Curriculum Vitae

PERSONAL

Business Address: Robert C. Nelson Associates, Inc.

36 East Lake Drive, Suite 200

Annapolis, Maryland 21403 USA

Business Phone: (410) 263-3355

FAX: (410) 263-3932

E-mail: rcnelson@rcnrx.com

Website: www.rcnrx.com

EDUCATION

Dec 1992 Certificate - Federal Executive Institute (FEI) Leadership in a Democratic Society Program

May 1989 Certificate - Harvard University, School of Public Health Program for Advanced Training in Biomedical Research Management.

9/81 – 8/86 Doctor of Philosophy (Ph.D.) - University of Minnesota, Kellogg Pharmaceutical Clinical Scientist Program; Concentration in Epidemiology

9/76 – 4/79 Master of Science in Administration of Science and Technology (M.S.A.) - George Washington University, School of Government and Business Administration.

9/75 – 7/76 Foundation for Advanced Education in the Sciences Graduate Program, National Institutes of Health.

1/71 – 6/74 Bachelor of Science in Pharmacy (Pharm. B.S.) - Brooklyn College of Pharmacy, Long Island University.

9/68 – 1/71 Mechanical Engineering Major - City College of New York, City University of New York.

3/98 – Present : Independent consultant on drug safety to the pharmaceutical industry and related businesses. Areas of competency include: drug safety, clinical trial design, drug abuse liability assessments and drug scheduling, regulatory affairs, pharmacovigilance, risk management, pharmacoepidemiology, strategic planning, program development, post marketing surveillance process re-engineering, IT/IM systems development and forensic epidemiology. Operate as the principle for Robert C. Nelson Associates, Inc., a Maryland Corporation, dba RCN Associates.

7/75 – 2/98: Commissioned Officer in the U.S. Public Health Service. Retired with Military rank of Captain – 06.

9/95 – 2/98: Served as Associate Director (Epidemiology), Office Epidemiology & Biostatistics, Center for Drug Evaluation and Research (CDER,FDA). Charged with re-engineering the FDA's Post Marketing Drug Safety Surveillance Program for human drugs and therapeutic biologics. Responsible for strategic planning and formulating policy for epidemiology. Responsible for coordinating, then implementing the International Conferences on Harmonization (ICH) initiatives (M1, M2, E2A, E2B, E2C) related to post marketing surveillance (PMS); the comprehensive PMS regulations rewrite and subsequent guidance development, and managing the development and implementation of the Adverse Event Reporting System (AERS), a global drug safety network.

To these ends I managed up to 18 advisory work groups and multimillion dollar contract to a major consulting firm, Booz Allen & Hamilton.

9/89 – 8/95: Director, Office of Professional Development and Staff College. I assumed responsibility for the establishment and implementation of a comprehensive program for orientation, training, continuing education, advanced education and associated fellowship programs within CDER. Directed the Center's regulatory research program and professional support efforts. Responsible for forging relationships with major university-based graduate programs and for negotiating an environment for academic cross-fertilization. Supervised and directed staff of 27 full-time and 200 part-time faculty of the Staff College.

10/87 – 9/89: Assistant Director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, FDA, a unit with a staff of 135 persons. Assumed responsibility to identify, resolve, and/or maintain surveillance of the critical Issues and/or problem areas concerning the regulation of anti-infective, anti-viral, metabolic, dermatological, ophthalmic and hormonal drug products. Evaluated action items involving over-the-counter (OTC) products and petitions for abbreviated NDAs. Functions as a resident expert on study design and analysis, including those used in epidemiology. Served as director for program management for ODE II and the CDER AIDS Coordination efforts.

7/88 – 7/89: Acting Deputy Director, Office of Professional Development and Staff College (OPD/SC). This was a part-time special assignment.

2/87 – 9/87: Assistant Director, Office of Biologics Research and Review, Center for Drugs and Biologics, FDA, a unit with a staff of 450 persons. Assumed responsibility to identify, resolve, and/or maintain surveillance of the critical issues and/or problem areas concerning the regulation of a broad range of drug products, and biological products, and made scientific recommendations to the Office Director. Functioned as a resident expert in study design and analysis, especially those used in epidemiology. Provided coordination on inter-divisional and inter-office scientific issues.

