darin
Weber, Ph.D. (speaker) |
San Francisco, CA |
| Jun 14-15, 2010 |
USP |
Bioassay Workshop |
Nadine
Ritter, Ph.D. |
Rockville, MD |
| June 3-10, 2010 |
Cord Blood Forum |
International Cord Blood Transplantation Symposium |
Ellen
M. Areman, MS, SBB |
San Francisco, CA |
| June 5, 2010 |
Chinese American Biopharmaceutical Society |
Regulatory and QA Considerations for Drug Product Development |
Louise Johnson |
Foster City, CA |
| May 26, 2010 |
BenAstrum |
Preparing for FDA GLP Audits |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar |
| May 25, 2010 |
BenAstrum |
Analytical CMC Studies for Biotechnology Products: ICH CTD Requirements |
Nadine
Ritter, Ph.D.(instructor) |
Webinar |
| May 17-19, 2010 |
PDA |
Vaccines conference |
Jim Kenimer, Ph.D. (moderator)
Peter Patriarca (presenter)
Ann Sutton |
Bethesda, MD |
| May 16-19, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
National Biotechnology Conference
Hot Topic Session: Risk-Based Product Development CMC Strategies: Pay Me Now or Pay Me Later! |
Nadine
Ritter, Ph.D.(speaker) |
San Francisco, CA |
| May 12-14, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
AAPS National Biotechnology Conference: Stability of Novel Biological Products |
Nanda
Subbarao, Ph.D.
(moderator) |
San Francisco, CA |
| May 12-14, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
AAPS National Biotechnology Conference: ‘You are manufacturing protein from – What?! Novel expression systems.’ |
Nanda
Subbarao, Ph.D.
(moderator) |
San Francisco, CA |
| May 12-14, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
AAPS National Biotechnology Conference: The Heparin Contamination Incident-what We Have Learnt from it |
Nanda
Subbarao, Ph.D.
(moderator) |
San Francisco, CA |
| May 12-14, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
AAPS National Biotechnology Conference: Extractables and Leachables in Biologics |
Nanda
Subbarao, Ph.D.
(speaker) |
San Francisco, CA |
| Apr 29, 2010 |
Compliance Online |
Testing for Particulates in Biologics |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar, 10:00am PST |
| Apr 28, 2010 |
BenAstrum |
An FDA Perspective on Analytical Method Validation |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar |
| Apr 26-28, 2010 |
CaSSS |
EU CMC Strategy Forum: Challenges Facing Biopharmaceutical Development in the Next Decade |
Nadine
Ritter, Ph.D.(speaker) |
Vienna, Austria |
| Apr 22, 2010 |
PDA Mycoplasma Task Force Filtration sub group |
Consensus rating for evaluating filters for the removal of mycoplasma. |
Barbara Potts, PhD
(training co-leader) |
Frankfurt, Germany |
| Apr 20-21, 2010 |
PDA |
2010 PDA Workshop on the Impact of Bio-Films on Pharmaceutical and Biopharmaceutical Manufacturing |
Barbara Potts, PhD
(co-chair) |
Frankfurt, Germany |
| Apr 20, 2010 |
BenAstrum |
Selection and Validation of Test Methods for Host Cell Proteins |
Nadine
Ritter, Ph.D.(instructor) |
Webinar |
| Apr 13-14, 2010 |
Informa Life Sciences |
Forced Degradation for Biologics |
Nadine
Ritter, Ph.D. |
Danubius Regent’s Park Hotel
London, UK |
| Apr 9, 2010 |
BenAstrum |
Annual GLP Training |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar, 8:45 am -11 am, EST |
| Apr 8, 2010 |
Compliance Online |
Why we need an effective Equipment Program? Implement USP <1058> |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar, 10:00am PST |
| Apr 7, 2010 |
BayBio |
BAYBIO2010 Life Sciences Innovation: Drivers and Barriers |
Barbara Potts, PhD |
