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Chapmanpharmaceuticals.comChris Chapman, M.D.
Cell phone 301-793-3771 E-mail: [email protected] _______________________________________________________ Georgetown University School of Medicine 1987 Medical Doctor, MDGeorgetown University School of Medicine 1988 Internal Medicine Internship, CertificateGeorgetown University School of Medicine 1989 Anesthesiology Residency, CertificateGeorgetown University School of Medicine 1991 Cardiovascular, Obstetrics and Critical Care, Anesthesiology Fellowship 2009 – Present Executive Global Pharmacovigilance Management
Consultant to Takeda Pharmaceutical (NASDAQ: TKPHF) Consultant to Hi-Tech pharmaceutical (NASDAQ: HITK) Consultant to ECR Pharmaceutical (NASDAQ: HITK) Consultant to Church and Dwight Committee for MDR Review (NYSE: CDH) 2004 – Present
Manager of Chapman Pharmaceutical Consulting Inc., a Consulting Organization that provides support on Product Safety, Pharmacovigilance,Medical Devices, Clinical, and Regulatory issues for Pharmaceutical and Biotech Companies in North America, Europe, Japan, India and Africa. Works with Compliance Management Consulting's experienced team of former FDA officials led by Ed McDonnell, a principal in the preparation of FDA Medical Device Guidance including the Medical Device Good Manufacturing Practice (GMA) Regulation. Provides medical device reporting, and post-market requirements. Performed GMP and GLP regulatory device analysis for one year at a major lab. Completed regulatory GCP and GLP regulatory analysis of adverse events related to Insulin Pumps for Device Company.
Consultant Manager for MiddleBrook Pharmaceuticals product Keflex for Infectious Diseases. Responsible for managing the licensing agreement of Keflex from Eli Lilly to MiddleBrook. Manage worldwide IND Pharmacovigilance, Post Marketing AE’s and SAE’s that are entered into AERS database and coded in MedDRA.
Manager for staff at Enzon Pharmaceuticals products Ablecet for invasive fungal infections and Oncaspar for Leukemia. Manage worldwide drug safety and Pharmacovigilance for IND and spontaneous reports. Conduct quarterly epidemiologic, signaling and trending reports. Responsibilities include review of NDA Annual report for labeling changes, pediatric population, and distribution data for quanity and total dosage usage.
Board of Directors
Rock Creek Pharmaceuticals (NASDAQ: CIGX) Chris Chapman, M.D.
Cell phone 301-793-3771 E-mail: [email protected] _______________________________________________________ Star Scientific (NASDAQ: CIGX) (since 2005) Compensation Committee, Audit Committee, Nomination Committee Organon Pharmaceuticals Associate Director of Drug Safety, Pharmacovigilance, and Clinical Operations. Supervised four Medical Doctors, and ten Drug safety specialist. The products included Tice BCG for bladder cancer and Zemuron for Anesthesia. Products for contraception included Nuva Ring, Implanon, Cyclessa, and Desogen. Worked with the German office to review all US and International AE’s and SAE’s reports. Completed review of all Med Watch and CIOMS reports. Sign-off on events in an Organon specific adverse event database. Worked in clinical operations for FDA meetings, IND preparation and medical monitoring of clinical trials. Managed Class 1-111 devices for neuromuscular transmission, including 510(k), PMA, IDE, and GMP.
Founding Director of Quintiles Medical Affairs, Drug Safety and Medical Writing Departments. Grew Division from no employees to forty employees; including eight board certified physicians, four RNs, two pharmacist, eight medical writers and supporting staff. The Medical Affairs Department supported numerous studies, INDs, device submissions, and NDAs. Prepared study reports and the ISS and ISE for a drug which was approved by the FDA. Recruited the following Board Certified Physicians in Medical Affairs Department: Internal Medicine, Cardiology, Allergy/Immunology, Neurology, Oncology and Infectious Disease. Responsibilities included Pharmaceutical Development Safety and Pharmacovigilance. Provided advice and support for preparation of 510(k), IDE, PMA, and PDP. Including cardiovascular and wound devices.
1995 – 2006 Doctor¹s Community Hospital, Lanham, Maryland Attending Physician
Responsible for the management of quality care for more than four thousand critically ill patients over eleven years. Consulted with Neurologist, Internal Medicine, Cardiologist, Surgeons, Psychiatrist, G.I., Infectious Disease, Pulmonary, and Medical Oncologist, on the quality of patient care. Managed the resuscitation of over seventy patients in critical care medicine.
Chris Chapman, M.D.
Cell phone 301-793-3771 E-mail: [email protected] _______________________________________________________ 1992-1994 Regeneron Pharmaceuticals, Inc. Tarrytown, New York Medical Director
Managed clinical trial safety and efficacy of a Phase I/II study to determine the safety, tolerability, and pharmacokinetics of recombinant Human Ciliary Neurotrophic Factor (rHCNRF) in patients with ALS during both acute and subacute administration. Wrote the clinical report and submitted to the FDA. Presented findings of the Phase I/II safety data to the FDA resulting in immediate approval of the Phase III protocol. Designed and implemented quality assurance procedures for monitoring IND clinical trials. Designed and implemented procedures reporting all deaths, hospitalizations, or serious adverse events to IRBs. Visited all 36 sites pre-study, during the study, and post-study. Conducted investigator meetings pre-study and during the study. Responsibilities included licensing, early development and Pharmacovigilance.
1991 – 1992 Roberts Pharmaceutical Corporation, Eatontown, New Jersey Medical Director
Managed clinical trials safety and efficacy of Agrelin (Anagrelide), an anticancer drug for the control of excess platelet production in patients with Leukemia. Presented data to the FDA which resulted in an NDA submission and approval. Other products included Somagard (a study agent tested for use in the treatment of central precocious puberty, prostate cancer, and endometriosis); Maxivent Bronchodilator (a study agent tested for the use in the treatment of asthma). Managed all Phase IV studies and Post Marketing Adverse Events. Responsibilities included early development of Pharmaceutical safety and Pharmacovigilance.
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