Hyman Phelps and McNamara Hyman Phelps and McNamara
Conferences
UPCOMING CONFERENCES
May, 2013
  Compliance Online Webinar: Auditing Systems for 21 CFR Part 11 Compliance - Preparing Yourself for Inspection  May 21, 2013
  DIA Webinar: Biomarker Strategies for More Efficient Early-Phase Drug Development in Alzheimer's Disease  May 21, 2013
  Respiratory Drug Delivery Conference  May 21 - 24, 2013
  ACI: Health Care Privacy and Security Forum  May 22 - 23, 2013
  USDA Food Safety & Inspection Services (FSIS) & FDA Interagency Risk Assessment: Listeria monocytogenes in Retail Delicatessens - Public Hearing  May 22, 2013
  Compliance Online Webinar: FDA Warning Letter Closeout Program  May 29, 2013
June, 2013
  ACI: Summit on Advertising Privacy Compliance - Mobile Apps, Smart Phones & the World Wide Web  June 3 - 5, 2013
  HealthTech: Clinical Trial Oversight Summit  June 3 - 6, 2013
  RAPS Executive Development  June 3 - 6, 2013
  CBI: Medical Device and Diagnostics Compliance Congress  June 4 - 5, 2013
  World Pharma Congress - Advancing Preclinical Predictions, Faster Clinical Decisions  June 4 - 6, 2013
  NY State Bar Association: The HIPAA Omnibus Rule - Best Practices for Compliance  June 5, 2013
  ACI: Advanced Forum on Biosimilars  June 6 - 7, 2013
  Thompson Interactive Webinar: Privacy and Consent in Research - Impact of HIPAA/HITECH Omnibus Final Rule  June 6, 2013
  Quintiles Webinar: Accelerating Drug Development by Harnessing Technology  June 7, 2013
  ASRC: Summit on Private Environmental Governance: Facing the Challenges of Voluntary Standards, Supply Chains and Green Marketing  June 10, 2013
  CBI/IVT's 2nd Bio/Pharmaceutical and Medical Device Product Recalls Summit  June 11 - 12, 2013
  MD&M East:MedTech Conference & Exhibition  June 17 - 20, 2013
  RAPS Webinar: Understanding the Regulatory Landscape for Adaptive Design Trials  June 18, 2013
  DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Sciences  June 23 - 27, 2013
  C5 Online: Maximising Pharma Patents  June 25 - 26, 2013
  ACI: Off-Label Communications  June 26 - 27, 2013
  ACI: The Legal, Regulatory and Compliance Forum on Dietary Supplements  June 26 - 27, 2013
July, 2013
  ACI: Advanced Regulatory and Compliance Summit on Food & Beverage Marketing & Advertising  July 17 - 18, 2013
  CBI: 6th Annual Congress on Access Programs for Investigational and Pre-Launch Drugs  July 17 - 18, 2013
  CBI: Orphan Drug Innovation Summit 2013  July 17 - 18, 2013
September, 2013
  ACI: FDA Boot Camp  September 17 - 18, 2013
  The International Congress on PIV Litigation  September 23 - 24, 2013
  Federal Bar Association Annual Meeting and Convention  September 26 - 28, 2013
  RAPS: The Regulatory Convergence  September 28 - October 2, 2013
October, 2013
  FDLI International Conference: China-US Updates in Food and Drug Law  October 15 - 16, 2013
  AIPLA Annual Meeting  October 24 - 26, 2013
 
PAST CONFERENCES
May, 2013
  ABA Webinar: The Ethics of Legal Marketing in a Social Media Age  May 16, 2013
  ABA: Health Care Fraud 2013  May 15 - 17, 2013
  ACI: Global Export Controls Compliance  May 15 - 16, 2013
  IBC: Human Factors for Drug-Device Combination Products  May 14 - 15, 2013
  Mentorhealth webinar: Anti-Kickback Statute and Stark II: Basis for An Action Under the Federal False Claims Act? Your Organization May be at Risk  May 14, 2013
  RAPS: eCTD Submissions for ANDAs, 505(b)(2)s, DMFs and ASMFs  May 14 - 15, 2013
  FxTrans Promotion Webinar  May 9, 2013
  ACI: Managed Care Disputes & Litigation  May 8 - 10, 2013
  DC Bar: Fundamentals of Federal Administrative Law Practice Series Part II - Judicial Review of Agency Decision Making  May 8, 2013
  Global Compliance Panel Webinar: CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations  May 8, 2013
  Thompson Interactive Webinar: The New Medical Device Excise Tax - What Companies Need To Know and Do  May 8, 2013
  ACI: Paragraph IV Disputes  May 7 - 8, 2013
