Bioavailability / Bioequivalence (BA/BE) Studies – Assessment and Evaluation


2-Day In-Person Seminar (Code – INDSEM135)

Bioavailability / Bioequivalence (BA/BE) Studies – Assessment and Evaluation


    Mumbai, MH, India

 

    December 2 – 3, 2019

Seminar DescriptionAgendaPricingVenue
Bioavailability / Bioequivalence (BA/BE) Studies – Assessment and Evaluation training workshop is organized by Compliance Trainings in collaborations with Ethixinn Consulting and Research. Workshop will last 2 days and is designed for participants:

  • to enhance the knowledge of participants about Bioequivalence studies for better assessment of Generic Medicines.
  • to update them about the current scientific and international regulatory practices for conduct of Bioequivalence (BE) trials.

The workshop will include both classroom and hands on elements to achieve good understanding of current international regulatory requirements on BE testing and qualified interpretation of these requirements during inspections.

Who Should Attend:

  • Clinical Drug Development Departments
  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Project Management Professionals
  • Bio-analytics
  • Biostatisticians
  • Pharmaceutical Scientists
  • Pharmacologists
  • Clinical Scientists
  • Toxicologists

DAY 1 : (8.30 AM – 5 PM)

Registration: 8.30 AM – 9 AM

Session 1:

  • Basic principles, current understanding and best practices for Bioequivalence testing (BA/BE Study)
  • Case Study-1: Investigations for failures and suggestions for a better study design at exploratory study stage

Session 2:

  • Basic principles, current understanding and best practices for Clinical Phase of a BE study and its conduct in line with GCP
  • Basic principles, current understanding and best practices for Bioanalytical Phase – Bioanalytical Method Development and Validation

Session 3:

  • Group Exercise -1: GCP in BA/BE Studies
  • Basic principles, current understanding and best practices for Bioanalytical Phase of a BE study – Investigations, Corrective and preventive actions. (Covering relevant GLP aspects as well)

Session 4:

  • Case Study-2: Post analysis investigations & CAPA

Q&A and Networking: 4.30 PM – 5 PM

DAY 2 : (8.30 AM – 5.30 PM)

 
Session 1:

  • Regulatory Requirements – BE Studies
  • Quality Practices for BA/BE Centres / CRO (GLP/GCLP/GMP)

Session 2:

  • Practical aspects and preparations for clinical and bioanalytical Laboratory
  • Basic principles, current understanding and best practices for PK and Statistical Phase of a BE study

Session 3:

  • Data integrity in BE trials and common inspection observations

Session 4:

  • Group Exercise: Preparing for a GCP/GLP Inspection – CRO
  • Group-1: Prepared as Auditee
  • Group-2: Prepared as Auditor
  • Communication to CRO, Preparing & sharing Inspection Agenda and defining Team’s roles for proposed CRO Inspection

Q&A, Certification, Networking and Close: 5 PM – 5.30 PM

PRICING OPTIONS & REGISTRATION

Seats and Accommodation are limited and based on first-come, first-serve

 

Mumbai, MH, India

December 2 – 3, 2019
Venue to be announced soon

Call for Assistance: +91-80-4170-0521   Register Now