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MICHAEL BLOH, B.Sc. Pharm, MBA Newtown Square, PA 19073 610-356-6596 (h) 610-368-6508 (m) mikebloh@yahoo.


SUMMARY Seasoned pharmaceutical professional with demonstrated leadership in pre- and post-market Pharmacovigilance, Drug Safety and Risk Management. A recoginized contributor to the safety community as trainer and communicator. Areas of IND and Post-licensure experience include: Development of Corporate Pharmacovigilance Policies, Risk Management, Quality Plans based on interpretation of regulations and guidelines. Influenced PV policy as chair of Drug Safety Development Steering Committee (DSDC). Cross divisional business processed facilitated by DSDC direction. Gap analysis and CAPA process lead for pharmacovigilance. Creation and implementation of PV SOPs for IND and licensed product complaint/safety process Implemented global interdepartmental SOP training and documentation. Budget, resource and project management based on multi-level workload analysis. Deliverables at or under budget, at or before deadline. Sucessful budget and resource negotiations with senior management and finance. Approaches PV as the insurer of revenue streams. Continuouse improvement cycle development via SOP, process and regulatory review. International PV team lead/contributor for legal, regulatory, quality initiatives. Chair of pharmacovigilance/investigation committees. PV representative during Health Authority inspections (FDA, EMEA, MHRA, etc.). Trains and presents on PV inspection preparedness. Facilitates employee development via periodic staff meetings. Provides valuable individual employee recognition. Develops win-win and works with employee relationships that strengthen teams. Minimizes silage and encourages cross team relationships to increase efficiencies. EDUCATION M.B.A. Management, Drexel University, Phila., PA, B.Sc. Pharm. - Philadelphia College of Pharmacy and Science, Phila., PA AWARDS DIA Outstanding Contributor to Clinical Safety and Pharmacovigilance Special Interest Community Aventis Pasteur Significant Contributor to Pharmacovigilance Systems Implementation

Areas of experience include: Ophthalmology, oncology, infectious diseases, vaccines, biologics, respiratory and gastro-intestinal products. Areas of IND and Post-licensure safety expertise include: Interpretation of US and International regulations and guidelines Creation and chair of Drug Safety Development Steering Committee Performed Quality Assurance audits of Safety process with appropriate CAPAs Creation and implementation of SOPs for IND and licensed product complaint/safety process Development of Corporate Safety Policies, Risk Management and Safety Monitoring Plans Creation of IND and licensed product Pharmacovigilance Plans including active follow-up Evaluation of pre-clinical safety data Authored Investigator Brochure AE sections, modernize Informed Consent Forms for risk management Creation of safety related case report forms and SAE reports, update CRFs for risk management Safety system updates and workflow modifications for risk management Trained Investigators, site and sponsor staff in pharmacovigilance and drug safety Review and summary of Clinical Research safety data Data assembly and presentation to DSMBs, DSMCs Developed and chaired Pharmacovigilance review committee Review and summary reporting of spontaneous AE collections as well as exterior safety data (VAERS, AERS) Implementation of EBGMPS methods of signal detection (denominator less methodology) Contributed to licensed product insert revisions and Medical-Legal reviews of sales materials. Author of US ASRs, Periodic Reports and PSURS Management/evaluation of safety department and personnel supervision Management of non-profit groups of up to 90 people Communication and issue resolution with International Regulatory/Health authorities Participated in product withdraw teams, Drug Safety contributor. Epidemiologic analysis of AE data downloads in MS Execll Sorts by gender, age, location, lot, HLT, etc. Author and contributor to AEs of Interest based on AE analysis findings. CLINICAL RESEARCH Organized and followed Phase I, II and III Clinical Trials internationally. SAFETY SYSTEMS MS Access based safety system creation, validation, implementation ARGUS, AERS ARISg , creation, implementation, validation of International database deployment Eudravigilance web based database system training INDUSTRY EXPERIENCE Consulting/Contracting April 2007 to Dec 2011