Burlingame, CA |
| Mar 30, 2010 |
BenAstrum |
Recent Developments in the WHO Vaccine Stability Guidance – Key Definitions |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar 1:15 pm- 3.30 EST |
| Mar 25-26, 2010 |
Informa PTI-UK |
Training Class: CMC Analytical, Comparability and Stability Studies for Biotechnology Products |
Nadine
Ritter, Ph.D.(instructor) |
Regus St James's Park, London, UK |
| Mar 24, 2010 |
BenAstrum |
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar |
| Mar 22, 2010 |
Compliance Online |
How to comply with recent expectations for extractables /Leachables testing for Biologics |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar, 10:00am PST |
| March 17, 2010 |
BenAstrum |
Preparing for FDA GLP Audits |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar |
| March 15, 2010 |
BenAstrum |
Comprehensive Forced Degradation Studies to Validate Stability–Indicating Methods for Biotechnology Products |
Nadine
Ritter, Ph.D.(instructor) |
Webinar |
| Mar 15-19, 2010 |
PDA |
2010 PDA Annual Meeting
"Update on the Activities of the Mycoplasma Task Force" |
Barbara Potts, PhD
(speaker) |
Orlando, FL |
| Mar 8 - 10, 2010 |
AABB/FDA |
Cord Blood Licensure: A Workshop |
Ellen
M. Areman, MS, SBB(speaker/moderator) |
Rockville, MD |
| March 9 - 10, 2010 |
AAPS
(Amercian Association of Pharmaceutical Scientists) |
AAPS National Biotechnology Conference Programming Committee 2011 Jamboree |
Nanda
Subbarao, Ph.D.
(regulatory sciences section leader ) |
Chicago, IL |
| Feb 3-5, 2010 |
Pharma Conference |
6th Annual FDA and the Changing Paradigm for HCT/P Regulation
"Labeling for HCT/Ps – Convergence or Divergence?" |
Darin
Weber, Ph.D. (speaker) |
Orlando, FL |
| Feb 2-5, 2010 |
DIA |
Generating and Weighing Evidence in Drug Development and Regulatory Decision Making
"Development of an IVD with Approved Drugs" |
Ron Salerno, PhD
session chair |
Bethesda, MD |
| Jan. 25-27, 2010 |
Phacilitate |
Vaccine Forum Washington 2010 |
Michael L. Salgaller, PhD |
Washington, DC |
| Jan. 24-27, 2010 |
CaSSS |
CMC Strategy Forum/WCBP Industry-FDA meeting |
Nadine
Ritter, Ph.D.(speaker) |
Washington, DC |
| Jan. 12-13, 2010 |
EBD Group/Demy-Colton |
Biotech Showcase 2010 |
Michael L. Salgaller, PhD
Ron Marchesani |
San Francisco, CA |
| Jan. 12-13, 2010 |
CHI Peptalk |
Enabling Analytical Methods for Extractables and Leachables Testing for Biologics |
Nanda
Subbarao, Ph.D.
(speaker) |
San Diego, CA |
| Jan. 12-13, 2010 |
CHI Peptalk |
Characterization and Analysis of Particulates: Methods and Tools |
Nanda
Subbarao, Ph.D.
(speaker) |
San Diego, CA |
| Dec. 5-8, 2009 |
American Society of Hematology |
51st ASH Annual Meeting and Exposition |
Joseph Fratantoni, MD
John Humphries, MD |
New Orleans, LA |
| Dec. 3-4, 2009 |
FasterCures |
Partnering for Cures |
Michael L. Salgaller, PhD |
New York, NY |
| Nov. 12-13, 2009 |
IBC Life Sciences |
De-Risking Next Generation Biologics
De-Risking Next Generation Biologics
Risking Next Generation Biologics
|
Blair Fraser, Ph.D.
(speaker) |
Bethesda, MD |
| Nov. 12, 2009 |
BenAstrum |
Clinical Product Development: From Pre-IND to BLA/NDA |
Julia Barrett, MD
(course instructor) |
Webinar (1:20-3:15 EST) |
| Nov. 11-12, 2009 |
IBC Life Sciences |
GLPs and GMPs for Biopharmaceutical Development |
Nanda
Subbarao, Ph.D.
(course instructor) |
San Francisco, CA |
| Nov. 10, 2009 |
BioWest |
Annual Meeting (Booth #34) |
Julia Barrett, MD
Calley Herzog
Michael Salgaller, Ph.D.
