Day 1 - Thursday, June 25, 2020

Registration and Continental Breakfast
Co-Chairs’ Remarks
The EMA and Related European Regulatory Bodies: Exploring Their Unique Roles, Interplay, and Significance to the Global Pharmaceutical Industry

  • The EMA: origins, creation and purpose vis-à-vis the principles and structure of the EU
    • Harmonization
  • Understanding how the EMA fits into the legal and regulatory structure of the European Union
  • Analyzing the EMA’s structure, organization and authority
    • Supra-national agency as opposed national agency
    • Defining EMA: a decentralized scientific agency
    • The EMA’s organization – Secretariat (management board); scientific committees; and scientific working parties
    • Exploring the seven scientific Committees and their roles/responsibilities
      • – Committee for Medicinal Products for Human Use (CHMP)
      • – Committee for Medicinal Products for Veterinary Use (CVMP)
      • – Committee for Orphan Medicinal Products (COMP)
      • – Committee on Herbal Medicinal Products (HMPC)
      • – Pediatric Committee (PDCO)
      • – Committee for Advanced Therapies (CAT)
      • – Pharmacovigilance Risk Assessment Committee (PRAC)
    • Regulatory authority as opposed to enforcement
    • Authority over medicinal products as opposed to devices
  • Identifying and analyzing significant regulations, directives and decisions affecting the EMA
  • Understanding the EMA’s role vis-à-vis other pharmaceutical regulatory bodies in Europe
  • Review of powers and authorities each member state retains aside from EMA’s centralized authority
    • Member state enforcement powers
    • Overview of key European pharmaceutical regulatory agencies
      • – MHRA (UK)
      • – BfArM/PEI (Paul-Ehrlich-Institut) (Germany)
      • – Affsapps (France)
      • – Sweden (MPA)
      • – Ireland (IMB)
      • – Swissmedic (Switzerland)
  • The Heads of Medicines Agency: purpose, scope and function
  • 9:15
    Examining the Status of “Brexit” and its Effects on Life Sciences Regulations Throughout Europe

    It appears imminent that Great Britain, once the home of the EMA will leave or exit the European Union. This event–while still pending–will have a huge and game changing impact on the life sciences industry. This session will explore measures already put in place and well as those anticipated to prepare for the effects of Brexit.

    • Examining changes which the European Medicines Agency (EMA) will put into effect to account for Great Britain’s departure
    • Exploring guidelines Great Britain will put into effect to regulate the life sciences industry
    • Analyzing policies life sciences companies must implement to comply with the impact of Brexit

    Morning Coffee Break
    The Nature of the Drug Approval Process in Europe via Centralized Procedure and Other Methods

  • Exploring the modes of obtaining marketing authorization (MA) in the EU/EEA
    • Centralized procedure
    • Mutual recognition aka MRP
    • Decentralized procedure aka DCP
    • National procedure
  • Evaluating the pros and cons of each of these methods
    • Examining the approval process in non- EEA European countries, e.g., Switzerland
  • Understanding the mechanics of the centralized procedure through EMA
    • Scope: mandatory (specific biotechnology drugs, ATMPs, NCE’s for specific conditions, orphan drugs) or optional (NCE’s for other conditions, innovations)
    • Assessment process by the EMA
    • MA decision making process by the each
      • Role of the individual Member States, comitology
    • Comparing the EMA centralized procedure with that the FDA approval process
  • Licensure: once approval and marketing authorization are granted, what authority do member states retain with respect to manufacture and distribution?
    • Role of Directive 2001/83 in maintaining control of full drug supply chain
  • 11:30
    Understanding EU Clinical Trials and Procedures

    EU Clinical Trials Directive

    • Overview of the EU Clinical Trial Directive
    • Understanding EMA’s role and responsibilities in the implementation of the Clinical Trials Directive as compared to that of the member states
    • Fine tuning the mechanics of the EU Clinical Trials Directive when conducting trials in member states
    • Exploring ethical concerns regarding placebo use under the Directive and as they apply to:
      • Non-inferiority studies
      • Comparator trials
      • Metabolic differentials
      • Conformed consent dilemmas
    • Understanding the role of key national ethical committees in the various member states
    • Identifying special requirements relative to pediatric trials in the EU
    • Examining the requirements of and relative to the EU clinical trial Database registry, i.e., EudraCT

    General Data Protection Regulation (GDPR)

    • Understanding the protections afforded to clinical trial subjects under the GDPR

    International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines for Good Clinical Practice (GCP)

    • Overview of ICH Guidelines for Good Clinical Practice
    • Understanding the significance of the ICH GPC Guidelines and how they tie into the EU Clinical Trial Directive

    EU Good Clinical Practice (GCP) Directive

    • Overview of the EU GPC directive and its requirements
      • Design; Record
      • Report
      • Inspection
      • Exports
    • Understanding the link between the GPC and Clinical Trials Directives and how they tie-in to the process for Centralized Procedure?