  Council for Responsible Nutrition Hot Topics Webinar: Complex Structure Function Claims - A case study of inflammation claims  May 7, 2013
  Thompson Interactive Webinar: The New FDA Sunshine Act Final Rule - Navigating Corporate Responsibility  May 7, 2013
  Florida Medical Device Consortium (MMC): Medical Device Symposium  May 6 - 7, 2013
  DC Bar: Part 1 Only - Fundamentals of Administrative Law Practice Series - The Informal Rulemaking Process  May 2, 2013
  Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School: Food and Drug Administration in the 21st Century  May 2 - 4, 2013
  AIPLA Spring Meeting  May 1 - 3, 2013
April, 2013
  Food Safety Summit Expo and Conference  April 30 - May 2, 2013
  Xavier.edu: FDA National Forum  April 30, 2013
  Xavier.edu: MedCon 2013 Medical Device Conference  April 30 - May 1, 2013
  ACI: Legal and Business Guide to mHealth and Wireless Medical Technology  April 29 - May 1, 2013
  DIA Webinar: Preparing for the Physician Payment Sunshine Implementation - Research, Marketing & Education  April 29, 2013
  RAPS Webinar: Advertising, Promotion and Labeling - the US Regulated Environment  April 29, 2013
  PathWise: Audit Management  April 25 - 26, 2013
  AMBAR: Internal Corporate Investigations  April 24 - 26, 2013
  AMBAR: Section of Litigation Annual CLE Conference  April 24 - 26, 2013
  IP Counsel Cafe: Pressurized to Monetize Our IP - Are We All Becoming Patent Trolls?  April 24 - 26, 2013
  Thompson Interactive Webinar: There's an App for That - Regulating Mobile Medical Devices  April 24, 2013
  FDLI Annual Conference  April 23 - 24, 2013
  PathWise: CAPA for Life Sciences  April 23 - 24, 2013
  Food and Drug Law Institute Annual Conference  April 22 - 24, 2013
  Health Care Compliance Association: Compliance Institute  April 21 - 24, 2013
  CLE: Qui Tam False Claims Act - All Points of View  April 18 - 19, 2013
  Compliance Online: Why is FDA at my facility, and what do I do during an inspection?: 2-day In-person Seminar  April 18 - 19, 2013
  FDA HHS: Advisory Council Annual Spring Symposium  April 18 - 19, 2013
  ACI: Green Marketing Compliance Summit  April 17 - 18, 2013
  AMDM's 40th Annual Meeting & OIVD Submissions Workshop  April 17 - 20, 2013
  Compliance Online Webinar: 21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s  April 16, 2013
  IN³ Medical Device 360° Dublin  April 16 - 18, 2013
  Medical Affairs Strategic Summit  April 16 - 18, 2013
  Specialty Pharma Association Annual Conference  April 16 - 18, 2013
  DIA: CMC Workshop - From Drug Development to Global Supply to Patients  April 15 - 17, 2013
  Advanced Practice Under the America Invents Act  April 11 - 12, 2013
  BBB: Children's Advertising & Online Privacy Conference 2013  April 10, 2013
  Compliance Online Webinar: Auditing the QC Microbiology Laboratory for FDA Compliance  April 10, 2013
  Thompson Interactive Webinar: How to Avoid Noncompliance and Research Misconduct in Clinical Trials  April 9, 2013
  Advertising Claims Support: Case Histories and Principles  April 8 - 10, 2013
  ABA: 28th Annual Intellectual Property Law Conference  April 3 - 5, 2013
  ABA: Annual Administrative Law and Regulatory Practice Institute  April 3 - 4, 2013
  FDLI: Introduction to Drug Law and Regulation  April 3 - 4, 2013
  FDLI: Introduction to Medical Device Law & Regulations  April 3 - 4, 2013
  Federal Bar Association Webinar: Holy Tweet - How to Maximize a Company's Use of Social Media  April 2, 2013
March, 2013
  FDLI: Controlled Substances Regulation  March 28, 2013
  Federal Bar Association Webinar: Substance Abuse, Mental Health and Violence  March 27, 2013
  American University Washington College of Law: Health Law Symposium and Alumni Dinner  March 21, 2013
  Global Compliance Panel Webinar: Excel Spreadsheet Validation To Eliminate 483s  March 21, 2013
  ACI: Fraud and Abuse in the Sale and Marketing of Drugs  March 20 - 22, 2013
  MedMarc Webinar: Best Practices in dealing with FDA Inspections  March 20, 2013
  ACI: FDA Boot Camp  March 19 - 20, 2013
  ANA: Advertising Law & Public Policy Conference  March 19 - 20, 2013