Ann Sutton
Annie Zurbay |
Denver, CO |
| Nov. 9-11, 2009 |
IBC Life Sciences |
Well Characterized Biologicals |
Nadine
Ritter, Ph.D.(chairperson) |
Bethesda, MD |
| Nov. 9-10, 2009 |
IBC Life Sciences |
Forced Degradation studies for Biopharmaceuticals |
Nanda
Subbarao, Ph.D.
(course instructor) |
San Francisco, CA |
| Nov. 4-6, 2009 |
BioFlorida |
12th Annual Conference |
Michael Salgaller, Ph.D.
Holly Scott |
Orlando, FL |
| Nov. 4-6, 2009 |
Mid-Atlantic BIO |
2009 Mid-Atlantic Bio |
Jim Kenimer, Ph.D. |
Washington, DC |
| Nov. 1-4, 2009 |
American College of Toxicology (ACT) |
30th Annual Meeting |
Melanie Hartsough, PhD
John
Jessop, Ph.D., MPH |
Palm Springs, CA |
| Oct. 28-31, 2009 |
iSBTc (International Society for the Biological Therapy of Cancer) |
2009 Annual Meeting |
Michael Salgaller, Ph.D. |
Washington, DC |
| Oct. 26-29, 2009 |
Seton Hall Law School |
Health Care Compliance Certification Program
"Advertising & Promotion of Medical Devices" |
Stuart Portnoy, MD (speaker) |
New Brunswick, NJ |
| Oct. 26, 2009 |
|
FDA Immunotoxicology Forum |
Melanie Hartsough, PhD
John
Jessop, Ph.D., MPH |
Silver Spring, MD |
| Oct. 24-27, 2009 |
AABB (American Association of Blood Banks) |
Annual Meeting & TXPO
Validation Rules & Regs: How do they apply to me?
|
Joseph Fratantoni, MD
Ellen
M. Areman, MS, SBB
(moderator) |
New Orleans, LA |
| Oct. 7-10, 2009 |
Biomedical Engineering Society (BMES) |
BMES 2009 Annual Fall Scientific Meeting
"Translational Bioengineering: Overcoming the Ultimate Barrier to
Entry: Commercialization, Regulation, and the FDA" |
Ian Millett, Ph.D.
(speaker) |
Pittsburgh, PA |
| Oct. 7, 2009 |
Colorado State University BioMARC (Biopharmaceutical Manufacturing & Academic Resource Center) |
Navigating Clinical Trials |
Julia Barrett, MD
(course instructor) |
Loveland, CO |
| Oct. 1-2, 2009 |
IBC Life Sciences |
GLPs and GMPs for Biopharmaceutical Development |
Nanda
Subbarao, Ph.D.
(course instructor) |
Boston, MA |
| Sept. 30 - Oct. 2, 2009 |
Roche Colorado |
Roche Colorado Corporation Peptide Symposium |
Blair Fraser, Ph.D.
(speaker) |
Boulder, CO |
| Sept. 29-30, 2009 |
IBC Life Sciences |
Forced Degradation studies for Biopharmaceuticals |
Nanda
Subbarao, Ph.D.
(course instructor) |
Boston, MA |
| Sept. 28, 2009 |
DIA |
Biosimilar Workshop |
John
Jessop, Ph.D., MPH |
London, UK |
| Sept. 24-25, 2009 |
AAPS (American Association of Pharmaceutical Scientists) |
Current Trends in Stability
"Stability requirements for Biologics" |
Nanda
Subbarao, Ph.D.