    Networking Luncheon
    Demystifying the Patent/Regulatory Interface in the EU: Generic Approvals, Exclusivities and More

  • Exploring procedures for the regulatory approval of generic medicinal products in the European
    • Definition of a generic medicinal product
    • Concept of the European reference product
  • Regulatory Data Protection (RDP) as distinct from patent protection
    • Analysis of the relevant provisions
    • Dual regime – the ‘old law’ and the ‘new’: 8+2(+1) formula
  • Is there any additional period of RDP?
    • New indication for a ‘well-established’ substance
    • Can generic applications be made based on Well Established Medicinal Use (WEMU)?
    • Switch in legal status (from prescription only to non-prescription – ‘OTC’
  • Concept of the Global Marketing Authorization
  • Examining the scope of the EU “Bolar” – type provision
  • Examining Supplementary Protection Certificates – an extension of patent life in the EU
  • The Paediatric Medicines Regulation
    • Scope and key obligations
    • What kind of reward/exclusivity are available (SPC extension/patent protected products, orphan drugs, off-patent products)?
  • The Orphan Drugs Regulation – obtaining orphan market exclusivity
  • 2:30
    Afternoon Coffee Break
    Biosimilars: A Study of Follow-On Biologics in the EU

    • Exploring the EU’s stance on follow-on biologics aka biosimilars
    • Understanding the EMA’s role in establishing the reference criteria for technical dossiers related to applications for authorization of biosimilars in the EU
      • The EMA’s definition of a biologic and a biosimilar
    • A look at the EU approval process for biosimilars through the centralized procedure
      • How does the approval of a biosimilar compare to that of a small molecule generic drug?
    • The significance of the Biosimilar Medicinal Products Working Party (BMWP)
      • BMWP’s role vis-à-vis CHMP’s role in the approval and regulation of biosimilars in the EU

    cGMPs in the EU

    • Defining cGMPs and the global scope of their importance
    • Examining the EU’s GMP Directive
      • Understanding EMA’s role in the GMP process
    • Identifying similarities between the EU’s GMP requirements and procedures and those established by the FD&CA in the U.S.
    • Assessing the pilot program for joint EMA/FDA inspections
    • Understanding EMA’s role in GMP inspections
      • How are international inspections coordinated?
      • How does EMA’s reach in GMP inspection compare with the FDA’s international reach in these matters?
    • Qualified Person aka QP: definition, function, necessity
      • Understanding the QP’s role in the GMP and inspection process
    • Examining the role of GMPs in EU import / export of drug products
      • Reimportation, repackaging, parallel trade

    Adverse Events Monitoring, Pharmacovigilance Protocols, and Recalls in the EU

    Adverse Events/ Pharmacovigilance


    • Overview of adverse events reporting requirements and protocols under the EU Clinical Trials Directive
    • Identifying the roles of EMA,PRAC, and CHMP in monitoring adverse events during the clinical phase
    • Understanding how adverse events databases like EudraVigilance are used during the clinical process
    • Use of adverse events reports in patient leaflets and product labeling


    • Overview of EU pharmacovigilance system
    • Analyzing EMA’s role in pharmacovigilance coordination in the EU
    • EU Risk Management Plan (EU-RMP)
      • Examining the EU’s use of Risk Management Plans
      • When is a risk management plan required?
      • How do RMPs compare to REMS in the U.S.?
    • Article 29/Article 31: understanding when there is opportunity to correct an adverse finding and when there is not
    • Understanding how the EudraVigilance database is used during the post-clinical or post-authorization stage
    • The use of QPs in pharmacovigilance reporting
    • Incorporating adverse events information at the post clinical stage in patient leaflets and product labeling
    • Exploring joint FDA/EMA safety efforts


    • What is EMA’s recall and oversight authority?
    • How does EMA’s recall authority coincide with that of EU member state regulatory bodies?
    • When should a drug be recalled in the EU?
    • Exploring the concept of voluntary recalls in the EU
    • Understanding how recalls fit into the EU’s pharmacovigilance system?
    • Examining EMA’s rapid alert notification system

    Boot Camp on European Pharmaceutical Regulatory Law Concludes