Subject Matter Expert (SME), ARIS Global, Stamford, CT Provide drug safety, pharmacovigilance and risk management expertise in developing and deploying the ARISg suite of products. (e.g. ag Composer, PBRER development) Pharmacovigilance Expert, Novartis, East Hanover, NJ Temporary contract (for sick leave), preparation of PSURs license applications, etc. for licensed and investigational products. SIGNAL DETECTION SPECIALIST, Merck (Schering-Plough), Springfield, NJ Consult with Executive Director on interpretation of safety related regulations or guidance. Signal detection of adverse events, rare adverse events, increased frequency, literature reports for licensed and investigational products PSUR, ASR, QSR, mentor, author and collaborator Risk Management Plan Training Risk Map/REMS Public Health Initiative Subutex/Suboxone Finland & ROW Q-Scan evaluation for drug signaling with FDA AERS and SP AE systems Adoption of standard references for product class evaluations Evaluation/update of SP Special Medical Event Terminology with EMEA Important Medical Events

Modernization of reporting of medical/medication errors and MedDRA terminolgy Modernization of reporting IND SAEs with analysis of similar events SP Position Paper Baseline Emergent Adverse Events for Investigational Products SP Position Paper Buprenorphine Labeling Amendment, Netherlands FDA Information Request Response Integrilin (eptifibatide) increased bleeding and death in dialysis patients FDA Information Request Response Integrilin (eptifibatide) acute profound throbocytopenia Millennium Pharmaceuticals Inc., Boston, MA Review/revision of pharmacovigilance policies and procedures following health authority inspection CAPA process for SOP revisions. Revision of investigator initiated clinical trials policies, reducing workload by 90%. Provided a risk based method of evaluating adverse events relavent to cancer chemotherapy Genaera Corporation, Plymouth Meeting, PA Pharmacovigilance consultant following company restructuring Sciformix, Mumbai, India Business development and selectition of first MSO Corus Healthcare, Upper Darby, PA Regulatory compliance for an infusion pharmacy (e.g. USP 797), SOP development ASSISTANT DIRECTOR, Genaera Corporation, Plymouth Meeting, PA Global Pharmacovigilance and Drug Safety End responsibility for Global Pharmacovigilance and Drug Safety Expansion of Pharmacovigilance department Project manager, ARISg implementation and validation Budget and resource planning ICSR and aggregate reporting Chair DSDC and pharmacovigilance committees. MANAGER, Aventis Pasteur US, Swiftwater, PA Special Projects, Global Pharmacovigilance Develop strategic safety concepts for safety and risk management Budget and resource planning, global department expansion. Pharmacovigilance Scientist/Regulatory Affairs Develop signal detection methods and strategies Manager, Pharmacovigilance Licensed and Investigational Products Oversee IND and LP AE process and report creation Product Safety Coordinator (supervisor level) Oversee the spontaneous AE reporting, create US PRs and Intl. PSURs Product Safety Associate Modernize spontaneous AE process and regulatory report creation Oct 2005 to Apr 2007

Oct 1996 Mar 2003

SENIOR CLINICAL RESEARCH ASSOCATE, William H. Rorer, Inc., Fort Washington, PA International clinical research for respiratory and GI products

Jun 1985-Jul1986

CLINICAL INVESTIGATOR AND PHARMACIST, Childrens Hospital of Philadelphia, PA Jul1980-May1985 Department of Infectious Diseases Performed investigational pharmacokinetic studies with hospitalized pediatric subjects Established HPLC Laboratory for determinations of antibiotic serum/urine levels in pediatric population OTHER PROFESSIONAL EXPERIENCE Chester Avenue Pharmacy, Inc., CEO, Philadelphia, PA Community pharmacist/pharmacy manager

PRESENTATIONS Nanomedicine, New Frontiers and Challenges to Pharmacovigilance IQPC Pharmacovigilance North America Introduction to Adverse Event Reporting Computerized Advers Event Reporting Design Health Network Communications, World Drug Safety Congress Americas Pharmacovigilance Inspection Preparedness Workshop Health Network Communications, World Drug Safety Congress Americas, ExL Pharma, FDAAA and Risk Management, FDAAA Essentials of Creation, Organizer, Chairperson, Discussion Moderator and Presenter