1/85 – 3/88: Project Officer, Cooperative Agreement FD‑U‑000078‑01, Mayo Clinic, Prenatal Drug Effect on Pregnancy Outcome.

10/86 – 1/87: Detailed to the Office of Biologics Research and Review, FDA. Served as Special Assistant to the Director. Duties were as assigned.

5/85 – 9/86: Epidemiology Team Leader, Office of Epidemiology and Biostatistics, FDA. Was responsible for coordinating all the post‑marketing surveillance efforts of the Office for neurological, psycho-pharmacological and analgesic drugs. Supervised the work assignments and served as scientific leader for a safety review team consisting of eight health professionals, (physicians, epidemiologists, pharmacists and statisticians). Collaborated with the Directors of the New Drug Approval Divisions on issues of post-marketing drug safety.

7/84 – 4/86: Deputy Chief, Adverse Reaction and Poisoning Surveillance Branch, Office of Epidemiology and Biostatistics, FDA, a unit composed of 10 professionals and 14 support personnel. Duties and functions of the Branch include the continued development, maintenance and design of output from the Agency's adverse drug reaction, adverse biologics reaction and poisoning case report databases. These databases serve as the cornerstone of the Agency's postmarketing surveillance efforts.

11/83 – 6/84: Chief, Poisoning Surveillance and Epidemiology Branch, Office of Epidemiology and Biostatistics, FDA, a unit composed of four professional and four support personnel. Duties and functions of the Branch include the collection, tabulation and analysis of case reports from poison control centers nationwide; surveillance of trends in mortality; epidemiological studies on consequences of non‑medical drug use; and served as the designated Federal link to the poison control professional community.

10/82 – 10/83: Visiting Health Scientist in Epidemiology, Mayo Clinic, Rochester, Minnesota. Mentor: Leonard T. Kurland, M.D.,Dr.P.H.

8/80 – 11/83: Special Assistant to the Chief, Drug Abuse Staff, Division of Neuropharmacological Drug Products, FDA. Duties included coordination of the Drug Abuse Staff activities with other involved components of FDA, as well as all other involved governmental organizations towards the formulation abuse potential evaluations and recommendations to control centrally active drugs under domestic law (CSA) and international obligation (Single and Psychotropic Conventions). Served as the Executive Secretary to FDA's Drug Abuse Advisory Committee.

10/77 – 8/80: Pharmacy Consultant and Staff Assistant to the Director, Division of Neuropharmacological Drug Products, Office of New Drug Evaluation, FDA. Duties and responsibilities included serving as Executive Secretary to the Psychopharmacologic Drugs Advisory Committee, Peripheral and CNS Drugs Advisory Committee and the Drug Abuse Advisory Committee. Served as an administrative liaison between the Group Leaders of the functional scientific units and the Division Director for special projects.

7/75 – 10/77: Commissioned Officer in the USPHS stationed at the Clinical Center, Pharmacy Department, National Institutes of Health, Bethesda, MD. Served as clinical pharmacy liaison to the intramural program of the NINCDS, its health care personnel and its patients.

7/74 – 6/75: Resident in Clinical Pharmacy in an ASHP accredited program at the University of Connecticut Health Center, Farmington, CT. Mentor: Paul G. Pierpaoli, M.Sc.Pharm.

Software Designed

QED Solutions Inc.’s QScan^TM^,a pharmacovigilance and drug safety analyses toolset (1999-2001) - in part

Relsys International Inc.’s ARGUS-PV^TM, a comprehensive pharmacovigilance system for the pharmaceutical industry (2001 – 2004)

NLabel Inc.’s NLabel Manager a content development and exchange product for product labels and related regulatory documents, for the pharmaceutical industry (2001 – 2005).

NLabel Inc.’s eDrugLabel^TM , a content development and exchange MSP for product labels and related regulatory documents, for the pharmaceutical industry (2001 – 2005).

NLabel Inc.’s eXchanger, a B2B portal for exchange of regulatory materials at the document, component, content or data levels.

Nlabel Inc's PSUR Assembler Portal, to manage and control the development and assembly of E2C compliant Periodic Safety Update Reports via document component management.(2003 - 2005)

AWARDS AND HONORS

Jun 1974 Joseph L. Mayer Award for excellence in Quantitative and Instrumental Analytical Chemistry, received at graduation from Brooklyn College of Pharmacy, Long Island University.