  Crowel: Staying Afloat When Your Brand Is Under Pressure - How To Avoid, Mitigate, and Manage Product Crises  March 19, 2013
  DIA: Medical and Scientific Communications 2013 Forum  March 19 - 20, 2013
  University of Southern California Intellectual Property Institute  March 14, 2013
  C5 Online: 24th Biotech Patenting  March 13 - 14, 2013
  American Law Journal Television Program: "Off Label Drug Marketing and Free Speech"  March 11, 2013
  Biotherapeutics Analytical Summit  March 11 - 14, 2013
  CHPA Annual Executive Conference  March 11 - 13, 2013
  ALI-CLE Webinar: False Claims Act and Qui Tam Provisions - What's New?  March 7, 2013
  RAPS: Medical Device Submission & Compliance Strategies for the US Market Workshop  March 7 - 8, 2013
  ALI-CLE Webinar: I'll Consent to That: Drafting Effective Conflict Waivers  March 6, 2013
  ACI: Medical Device Patents  March 5 - 6, 2013
  DC Bar: What Every Lawyer Needs to Know About Customs and Customs Law 2013  March 5, 2013
  CBI: 8th Biosimilars Summit  March 5 - 6, 2013
  CBI: Global Clinical Sourcing and Supply Summit  March 4 - 5, 2013
  FDLI: Medical Device Compliance, Regulation and Litigation Conference  March 4, 2013
February, 2013
  FDA Food Safety Modernization Act: Public Meeting  February 28 - March 1, 2013
  RAPS: CGMPs for Combination Products - Final Rule and Implementation  February 28, 2013
  ACI: Life Sciences Collaborative Agreements and Acquisitions  February 27 - 28, 2013
  ACI: In-House Counsel and Pricing Executive Forum on Government Regulation of Prescription Drug Pricing  February 26 - 27, 2013
  Compliance Online Webinar: GLP and Compliance for a Clinical Laboratory's Incident Management Plan  February 26, 2013
  GMA Webinar: Food Contact Materials - A European Perspective  February 26, 2013
  ACI: ITC Litigation & Enforcement  February 25 - 26, 2013
  IBC Life Sciences: Biopharmaceutical Development & Production Week  February 25 - March 1, 2013
  ALI-CLE Webinar: Lawyer Blogs; Useful Tool? Ethical Minefield? Both?  February 21, 2013
  CHA Webinar: Genetically Engineered Animals as a Source of High-Affinity Human Antibodies  February 21, 2013
  DC Bar: Health Reform in the Current Political Climate  February 21, 2013
  ABA: Conference on Emerging Issues in Healthcare Law  February 20 - 24, 2013
  IFT: Establishing Food Allergen Thresholds  February 20, 2013
  DIA: Marketing Pharmaceuticals 2013 - Workshop for Regulatory, Legal, Communications Professionals, and Promotional Review Teams  February 19 - 21, 2013
  FOI Teleconference: The FDA Inspection is Over...What Do I Do Now?  February 19, 2013
  FOI Teleconference: FDA Likes Clinical Trial Enrichment - Should You Care?  February 14, 2013
  FDLI Webinar/Conference: Pharmacy Compounding - An FDLI Dialogue  February 12, 2013
  IFT Webinar: Produce Safety Standards FDA and Industry Expert Insights  February 11, 2013
  Molecular Med TRI-CON 2013  February 11 - 15, 2013
  Compliance Online: Why is FDA at my facility, and what do I do during an inspection?: 2-day In-person Seminar  February 7 - 8, 2013
  FOI Teleconference: Spreadsheet Validation - Ensuring Compliance with 21 CFR Part 11  February 7, 2013
  Compliance Online Webinar: CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment  February 6, 2013
  Drug Delivery Partnerships  February 6 - 8, 2013
  CBI: Effective Preparation for FDA Advisory Committee Meetings  February 5 - 6, 2013
  DC Bar: Part 4 of 4 Parts - Introduction to Health Law Series 2013: Compliance Issues and Privacy  February 5, 2013
  FDLI Annual Food Week Program  February 5 - 8, 2013
  Patient Recruitment and Retention in Studies and Registries  February 5 - 7, 2013
  EU and US Regulatory Issues for IP Professionals  February 4 - 5, 2013
  FDA Public Hearing: Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need  February 4 - 5, 2013
January, 2013
  Compliance Online Webinar: China - Compliance Processes for Life Science Products  January 31, 2013