2009 2008

DIA Adverse Drug Events in Pre-marketing Clinical Trials and Post-marketing Pharmacovigilance, The Compliance, Medical Assessment and Risk Management Continuum. Program committee, Day 1 morning session chair, Regulatory Authorities Day1, History Structure and Function of the FDA 2008 Day 2, Before You Say, Eureka!, Individual to Aggregate Case Analysis Oncology Evaluation of Risks and Adverse Events: In Standard Operating Procedures for Investigational and Licensed Product Adverse Events, In Informed Consent Forms, In Adverse Event System Development, Evaluation of Adverse Event Risks vs. Unavoidable Side Effects in Oncology DIA Adverse Drug Events in Pre-marketing Clinical Trials and Post-marketing Pharmacovigilance, The Compliance, Medical Assessment and Risk Management Continuum. Program committee, Day 1 morning session chair. Day 1 - History, Structure and Function of the FDA Day 2 - Medication Error, a New International Risk, and Product Labeling FDAnews.com, Introduction to Eudravigilance and the EVWEB AE database system. CTFA, Impact of Adverse Event Reporting on the Cosmetic, OTC Drug and Nutritional Industry Discuss the impact of new federal legislation on these industries for reporting of serious adverse Events. DIA USA Annual Meeting Session Co-Chair Selection, Implementation, and Validation of a Vendor Safety Database System DIA EMEA Volume 9a Webinar Group leader for Section 10 FDAnews.com, Updating Company Core Data Sheets, An Airtight Processes SAE Report Training, Genaera Investigator Meetings Origins of Drug Safety/Drug Safety Orientation Genaera Pharmacovigilance Training Presentations Japanese Encephalitis Vaccine Adverse Events International Travel Medicine Association Annual Meeting, Venice, Italy 2008


2007 2007



2007 2005, 2006

2005, 2006, 2007


MedDRA, a New Terminology for Clinical Research and Pharmacovigilance Aventis Pasteur USA


PUBLICATONS Video Documentary: The Great American Fraud: The Golden Age of Patent Medicines With Public Television WHYY, Philadelphia, PA Chapter: Introduction to Nanotechnology Drug Discovery and Evaluation: Safety and Pharmacokinetics Assays, 2nd Ed. H. Gerhard Vogel. Franz Jakob Hock, Jochen Maas, Dieter Mayer, editors Springer Nanotechnology and Nanomaterials: New Frontiers in Drug Safety, Pharmacovigilance and Risk Management. A.M. Bloh DIA Global Forum Risk Based Assessment of Adverse Events vs. Unavoidable Side Effects in Oncology Millenium Seniour Management Report, A.M. Bloh Safety Corner - Newsletter articles for GC CROs and Contractors A. M. Bloh Vaccine Safety in the 21st Century, A Risk Management Approach, A. M. Bloh, Aventis Pasteur Senior Management Report Immediate Hypersensitivity Reactions After Use of Tuberculin Skin Testing, J. Froeschle, F. Ruben, A.M. Bloh Clinical Infectious Disease 2002:34 (1-January), e12-13 To Enable the FDA To Have Meaningful Inspections, A.M. Bloh, Aventis Pasteur Safety-Quality Management Report ARISg Training Program for US System Users, 1998-2002 A.M. Bloh Aventis Pasteur Pharmacovigilance Training Imipenem/Cilastatin Effectiveness in Treating Serious Infections in Hospitalized Children, G. Alpert, R. Degan, E. Connor, J.M. Campos, A.M. Bloh, S.A. Plotkin and K. Powell Am. J. Dis. Child., 139:1153 Determinations of N-formimidoyl Thienamycin in Pediatric Serum by HPLC, A.M. Bloh, J.M. Campos, G. Alpert and S.A. Plotkin, J. Chromatog. (Biomed. Appl.) 375:444-450 1985