Jun 1975 Commissioned to the Reserve Corps of the United States Public Health Service by the Surgeon General of the United States.

Jun 1979 USPHS Commendation Medal "In recognition of outstanding scientific and administrative abilities as Pharmacy Consultant and Executive Secretary to the Division of Neuropharmacological Drug Products," Bureau of Drugs, FDA.

Sep 1981 Awarded the designation of Doctor of Pharmacy (P.D.) by Maryland State Department of Health.

1981 – 1983 USPHS Fellowship in Epidemiology sponsored by the Food and Drug Administration.

1981 – 1984 Fellowship, Kellogg Foundation, Pharmaceutical Clinical Scientist Program, University of Minnesota.

Jul 1982 Commissioned to the Regular Corps of the United States Public Health Service by the President of the United States, by and with the consent of the U.S. Senate.

Feb 1985 USPHS Citation, "For outstanding evaluation of the Agency's Poison Control Program while serving as its Chief, and for recommending changes which should achieve greater efficiency.

Jun 1986 USPHS Unit Commendation, "For commendable achievement in adverse drug reaction surveillance and analysis which facilitated technical improvements in managing scientific and medical considerations in drug therapy.

Sep 1987 USPHS Achievement Medal, "For ingenuity and dedication in the application of scientific and administrative skills to Office of Biologics Research and Review functioning during a highly visible time frame."

Jan 1988 USPHS Unit Commendation, "For outstanding efforts in facilitating the implementation of Title 1 of the 1984 Waxman-Hatch amendments to the FD&C Act as they pertain to citizen's petitions to submit ANDA's for altered drug products."

Apr 1988 USPHS Unit Commendation, "For dedicated efforts in serving on FDA's Commissioned Corps Revitalization Committee."

Jun 1989 USPHS Outstanding Service Medal "For Innovative Scientific and Administrative Leadership Fostering FDA's Active Role in Evaluating AIDS Drugs."

May 1990 USPHS Unit Commendation, "For exceptional achievement in the development of the programs and activities of the Staff College, and the enrichment of CDER's professional and scientific environment"

Jan 1991 Awarded an Exceptional Capability Promotion to Captain - 06 by the USPHS Surgeon General

Aug 1992 Awarded the Designation of Associate of the Staff College by the Director, Center for Drug Evaluation and Research, FDA

May 1995 USPHS Unit Commendation “ For developing a new reviewer training program in the Center for Drug Evaluation and Research”

Feb 1998 FDA Commissioner’s Special Citation “For outstanding leadership and exemplary project management in the design, development and implementation of the Adverse Event Reporting System for CDER & CBER”

Feb 1998 Harvey W. Wiley Medal for 20 years of service at the Food and Drug Administration (upon retirement).

Member, Subcommittee of Psychoactive Drug Hazards, Medical Care Section, American Public Health Association (1982‑1987).

Research Associate, Dept. of Medical Statistics and Epidemiology, Mayo Clinic (1982‑1987).

Member, Task Force on Pharmacoepidemiology, Medical Care and Epidemiology Sections, American Public Health Association (1986‑1987)

Member, Task Force on Benzodiazepine Dependency, American Psychiatric Association (1986‑1989).

Member, Organizational and Planning Committee for the 4th International Conference on Pharmacoepidemiology (1987‑1988).

Panel Moderator, AIDS Drugs, 4th International Conference on Pharmacoepidemiology (Sep 1988).

Board Member, International Society for Pharmacoepidemiology (ISPE), (1991-1995).

Member, Substance Abuse Committee, American Society for Clinical Pharmacology and Therapeutics (ASCPT), (1991-1993).

Member, Task Force on Career Pathways for Clinical Research, National Academy of Sciences' Institute of Medicine (NAS/IOM), (1991-1993).

Member, Policy and Education Committees, International Society for Pharmacoepidemiology (ISPE), (1991-1994).

Member, Educational Steering Committee, Society of Regulatory Affairs Professionals (RAPS, 1993-present).

Panel Moderator, Pharmacoepidemiological Research & Public Health Policy, 9th International Conference on Pharmacoepidemiology (August, 1993).