(speaker/moderator) |
National Harbor, MD |
| Sept. 21-23, 2009 |
Genetics Policy Institute |
World Stem Cell Summit |
Ellen
M. Areman, MS, SBB
|
Baltimore, MD |
| Sept. 16-17, 2009 |
PDA |
PDA Combination Products Workshop
"Status of Current Regulatory Frameworks and Perceived Problems" (Gross)
"Plenary Session 6 - Safety Reporting" (Portnoy) |
Michael Gross, Ph.D. (speaker)
Stuart Portnoy, MD (speaker) |
Washington, DC |
| Sept. 13-16, 2009 |
RAPS |
Annual Conference - Booth #520
"Implementation of the Case-by-Case Approach: Practical Applications" (Hartsough)
"Combination Products & Cross Labeling -- Fact or Fiction?" (Portnoy)
"Navigating the Scientific and Regulatory Dividing Line Between Drugs and Devices" (Provost)
"Tissue Engineered Combination Products— Coordination Is Key" (Provost) |
Melanie Hartsough, PhD (speaker)
Calley Herzog
Ian Millett, PhD
Stuart Portnoy, MD (speaker)
Miriam Provost, PhD
(speaker/chairperson)
Michael
Trapani, MS, MBA
Kelly Reich, MS
Holli Vaughan, MS, RAC |
Philadelphia, PA |
| Sept. 12-13, 2009 |
SEAK, Inc. |
National Non-Clinical Careers For Physicians
"Networking Your Way Into a Non-Clinical Career:
Industry, Government & Consulting" |
Stuart
Portnoy, MD
(speaker) |
Chicago, IL |
| Sept. 9, 2009 |
BenAstrum |
USP – Chapter 467 & GMP Requirements for Testing Residual Solvents |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar
1:00-4:00pm EDT |
| Sept. 8-9, 2009 |
IIR |
Stability Testing for Biologics
"Stability Testing Performed Over A Product Lifecycle" |
David
Lin, Ph.D.
(speaker) |
Prague, Czech Republic |
| Aug. 19-21, 2009 |
IVT (Institute of Validation Technology) |
8th Annual Laboratory Compliance Week
"Develop Effective Stability Testing of New Drug Substances and Products" (Lin)
Handling OOS/OOT Results and Failure Investigations Workshop (Subbarao) |
David
Lin, Ph.D.
(speaker)
Nanda
Subbarao, Ph.D.
(speaker) |
Philadelphia, PA |
| Aug. 17-18, 2009 |
Cambridge Healthtech Institute |
Production & Manufacturing of Vaccines (part of the ImVacs Immunotherapeutics & Vaccine Summit)
"Essential Quality Considerations for Today’s Manufacturing of Vaccines: The Do’s and Don’ts for Successful Audits and Inspections" |
Ron Marchesani
(speaker) |
Providence, RI |
| July 29-30, 2009 |
PDA |
PDA Cell Substrate Workshop |
T.W. Tanaka (speaker) |
Bethesda, MD |
| July 16, 2009 |
BenAstrum |
Comprehensive Forced Degradation Studies to Validate Stability–Indicating Methods for Biotechnology Products |
Nadine
Ritter, Ph.D.(speaker) |
Webinar
1:20-3:45pm EDT |
| July 16, 2009 |
PACT (Production Assistance for Cellular Therapies) / NHLBI |
Deviation Management of Type 351 & 361 Cell Products |
Ellen
M. Areman, MS, SBB
(speaker)
|
Webinar
12:00 EDT |
| July 16, 2009 |
Compliance Online |
The Pre-IND Process: Changes in Working with the FDA and Regulatory Procedures. |
David
J. Pepperl, Ph.D. (speaker) |
Webinar
1:00-2:30 pm EDT |
| July 15, 2009 |
RAPS |
RAPS Business and Leadership Series: Outsourcing |
David
J. Pepperl, Ph.D. (speaker)
Michael
Trapani, MS, MBA
(speaker) |
Webcast 12:00–1:30 pm |
| July 13-16, 2009 |
ISTH (International Society on Thrombosis and Haemostasis) |
ISTH 2009 Congress
"Efficacy of Full-length Recombinant Human Plasmin in a Porcine Model of Arteriovenous Graft Thrombosis " |
John Humphries, MD
(speaker) |
Boston, MA |
| July 8, 2009 |
BenAstrum |
Recent Developments in the WHO/ASEAN Stability Guidance |
Nanda
Subbarao, Ph.D.
(speaker) |
Webinar 1:00–4:00 pm |
| Jun. 25-26, 2009 |
IIR-PTI |
CMC Analytical, Comparability and Stability Studies for Biotechnology Products
"Current Expectations, Practical Considerations” |
Nadine
Ritter, Ph.D.(speaker) |
London , UK |
| Jun. 22-24, 2009 |
American Association of Pharmaceutical Scientists (AAPS) |
AAPS 2009 National Biotechnology Conference
"Phase I INDs for Biologics: How Much Data is Adequate" |
Ron Marchesani
(speaker) |
Seattle, WA |
| Jun. 21-23, 2009 |
DIA |
45th DIA Annual Meeting |
Calley Herzog
Louise Johnson
David
Lin, Ph.D. Michael Salgaller, Ph.D.
