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Non-Clinical Safety Sciences and Their Regulatory Aspects

Feb 24 2014 8:00AM - Feb 28 2014 1:30PM | Hotel Florida Rue Duque de Palmela, 34 1250-098 Lisbon Portugal

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Overview 

This course provides a full introduction to preclinical safety testing relating to regulations and guidelines in Europe (national, CHMP, ICH level). The course faculty is European-based leading experts in preclinical safety testing and safety sciences. Topics will be presented through interactive lecture and hands-on workshop training methods, with an emphasis on practical application of the regulations and guidelines pertinent to preclinical and clinical medicines development and registration. The content for this course focuses on development of small molecule medicines and biologically-derived medicines.

Continuing Education

The “Non-Clinical Safety Sciences and Their Regulatory Aspects” training course has been accredited with 5 ECTS credits by the University of Lisbon, Portugal. DIA meetings and training courses are generally approved by the Commission for Professional Development (CPD) of the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society of Pharmaceutical Medicine (SGPM) and will be honoured with credits for pharmaceutical medicine. All participants are eligible for these credits.

What You Will Learn 

  • Role of preclinical safety studies in medicines development and registration in Europe
  • Outline of preclinical medicines discovery and development, regulatory and industry perspectives
  • Translational aspects of preclinical safety sciences, including safety biomarkers
  • Scope and type of preclinical safety studies and timing to clinical development and registration
  • Contemporary scientific and regulatory topics of interest: environmental risk assessment, single and repeat dose toxicity, establishing first human dose, juvenile animals studies, safety pharmacology, toxicity to the immune system, genotoxicity carcinogenicity testing, pharmaco-toxicokinetics, metabolism, reproduction toxicology protocols and interpretation for pregnancy labelling of pharmaceuticals, when mechanistic studies are needed, impurities and others
  • Specific aspects of, e.g., vaccines, anticancer medicines, biotechnology-derived medicines
  • The Common Technical Document and Assessment Report structures in Europe may be included on case-by-case basis

Who Should Attend 

Professionals in preclinical research and development, project management, regulatory affairs, medical writing, clinicians for Phase 1, and pharmacovigilance. The course is valuable for professionals in regulatory agencies outside Europe. Participants should preferably have a previous fair understanding of aspects of medicines development and registration.

Learning Objectives 

At the conclusion of this course, participants should be able to:

  • Discuss the scope and needs for preclinical safety programmes in relation to clinical trials in Europe
  • Discuss calculations of First-In-Human doses
  • Identify requirements for successful preclinical medicines development in Europe
  • Describe European culture and complexity in the registration system
  • Explain the fundamentals of preclinical medicines development in Europe, and in ICH environment
  • Share recent real world experiences of preclinical medicines development agencies and companies in Europe

Hotel & Travel 

DIA has blocked a limited number of rooms at the following hotel:

Hotel Florida
Rua Duque de Palmela, 34
1250-098 Lisbon
Portugal

Tel.: +351 21 357 61 45
Fax: +351 21 314 13 47
Website: www.hotel-florida.pt

at the rate of:
EUR 80.00 per single room inclusive of American Buffet Breakfast, WIFI, all taxes and services.

To make your reservation, please use this booking form.

Important: The room rate is available until 30 January 2014 or until the group block is sold-out, whichever comes first.