Member, Royal Society of Pharmaceutical Medicine’s Signal Generation & Evaluation Committee (5/96 – 6/99)

Chairman, International Society for Pharmacoepidemiology (ISPE) Ad Hoc Committee On Drug Risk Assessment, 1998-2000

Panel Chair & Speaker, Data Quality for Drug Risk Assessment Symposium, 15th Annual ICPE September 29, 1999

Panel Moderator and Speaker, Drug Information Association Annual Meeting, Denver 2001

Eisler, T., Nelson, R.C., Calne, D.: Deprenyl in Parkinsons Disease, Neurology 3l:19‑23, Jan. 1981.

Nelson, R.C.: delta‑9 THC Distribution, Amer. Jour. Hosp. Pharm 38:29, Jan. 1981 (Letter).

Rector, T., Nelson, R.C.: The Clinical Scientist Concept Drug Intell, & Clin. Pharm. l6:882‑3, Nov. 1982 (Letter).

Rector, T, Nelson, R.C.: Clinical Scientist or Pharmacy Administrator? Author's Reply, Drug Intell. & Clin. Pharm. 17:377i, April 1983 (Letter).

Tocus, E., Nelson, R.C., Vocci, F.: Benzodiazepines: Regulatory Perspectives, Jour. of Psychoactive Drugs 15(l‑2): l5l‑l57, Jan.‑June 1983.

Nelson, R.C., et al: Poisoning Among Young Children ‑ United States, MMWR, 33(10): 129‑131, 1984.

Brancato, D.J., Nelson, R.C.: Poisoning Mortality in the United States, 1980, Vet. Hum. Toxicol. 26(3), June 1984.

Nelson, R.C.: Comment on Poison Prevention, Drug Intell. Clin. Pharm. 17:377i, April 1983 (Letter).

Nelson, R.C., Kurland, L.T., Beard, C.M.: SIDS: Is It Increasing? J.A.M.A. 253(17) :2494 May 1985 (Letter).

Nelson, R.C.: A Call For Pharmacoepidemiologists, Amer. Journ.Hosp. Pharm. 42:2145 Oct. 1985 (Letter).

Nelson, R.C.: Comment on Addiction Liability of Benzodiazepines and Buspirone, Drug Intell. & Clin. Pharm. 20:233‑4 March 1986 (Letter).

Baum, C., Hsu, J.P., Nelson, R.C.: The Impact of the Addition of Naloxone on the Use and Abuse of Pentazocine. Public Health Reports. 102(4): 426‑429, 1987.

Ressigue, L., Noller, K., Nelson, R.C.: Pitocin and SIDS, New England Journal of Medicine. 315(3):193 July 1986 (Letter)

Nelson, R.C.: Psychotherapeutic Drugs, Psychiatric Morbidity and Automobile Crashes: A Case‑Control Study of 1,308 Females. Doctoral Thesis, Univ. of Minnesota, Sept. 1986.

Nelson, R.C., Rector, T., Beard, M., Kurland, L.T.: Psychotherapeutic Drugs, Mental Disorders and Automobile Crashes: A Case‑Control Study of 1,308 Females. In: Noordzij, P.C., Roszbach, R. eds. Alcohol, Drugs and Traffic Safety ‑ T86. Proceedings of the 10th International Conference on Alcohol, Drugs and Traffic Safety, Amsterdam, 9‑12 September 1986. Amsterdam:Elsevier Science Publishers. pp. 275‑278, 1987.

Esber, E.C., Nelson, R.C., Broader, N.J.: The Safety Assessment of Antiviral Drugs. Proceedings, NATO Advanced Study Institute on Antiviral Drug Development. Il Ciocco Italy, May 20, 1988, pp.261-273.

Nelson, R.C.: Risk Assessment of New Drugs, Pharmacoepidemiology and Regulatory Decision Making. Proceeding of the 3rd International Conference on Pharmacoepidemiology, Sept. 1987, Lewis Publ., 1989, pp. 23-41 (Chapter 2).

Nelson, R.C., et al: The Epidemiology of Sudden Infant Death Syndrome in Olmsted County, MN., Submitted to Mayo Clinic Proceedings.

Nelson, R.C.: Drug Safety, Pharmacoepidemiology and Regulatory Decision Making. Drug Intell. and Clin. Pharm. 1988; 22:336-44, and reprinted in: Hartzema, A.G. ed. An Introduction to Pharmacoepidemiology. Harvey Whitney Books, 1988.

Salzman, Carl., et.al., Benzodiazepine dependence, toxicity, and abuse. A Task Force Report of the American Psychiatric Association, APA Publications, 1990.