(In preparation 2012)

(Accepted,Jan 2012)

Oct 2011 2008

2005, 2006, 2007





TRAINING AND DEVELOPMENT DIA-FDA REMS Template training webinar 2009 Schering Plough Mandatory PV/QA training Millennium Pharmaceutical Mandatory PV/QA training (~20 topics) 2008 Contemporary Pharmacovigilance and Risk Management Strategies - DIA, 2001, 2002. 2003, 2006, 2007, 2008 DIA Annual Meeting, 2006, 2007, 2008 Towards Better PSURs, A Masterclass, DIA 2007,2008 Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art, DIA 2007, 2008 CHI Drug Safety Strategies Approaches and Processes to Reduce Risk, 2006 Eudravigilance - Qualification and Training, DIA 2006 Electronic Submissions Update DIA, 2006 Elemental Epidemiology - DIA, 2006 Risk Management Comes of Age - DIA, 2002 PhARMA Annual Safety and Regulatory Quarterly Meetings 2001, 2002 Annual VAERS (CBER/CDC) Manufacturer's Meeting 1997, 1998, 1999, 2000, 2002

ARISg User Conference 1998, 1999, 2000, 2001 ARISg CIG Meetings 1998, 1999, 2000, 2001 MedDRA: A Practical Approach to Implementation - DIA, 2000, 2001, DIA Update 2006 Drug Safety and Surveillance - IIR, 2001 Active Leadership - Gilmore at AvP US, 2000 FDA Science 2000 Meeting - AE Signal Detection, AE Tracking/Trending - FDA, 2000 FDA Inspection Preparedness Training Workshop - Quintiles, 1999 Product Labeling: From Investigator Brochure to Core Data Sheet - PERI, 1999 Serious Adverse Experience Reporting for Investigational Products - AvP US, 1999 Good Clinical Practices - AvP US, 1999 MedDRA and Electronic Submissions - PERI, 1998 Company Core Data Sheets and Compliance with Future FDA Initiatives - PERI, 1998 Adverse Event Reporting and the Challenges of the Future - PERI, 1998 MedDRA - PERI, 1997 Good Clinical Practices Training Course - PERI, 1997 Adverse Events '97 - Barnett, 1997 FDA Update Meeting - ICH Guidelines and Compliance, Electronic Submissions - FDA, 1997 ASSOCIATIONS AND AFFILIATIONS Drug Information Association, International Society of Pharmacovigilance, International Society of Pharmacoepidemiology, PhARMA Regulatory and Clinical Safety Committee INDUSTRY ACCOMPLISHMENTS AND CONTRIBUTIONS DIA 2010, Clinical Safety and Pharmacovigilance Working Party Leader, Nanotechnology DIA 2007-10 Clinical Safety and Pharmacovigilance Core Committee member and Communication Coordinator DIA 2007 Annual Meeting Track co-chair and presenter Safety Database Systems. DIA 2007, 2008 Program Development committee Adverse Event Basic Training MedScape 2007 Non-traditional Pharmacists Positions with Jacqueline Kostic, PhARMA comments on Draft Guidance for Adverse Event Reporting for Licensed Products Aventis comments on Draft Guidance for Adverse Event Reporting for Licensed Products Revision of FDA VAERS-2 form Authored MedDRA v9.0 revisions added 60 new LLT or PT level terms for infusion related reactions, 2005-6 CBER policy change to monthly collection of non-serious AE reports for vaccines/biologics Collaborated with CDC in the investigation of Yellow Fever Viscerotropic Disease 1998-2001 Beta tester ARGUS, Oracle AERS, ARISg.


PERSONAL INTERESTS Skiing, biking, photography, music, Community Theater. VOLUNTEER INTERESTS Girls grade 2-3, 4-5 basketball coach Christmas in April/Rebuilding Together, Monroe County, PA Board of Directors, Players Club of Swarthmore AMB/5-12 2005-2007 1997-2002 1992-1995