Annie
Zurbay, RN, MSN, ND |
San Diego, CA |
| Jun. 11, 2009 |
ACRP Northern California Chapter |
“Emerging Markets: Clinical Trials in India” |
Louise Johnson (speaker) |
South San Francisco, CA |
| Jun. 10, 2009 |
BenAstrum |
“Comprehensive Forced Degradation Studies to Validate Stability-Indicating Methods for Biotechnology Products” |
Nadine
Ritter, Ph.D.(speaker) |
webinar |
| Jun. 8-11, 2009 |
Seton Hall Law School |
Health Care Compliance Certification Program
"Advertising & Promotion of Medical Devices" |
Stuart
Portnoy, MD
(speaker) |
Newark, NJ |
| June 2, 2009 |
BenAstrum |
Regulatory Expectations for Biologics Facilities: an ex-FDA Inspector's Outlook |
John
R. Godshalk, MSE, MBA
(trainer) |
webinar
Time: 1:00 PM EST |
| May 27-29, 2009 |
Cambridge Health Institute |
Biomarker World Congress 2009 |
Ron Salerno, PhD |
Philadelphia, PA |
| May 21-22, 2009 |
Prescription Pharma Support |
CMC Analytical, Comparability And Stability Studies For Biotechnology Products: Current Expectations, Practical Considerations
“Analytical and Stability Studies for Biotechnology Products” |
Nadine
Ritter, Ph.D.(speaker) |
Signapore |
| May 18-21, 2009 |
BIO |
BIO 2009 (booth #5232) |
Michael Salgaller, PhD
Jim Kenimer, PhD
Wilson
W. Bryan, MD
|
Atlanta, GA |
| May 18-19, 2009 |
Prescription Pharma Support |
CMC Analytical, Comparability And Stability Studies For Biotechnology Products: Current Expectations, Practical Considerations
“Analytical and Stability Studies for Biotechnology Products” |
Nadine
Ritter, Ph.D.(speaker) |
Bangalore, India |
| May 11-13, 2009 |
Pharmaceutical Education and Research Institute (PERI) |
Clinical Trial Planning and Management
"Trial Design for Efficient Drug Development " |
Wilson
W. Bryan, MD
(co-director) |
Arlington, VA |
| May 6, 2009 |
UMBC Graduate Program in Biotechnology |
"Laboratory Quality Practices: R&D, GLP and GMP” |
Nadine
Ritter, Ph.D.(speaker) |
Baltimore, MD |
| May 4-6, 2009 |
Society for Clinical Trials |
Annual Meeting |
Wilson
W. Bryan, MD |
Atlanta, Georgia |
| May 3-6, 2009 |
International Society for Cellular Therapy (ISCT) |
Annual Meeting
Pre-Conference Symposium: Translation of Stem Cell Therapies Symposium
"Product Development Challenges for Stem Cell Therapies"
"Quality and Manufacturing Considerations - From Concept to Pre-BLA"
Session: Balancing Regulatory Expectations and Industry Realities in Proof of Concept Studies and Preclinical Data
"Nonclinical Development of Cell Therapy Products – Reconciling FDA Expectations with Industry Realities" |
Darin
Weber, Ph.D. (speaker)
David
J. Pepperl, Ph.D. (speaker) |
San Diego, CA |
| Apr. 26 - May 1, 2009 |
American Academy of Neurology |
Annual Meeting |
Wilson
W. Bryan, MD
|
Seattle, WA |
| Apr. 25-29, 2009 |
CMC Strategy Forum Europe 2009 |
"CMC Perspectives on Biological Investigational Medicinal Products in Clinical Trials” |
Nadine
Ritter, Ph.D.(speaker)
Ruth Wolff, Ph.D. (speaker) |
Lisbon, Portugal |
| Apr. 16, 2009 |
BenAstrum |
Selection and Validation of Test Methods for Host Cell Proteins |
Nadine
Ritter, Ph.D.(speaker) |