Nelson R.C, Peck C.C.: Clinical Pharmacology Training at the Food and Drug Administration. Journal of Clinical Pharmacology, 32:400-406, 1992.

Nelson, R.C.: Drug Safety, Pharmacoepidemiology and Regulatory Decision making. in An Introduction to Pharmacoepidemiology, 2nd Edition, Hartzema, A.G.ed., Whitney Books, 1991 (Chapter 15).

Lieberman, R., Nelson, R.C.: Dose Response and Concentration-Response Relationships: Clinical and Regulatory Perspectives. Therapeutic Drug Monitoring, 15:498-502, 1993

Ahmad, S.R., et. al.: Analysis and Comparison of Adverse Drug Experience Reporting by Different Reporters to the FDA. Pharmacoepidemiology and Drug Safety, 1994

Nelson, R.C., Pederson, D., D’Souza,T.: U.S. FDA AERS Project. Book chapter in Electronic Communication Technologies, Mervyn Mitchard, ed., InterPharm Press, 1998

Nelson, R.C.: Drug Safety, Pharmacoepidemiology and Regulatory Decision making. Book Chapter in An Introduction to Pharmacoepidemiology, Third Edition, Hartzema, A.G.ed., Whitney Books, 1998.

Nelson, R: We need a Postmarketing Drug Development Process!, A Commentary. Pharmacoepidemiology and Drug Safety 9:253-255(2000)

Bright, R., Nelson R.C. : Automated Support for Pharmacovigilance: A Proposed System. Pharmacoepidemiology and Drug Safety 2002;11:121-125

Nelson, R.C., Palsulich, B., Gogolak, V., Good Pharmacovigilance Practices - Technology Enabled. Drug Safety 2002; 25 (6): 407-414

ABSTRACTS

Nelson, R.C.: Progressive Management of Progressive Hospital Pharmacists, USPHS Professional Association, Mar l978.

Scigliano, J., Nelson, R.C.: Clinical Research with Schedule I Substances: The Role of the FDA. USPHS Professional Association, Apr 1979.

Scigliano, J., Nelson, R.C.: Therapeutic Potentials of Marijuana, USPHS Professional Association, Apr 1979.

Scigliano, J., Nelson, R.C.: Impediments to the R&D of Marijuana/THC Dosage Formulations, USPHS Professional Association, Apr 1979.

Scigliano, J., Nelson, R.C.: PHS Involvement in New Therapies for Pain and Discomfort ‑ an Interagency Committee, USPHS Professional Association, Apr 1979.

Nelson, R.C.: International Convention on Psychotropic Substances: Ramifications on the Pharmaceutical Industry and on Pharmacy Practice, American Pharmaceutical and Association, Apr 1982.

Nelson, R.C.: Assessing the Abuse Liability of the Benzodiazepines, Association of Military Surgeons, Oct. 1982

Tocus, E., Nelson, R.C., Vocci, F.: Benzodiazepines: Regulatory Perspectives, Benzodiazepines Today: A National Conference, Oct 1982.

Nelson, R.C., et al: The Epidemiology of Sudden Infant Death Syndrome in Olmsted County, MN, USPHS Professional Association, Jun 1984.

Nelson, R.C., Baum, C.: Maprotiline and Seizures: An Analysis of FDA's Adverse Reaction System, American Public Health Association, Nov 1985.

Nelson, R.C., Barash, D., Graham, D.: Intense Abstinence Syndromes Associated with the Newer Benzodiazepine Anxiolytics, USPHS Professional Association, Jun 1986

Baum, C., Hsu, J.P., Nelson, R.C.: The Impact of the Addition of Naloxone on the Use and Abuse of Pentazocine, USPHS Professional Association, Jun 1986.

Vocci, F., Nelson, R.C.: Benzodiazepines: Detection, Phenomenoly, and Treatment of the Withdrawal Syndrome American Society of Hospital Pharmacists, Dec 1986.

Nelson, R.C.: Psychotherapeutic Drugs, Psychiatric Morbidity and Automobile Crashes. USPHS Professional Association, Nov.1987.

Nelson, R.C.: Phase IV as Part of New Drug Development, Drug Information Association, Jun 1989.

Nelson, R.C., Peck C.C.: Clinical Pharmacology Training at the FDA. American Society of Clinical Pharmacology and Therapeutics, Mar 1991.