  Compliance Online Webinar: CRO GCP Compliance Failure - What Are The Sponsors Options?  January 31, 2013
  FOI Teleconference: The Food and Drug Administration Safety and Innovation Act (FDASIA) - How Will YOU Be Impacted?  January 31, 2013
  HPM presents a webinar on Real-World Implications of United States v. Caronia  January 31, 2013
  American Intellectual Property Law Association - Mid-Winter Institute;  January 30 - February 2, 2013
  CBI: Forum on Oncology Commercialization Strategies  January 30 - 31, 2013
  BBB: Data Privacy & Protection Day Town Hall & Breakfast  January 29, 2013
  Compliance Online Webinar: Roles and Responsibilities of the Clinical Research Physician  January 29, 2013
  DC Bar: Part 3 of 4 Parts: Introduction to Health Law Series 2013: Introduction to Medicare  January 29, 2013
  ACI: European Pharmaceutical Regulatory Boot Camp  January 28 - 29, 2013
  Personalized Medicine World Conference (PMWC)  January 28 - 29, 2013
  Compliance Online Webinar: CDISC - FDA's Expectations, Requirements For US FDA Submissions, Concepts And Implementation; 2013 & Beyond  January 25, 2013
  Compliance Online Webinar: Informed Consent - A Process, Not a Piece of Paper  January 25, 2013
  ACI: Advertising, Promotions and Digital Marketing for the Life Sciences Industry  January 24 - 25, 2013
  FOI Teleconference: Patient Selection - FDA's New Guidance for Improving Clinical Trial Success  January 24, 2013
  New York State Bar Association - Annual Meeting of the Food, Drug and Cosmetic Law Section  January 24, 2013
  ABA: The 2013 E-Discovery and Information Governance National Institute  January 23 - 25, 2013
  ACI: The Comprehensive Guide to Patent Reform  January 23 - 24, 2013
  Compliance Online Webinar: Superiority, Non-inferiority, or Equivalence Trials - How, Why and When  January 23, 2013
  DIA Webinar: Off-label Marketing Regulation in the Wake of the U.S. v. Caronia decision  January 23, 2013
  Global IP Convention  January 23 - 30, 2013
  IFT Webinar: Preventive Controls for Human Food FDA and Industry Expert Insights  January 23, 2013
  Compliance Online Webinar: Implementing Performance Metrics for Clinical Research Associates (CRAs) and Data Targeted Monitoring  January 22, 2013
  DC Bar: Part 2 of 4 Parts: Introduction to Health Law Series 2013: Introduction to Medicaid  January 22, 2013
  Compliance Online Webinar: Clinical Trial Quality and Risk Management - A Detailed Guide To Be Compliant and Manage Risks  January 18, 2013
  Compliance Online Webinar: How to Avoid Protocol Deviations at Development and Execution Phase of a Global Clinical Trial  January 17, 2013
  FOI Teleconference: Bioresearch Monitoring (BiMo) for Sponsors & Clinical Investigators - FDA Requirements and a Case Study  January 17, 2013
  Compliance Online Webinar: Optimal Clinical Supply Planning for Global Drug Development  January 16, 2013
  Thompson Interactive Webinar: New NIH Conflict of Interest Rules and their Impact on Industry-Academia Relationships  January 16, 2013
  Compliance Online Webinar: Sponsor and Investigator Roles and Responsibilities in Clinical Research-Specificity and Cooperation are Equally Important  January 15, 2013
  DC Bar: Part 1 of 4 Parts: Introduction to Health Law Series 2013 - Introduction to the U.S. Health Care System  January 15, 2013
  Compliance Online Webinar: Pediatric Trials in Developing Countries - Ethical Requirements & Development of Guidelines  January 14, 2013
  DIA: Pharmacovigilance and Risk Management Strategies 2013  January 13 - 16, 2013
  Audioconference: When a 510(k) or PMA Goes Off Track - FDA's Appeals Process  January 10, 2013
  Compliance Online Webinar: Negotiating Clinical Trial Contracts in a Minefield - The Stark Rule, Anti-kickback Statute (AKS), ...  January 10, 2013
  FOI Teleconference: The Caronia Off-Label Promotion Decision - What Does It Mean for FDA-Regulated Firms?  January 10, 2013
  FOI Teleconference: Foreign Clinical Studies - Current FDA Regulations & Expectations  January 9, 2013
December, 2012