webinar |
| Apr. 15, 2009 |
University of California, British Consulate-General, Canadian Consulate |
Stem Cell Research and Regenerative Medicine
The Promise of Stem Cell Research to Enable Regenerative Medicine |
Darin
Weber, Ph.D. |
San Francisco, CA |
| Apr. 9, 2009 |
North Carolina Biotechnology Center |
Combination Products Meeting |
Angela
Blackwell, MS
(panelist) |
Research Triangle Park, NC |
| Apr. 2, 2009 |
Regulatory Affairs Professional Society (RAPS) |
2009 RAPS Horizons Conference & Exhibition
"The Challenges of Nanotechnology:
Navigating the Field and the Regulatory Pathways" |
Stuart
Portnoy, MD
(speaker) |
San Francisco, CA |
| Mar. 31, 2009 |
Compliance Online |
Preparing for FDA Inspections |
John
R. Godshalk, MSE, MBA
(trainer) |
webinar
Time: 1:00 PM EST |
| Mar. 12, 2009 |
Compliance Online |
Facility Design Considerations |
John
R. Godshalk, MSE, MBA
(trainer) |
webinar
Time: 1:00 PM EST |
| Mar. 11, 2009 |
BenAstrum |
Preparing for FDA Inspections of Biologics and Biotech Facilities |
John
R. Godshalk, MSE, MBA
(trainer) |
webinar
Time: 1:20 PM EST |
| Mar. 9, 2009 |
Compliance Online |
Preparing for FDA Inspections of Devices and Combination Products |
John
R. Godshalk, MSE, MBA
(trainer) |
webinar
Time: 1:00 PM EST |
| Mar. 5-6, 2009 |
International Pharmaceutical Academy |
FDA Pre-Approval Inspections |
Nanda
Subbarao, Ph.D.
(speaker) |
Somerset, NJ |
| Mar. 2-3, 2009 |
World Research Group |
Cell Based Assays in Drug Development: Hands on Instruction on How to Stay Ahead of the Curve & Maximize Assay Quality while Minimizing Costs |
Nadine
Ritter, Ph.D.(speaker) |
Washington, DC |
| Mar. 2-3, 2009 |
IBC Life Sciences |
Process Validation for Biopharmaceuticals |
Ron Marchesani |
Carlsbad, CA |
| Feb. 25, 2009 |
BenAstrum |
Preparing for FDA Inspections of Biologics and Biotech Facilities |
John
R. Godshalk, MSE, MBA
(speaker) |
webinar |
| Feb. 18-20, 2009 |
Texas Scottish Rite Hospital for Children |
Carrell-Krusen Neuromuscular Symposium |
Wilson
W. Bryan, MD |
Dallas, Texas |
| Feb. 9-12, 2009 |
University of Texas |
International Conference on Drug Development
"Biomarker and Adverse Event Consortia Updates and Post Marketing Commitments" |
Ron Salerno, PhD
(moderator) |
Austin, TX |
| Feb. 3-4, 2009 |
DIA |
Regulatory and Scientific Issues that Challenge Comparability Assessment of Biopharmaceuticals |
John
Jessop, Ph.D., MPH |
Arlington, VA |
| Jan. 29, 2009 |
ComplianceOnline.com |
Webinar
"Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices" |
Stuart
Portnoy, MD
(speaker) |
webinar |
| Jan. 28, 2009 |
Vanderbilt University |
"The FDA Approval Process for Medical Devices" |
Angela
Blackwell, MS
(speaker) |
Nashville, TN |
| Jan. 26-27, 2009 |
Phacilitate |
Cell and Gene Therapy Forum 2009
"Designing cell and gene therapy clinical trials" |
Andra
Miller, Ph.D.
(session chair) |
Washington, DC |
| Jan. 19-20, 2009 |
BIO |
BIO Asia Partnering Conference 2009 |
T.W. Tanaka |
Tokyo, Japan |
| Jan. 12-14, 2009 |
CASSS |
WCBP 2009 |
Ron Marchesani |
San Francisco, CA |
Page
Updated:
January 3, 2012
|
|