Ahmad, S.R., et. al.: Analysis and Comparison of Adverse Drug Experience Reporting by Different Reporters to the FDA. Poster presented at the 10th International Conference on Pharmacoepidemiology, Stockholm, Sweden. Aug 1994

Bright, R., et.al., Automated Safety Signal Detection at FDA’s Center for Drug Evaluation and Research. 13th International Conference on Pharmacoepidemiology, Montreal. Aug 1997

Nelson, R.C.: Accutane and Major Depression – The Importance of Epidemiology in Pharmacovigilance. ISPE Poster, Toronto 2001

Nelson, R.C.: Risk Management at the US-FDA and on the analyses of spontaneous reports. 7^th Annual Conference of the Japanese Society of Pharmacoepidemiology, Tokyo 2001

TECHNICAL REPORTS

Nelson, R.C., Vocci, F., Batz, R.: Ketamine HCl; An Abuse Liability Assessment. Prepared for and presented to FDA Drug Abuse Advisory Committee, Feb 1979.

Kartzinel, R., et al: Response to the Health Research Groups' Imminent Hazard Petition for Darvon^R, FDA, HHS, Jun 1979.

Nelson, R.C., Vocci, F., Tocus, E.: Evaluation of the Current CSA Control Status Three Anorectics, Phentimetrazene, Phentermine, and Diethylproprion as Prompted By a Petition to FDA From the Drug Enforcement Administration. Prepared for and presented to FDA Drug Abuse Advisory Committee, Nov 1980.

Gorodetzky, C.W., Nelson, R.C. et al: Final Report, Subcommittee on Effects of Scheduling Under the Federal Controlled Substances Act. FDA Drug Abuse Advisory Committee, Apr 24, 1980.

Nelson, R.C., Tocus, E.C., Vocci, F.: The Benzodiazepines, Dept. Health and Human Services Report to the World Health Organization, Jul 1981.

Nelson, R.C.,: Electronic Submission of Adverse Reaction Data to the FDA’s Adverse Events Reporting System (AERS), Mar 1997

Nelson, R.C., Strategic Plan for Post Marketing Surveillance for Human Drugs at FDA, Feb 1998

Note: Technical reports prepared for clients of the drug safety-consulting firm, RCN Associates, are not publicly disclosable by this consultant.

Nelson, R.C., Burke, L.B.: Pharmacists and the FDA: Interaction Pathways and Information Sources. An FDA Exhibit Booth utilized at the ASHP Midyear Clinical Meeting Dec 1979, and the APHA Annual Meeting Apr 1980

Nelson, R.C.: The Abuse Liability Evaluation of Drugs‑Scientific and Legal Aspects, Pharmacists of FDA Professional Association, Jun 1981.

Nelson, R.C.: The FDA New Drug Approval Process, Graduate Seminar, College of Pharmacy, University of Minnesota, Jan 1982.

Nelson, R.C.: Psychotherapeutic Drugs, Psychiatric Morbidity and Automobile Crashes: A Case Control Study of 1308 Females. Ph.D. Thesis

Jun 1983 University of Minnesota, Graduate Departments of Epidemiology and Social and Administrative Pharmacy.

Aug 1984 Food and Drug Administration, Office of Epidemiology and Biostatistics Seminar.

Nelson, R.C.: Assessing a Drug's Abuse Liability, Premarketing and Post‑Marketing, Seminar, Kellogg Pharmaceutical Clinical Scientist Program, University of Minnesota, Jun 1983.

Faich, G.A., Nelson, R.C.: The Federal Poison Control Program 1984, Briefing to Acting Commissioner Novitch, Apr 1984.

Nelson, R.C.: Amoxapine Toxicity, seminar, Food and Drug Administration, Office of Epidemiology and Biostatistics, Oct 1984.

Nelson, R.C.: Self‑Poisoning in Adults, presentation to the National Poison Prevention Week Council, Dec 1984.

Nelson, R.C., Faich, G.A.: Bioequivalence of the Thioridazine Generics; Postmarketing Issues, seminar, Food and Drug Administration, Division of Epidemiology and Surveillance, Nov 1985.

Nelson, R.C., Baum, C.: Unique Uses of Adverse Event Data, Seminar, Food and Drug Administration, Office of Epidemiology and Biostatistics, Feb 1986.