Contact Information 

DIA Europe
Kuechengasse 16
4051 BASEL
SWITZERLAND

TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: diaeurope@diaeurope.org

Faculty 

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Agenda  

Day 1 Monday, Feb 24, 2014

  • 8:00AM - 8:30AM

    REGISTRATION
  • 8:30AM - 8:45AM

    COURSE INTRODUCTION AND OVERVIEW
  • 8:45AM - 9:45AM

    THE DRUG DEVELOPMENT PROCESS AND REGULATORY ASPECTS
  • 9:45AM - 10:45AM

    PROCEDURES AND GUIDELINES
  • 10:45AM - 11:15AM

    COFFEE BREAK
  • 11:15AM - 12:00PM

    WHAT IS ICH? ICH SAFETY GUIDELINES
  • 12:00PM - 1:00PM

    COMMON TECHNICAL DOCUMENT AND LABELLING
  • 1:00PM - 2:00PM

    LUNCH
  • 2:00PM - 3:00PM

    PHARMACOKINETICS AND METABOLISM (TOXICOKINETICS)
  • 3:00PM - 3:30PM

    COFFEE BREAK
  • 3:30PM - 4:30PM

    SPECIES SELECTION IN DRUG DEVELOPMENT. ALTERNATIVES TO ANIMAL STUDIES - THE 3RS
  • 4:30PM - 5:30PM

    SAFETY PHARMACOLOGY
  • 5:30PM - 5:45PM

    INTEGRATING KINETICS AND METABOLISM CASE STUDIES WITH ROUND TABLE DISCUSSION
  • 5:45PM - 6:45PM

    DRINKS RECEPTION

Day 2 Tuesday, Feb 25, 2014

  • 9:00AM - 10:00AM

    REPEATED DOSE TOXICITY
  • 10:00AM - 11:00AM

    REPRODUCTIVE TOXICITY
  • 11:00AM - 11:30AM

    COFFEE BREAK
  • 11:30AM - 12:30PM

    SPECIAL ORGAN TOXICITY: LIVER
  • 12:30PM - 1:30PM

    LUNCH
  • 1:30PM - 2:30PM

    GENOTOXICITY
  • 2:30PM - 3:00PM

    COFFEE BREAK
  • 3:00PM - 5:00PM

    GROUP ACTIVITY
  • 7:00PM - 10:30PM

    WORKING DINNER

Day 3 Wednesday, Feb 26, 2014

  • 9:00AM - 10:00AM

    NON-CLINICAL DEVELOPMENT OF ANTI-CANCER DRUGS
  • 10:00AM - 11:00AM

    ENVIRONMENTAL RISK ASSESSMENT OF MEDICINAL PRODUCTS FOR HUMAN USE
  • 11:00AM - 11:30AM

    COFFEE BREAK
  • 11:30AM - 12:30PM

    M3 GUIDELINES - PRECLINICAL STUDIES TO SUPPORT FIRST HUMAN CLINICAL TRIALS
  • 12:30PM - 1:30PM

    LUNCH
  • 1:30PM - 2:30PM

    INTRODUCTION TO PRINCIPLES AND FIRST IN HUMAN WITH CASE STUDY
  • 2:30PM - 3:30PM

    INTEGRATING RISK ASSESSMENT WITH CASE STUDY
  • 3:30PM - 4:00PM

    COFFEE BREAK
  • 4:00PM - 5:00PM

    TOXICOLOGICAL QUALIFICATION OF IMPURITIES

Day 4 Thursday, Feb 27, 2014

  • 8:30AM - 9:30AM

    PRECLINICAL CONSIDERATIONS FOR BIOTETCHNOLOGY PRODUCTS
  • 9:30AM - 10:30AM

    PRECLINICAL CONSIDERATIONS FOR BIOSIMILARS
  • 10:30AM - 11:00AM

    COFFEE BREAK
  • 11:00AM - 12:30PM

    ESTIMATION OF FIRST IN HUMAN DOSE: CASE STUDY FOR GROUP ACTIVITY
  • 12:30PM - 2:00PM

    LUNCH
  • 2:00PM - 3:00PM

    PRECLINICAL STUDIES FOR PEDIATRIC INDICATIONS_JUVENILE ANIMAL STUDIES
  • 3:00PM - 3:30PM

    COFFEE BREAK
  • 3:30PM - 5:00PM

    STRATEGIES FOR CARCINOGENICITY TESTING OF HUMAN PHARMACEUTICALS
  • 5:00PM - 6:00PM

    INTEGRATING RISK ASSESSMENT WITH CARCINOGENICITY LIVER TUMOR CASE STUDY

Day 5 Friday, Feb 28, 2014

  • 8:30AM - 9:15AM

    SPECIAL ORGAN TOXICITY – PART TWO: IMMUNE SYSTEM TOXICITY
  • 9:15AM - 10:00AM

    NON-CLINICAL TESTING OF VACCINES AND ADJUVANTS
  • 10:00AM - 10:30AM

    COFFEE BREAK
  • 10:30AM - 1:30PM

    EXAMINATION

Registration Fees 

Other Fees

Member Student
€754.00
NonMember Student
€784.00

Member

Charitable Nonprofit/Academia Member
€1508.00
Member Government
€1508.00
Member Standard
€3016.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€1628.00
NonMember Government
€1628.00
NonMember Standard
€3136.00
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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