  Compliance Online Webinar: Modifications to a Cleared Device - FDA's 510(k) Guidance  December 20, 2012
  ALI-CLE: False Claims Act and Qui Tam Provisions - What's New in 2012 and Beyond?  December 18, 2012
  Thompson Interactive Webinar: Preparing for and Surviving Sponsor Audits and FDA Inspections  December 17, 2012
  Compliance Online Webinar: Computerized System Validation - A Detailed Insight  December 13, 2012
  Compliance Online Webinar: Reducing eDiscovery risk for Pharmaceutical Companies  December 13, 2012
  RAPS Webinar: Lifecycle Regulatory Compliance for Medical Devices  December 13, 2012
  Thompson Interactive Webinar: The Basics of Device Complaint Handling  December 13, 2012
  Compliance Online Webinar: Understanding the Scope of FDA's Inspection Authority and Its Ability to Access Company Records  December 12, 2012
  FDA Public Hearing: Antiseptic Patient Preoperative Skin Preparation Products  December 12 - 13, 2012
  FDLI: Enforcement, Litigation and Compliance Conference  December 12 - 13, 2012
  FOI Teleconference: FDA's IND Safety Reporting Requirements for Clinical Trials - What You Need to Know NOW  December 12, 2012
  RAPS: Regulatory Strategy Forum for Biologic Products  December 10 - 11, 2012
  Compliance Online Webinar: Quality Assurance at the (Clinical Research) Site - How to Develop a Manageable Plan  December 7, 2012
  ACI: Health Care Privacy and Security Forum  December 6 - 7, 2012
  Compliance Online Webinar: Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory  December 6, 2012
  DC Bar: Basics of Filing and Litigating Freedom of Information Act Requests 2012  December 6, 2012
  FOI Teleconference: FDA's Website & Beyond - Finding FDA Records to Meet Agency Expectations and Research Regulated Firms  December 6, 2012
  IFT's 2012 Food Policy Impact Conference  December 6, 2012
  Compliance Online Webinar: Preparing for FDA's Unique Device Identification Rule  December 5, 2012
  Compliance Online Webinar: Understanding Expanded Access for Medical Devices  December 5, 2012
  Global Compliance Seminar - FDA 510(k): Contents, Submission and Clearance  December 5, 2012
  CBI: IVT's 3rd Annual Stability Programs Forum  December 4 - 6, 2012
  Compliance Online Webinar: Medical Foods Understanding what Constitutes a Medical Food for FDA Regulatory Purposes  December 4, 2012
  Compliance Online Webinar: Personnel Practices and Microbial Control in Pharmaceutical, Biotech, and Medical Device Manufacturing  December 4, 2012
  Compliance Online Webinar: Social Media - Using The Legal Guideposts to Create Social Media Success (for Healthcare/Lifescience Companies)  December 4, 2012
  FDLI: Nanotechnology Law, Regulation and Policy Conference  December 4, 2012
  FOI Teleconference: Annual Reports - SOPs for Developing Content Which Meets FDA Requirements  December 4, 2012
  Food Chemical News: The Impact of FSMA on Food Importing Conference  December 4 - 5, 2012
  ACI: Drug and Medical Device Litigation  December 3 - 5, 2012
  ACI: Paragraph IV Disputes  December 3 - 5, 2012
  Risk Management and Drug Safety Summit  December 3 - 4, 2012
November, 2012
  ACI: Food Borne Illness Litigation  November 29, 2012
  EU and US Regulatory Issues for IP Professionals  November 29 - 30, 2012
  FDLI: Regenerative Medicine - Key Developments in Regulation & Commercialization  November 29, 2012
  FOI Teleconference: Dealing with "NO!" (or Endless Questions) from FDA  November 29, 2012
  ACI: Biotech Patents  November 28 - 29, 2012
  ACI: Food Consumer Fraud Litigation  November 28, 2012
  ACI: Orphan Drugs and Rare Diseases Conference  November 28 - 29, 2012
  ACI: U.S. Customs Compliance Boot Camp  November 27 - 28, 2012
  FOI Teleconference: FDA Device Program Staff Explain the Revised Refuse to Accept/File Guidance Documents  November 27, 2012
  RAPS Webcast: Lifecycle Regulatory Compliance for Medical Devices  November 27, 2012
  FOI Teleconference: Medical Devices in Canada - A Regulatory Roadmap to Approval & Compliance  November 26, 2012