Nelson, R.C.: Interpretation of the D.A.W.N. Signal forAlprazolam. Federal Interagency Committee for Drug Control I.C.D.C.), Jun 1986.

Nelson, R.C.: The Application and Utilization of Postmarketing Epidemiologic Findings by FDA, American Public Health Assoc. Research Forum of Pharmacoepidemiology, Sep 1986.

Nelson, R.C.: FDA CDER's Need for Natural History Data for use as Historical Control Cohorts in Investigations with AIDS-Drugs, USPHS AIDS Task Force's Subcommittee on Epidemiology, Mar 1988.

Nelson, R.C.: Zidovudine (AZT) One Year Later - Report on the Phase IV Monitoring Activities, FDA’s Anti-Infectives Advisory Committee, May 1988

Nelson, R.C.: FDA's AIDS-Drug Research and Review Effort, Symposium on Pharmacotherapy for the AIDS Patient, Sep 1988.

Nelson, R.C.: The Development and Review of AZT, Staff College Fellows Forum, Jun 1989.

Nelson, R.C.: Pharmacists as Principal Investigators - FDA's Position, Case Reserve University, Sep 1989.

Nelson, R.C.: Accutane: Regulatory Perspective of FDA, 5th International Conf. on Pharmacoepidemiology, Sep 1989.

Nelson, R.C.: Pharmacists as Principal Investigators- FDA's Position, American Society of Hospital Pharmacists Mid-Year Clinical Meeting, Dec 1989.

Nelson, R.C., Accutane: Background, Status and Regulatory Concerns, Joint Session of the Dermatology and the Fertility & Maternal Health Advisory Committees, May 1990.

Nelson, R.C., Graham, D.: Accutane - An Update, 6th International Conference on Pharmacoepidemiology, Aug, 1990

Nelson, R.C.: Postapproval Regulatory Activities, CDER Staff College Regulatory Science Course, Mar 1991, Oct 1991, and May 1992, Jun 1994, Nov 1994, Nov 1995.

Nelson, R.C.: Pentazocine Regulatory Case Study, CDER Staff College Regulatory Science Course, Oct 1991.

Nelson, R.C.: Zidovudine (AZT) Regulatory Case Study, CDER Staff College Regulatory Science Course, Oct 1991.

Nelson, R.C.: Regulatory Use of Pharmacoepidemiological Data, 8th International Conference of Pharmacoepidemiology, Sep 1992.

Nelson, R.C.: Regulatory Issues in Clinical Trials, ASHP Clinical Meeting, Dec 1995

Calvert, W, Nelson, R.C., et.al.: FDA/CDER Initiatives in Electronic ADR Submissions, DIA Workshop, Dec 1995

§ World Health Organization’s National Centres for Drug Safety Meeting: Lisbon, Portugal, Sep 1996

§ Center for Professional Development Course in ADR Reporting: New Brunswick, NJ. Feb 1997

§ World Health Organization Conference in IT and Regulatory Affairs: Uppsula, Sweden, Apr, 1997

Nelson, R.C.: Fen-Phen, DexPhen! Whose Debacle is it ? (Ramblings of an Ex-Regulator), 14th ISPE , Berlin, August , 1998

Nelson, R.C.: Global Implementation of the ICH-PMS Initiatives, IBC Conference, Pharmacovigilance ’98, August 1998

Nelson, R.C.: Global Implementation of the ICH PMS Initiatives, Barnett ADR Conference, Philadelphia, September 1998

Nelson, R.C.: FDA Regulation and Guidelines on Drug Safety -Spontaneous Reporting and Beyond !, Barnett Drug Safety Conference, Boston, October 1998

Nelson, R.C.: US-FDA’s Initiatives in Global Drug Safety, CBI Conference, Washington, D.C., March 1999

Nelson, R.C.: Drug Safety and Public Health, American College of Preventative Medicine, Washington DC, March,1999

Nelson, R.C.: The Computer Working for Us & Not Us for the Computer, DIA Annual Meeting, June 1998

Nelson, R.C.: International Society for Pharmacoepidemiology (ISPE) Ad Hoc Committee On Drug Risk Assessment, 15th Annual ICPE Data Quality for Drug Risk Assessment Symposium, September, 1999

Nelson, R.C.: Global Implementation of the ICH PMS Initiatives, Barnett ADR Conference, Philadelphia, September 1999

Nelson, R.C.: FDA Regulations and Guidelines on Drug Safety, , Barnett ADR Conference, Philadelphia, September 1999

Nelson, R.C.: Current FDA Perspectives on Post-Marketing Surveillance. CBI 2nd Annual Conference. Philadelphia, April, 2000

Nelson, R.C. Understanding the Relationships between PSURs, FDA's Risk Management Strategy, CIOMS V, "Duty to Warn" and Beyond, DIA Annual ADR Conference, Washington D.C., Jan.2001

Nelson, R.C. Good Pharmacovigilance Processes & Practices, DIA Annual ADR Conference, Washington D.C., Jan.2001

Nelson, R.C.: Technology Supported Good Pharmacovigilance Practices (GPVP). Drug Safety Research Unit Conference of Signaling, Southampton UK June 2001

Nelson, R.C.: Risk Management and Good Postmarketing Surveillance Practices. DIA Annual Meeting, Denver, July 2001

Nelson, R.C.: Accutane-Psychiatric Disorder Issue Work-up, A Pharmacoepidemiological Safety Assessment, Univ. of Maryland Graduate Seminar, Baltimore, May 2001

Nelson, R.C.: Risk Management at the US-FDA and on the analyses of spontaneous reports. 7^th Annual Conference of the Japanese Society of Pharmacoepidemiology, Tokyo November 2001

Nelson, R.C.: Risk Communication via Good Document Management of Product Labels, Drug Information Association (DIA) Strategic Document Management Conference, Philadelphia, PA, February 14, 2002

Nelson, R.C.: Can Safety Sell? Drug Information Association (DIA) Annual Meting, Chicago, IL. June 2002

Nelson, R.C.: Risk Communication via Good Document Management of Product Labels, Drug Information Association (DIA) Annual Meting, Chicago, IL. June 2002

§ Member, Task Force for the Development of Clinical Guidelines for the Use of Endogenous Peptides and their Analogues (9/79 to 7/80).

§ Participant and Executive Secretary for the FDA Drug Abuse Advisory Committee's Ad Hoc Subcommittee to Study the "Effects of Scheduling" (9/78 to 4/80).

§ Member, Project Advisory Panel for the "Evaluation of Hospital Abstracting Services as a

§ Member, Review Panel on the Issues Underlying the Criteria for the Scheduling of Propoxyphene under the CSA (7/79 to 12/79).

§ Member, Division of Neuropharmacologic Drug Product's Hypnotic Drug Task Force (4/78 to 11/78).

§ Program Co‑Chairman, FDA's Pharmacists' Professional Association (l/80 to 9/81).

§ Invited Participant, White House Conference of Prescription Drug Misuse, Abuse, and Diversion. Nov. 23‑25, 1980.

J. 5/91 to 8/91

§ Preceptor, Tulane University's Master of Public Health extern training program (1/79 to 5/79).

§ Preceptor, University of Maryland's pharmacy extern training program (l0/79 to 2/81).

§ FDA Representative to the National Poison Prevention Week Council (11/83 to 3/85).

§ Ex‑officio Member, American Association for Poison Control Centers, Data Collection Committee (3/84 to 3/85).

§ Center for Drug Evaluation and Research Representative (CDER), FDA‑Commissioned Corps Revitalization Group (4/87 to 4/90)

§ Center for Drug Evaluation and Research Representative, FDA Sabbatical Program Task Force (8/87 to 6/89).

§ Chairman, CDER's Commissioned Corps Advisory Committee (CCAC) (6/88 to 4/90).

§ Chairman, FDA's Zidovudine (Retrovir^R) Monitoring Group (ZMG) (3/87 to 6/90).

§ Member, Project Advisory Group (FDU-0000 71-0-7-1) Boston Collaborative Drug Study Program - H. Jick, Principal Investigator. (10/88 - 6/91).

§ Member, Project Advisory Group (FDU-0000-82-07) Slone Epidemiology Unit, Boston University - S. Shapiro, Principal Investigator. (10/88 - 6/91).

§ Chairman, Adverse Event Reporting System (AERS) Overall Project Advisory Group. (9/95 – 2/98).

§ Member, Good Pharmacovigilance Practices AERS Project Advisory Group (9/95 – 2/98)