Pharmacovigilance training for company employees

1. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT Pharmacovigilance training for company employees Global Pharmacovigilance Department Aurobindo Pharma Ltd, India Version-03 Dated: 07-Mar-2014

2. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT Purpose of training: Consumer, patients and healthcare professionals play an important role in the reporting process of safety related information. To enable Aurobindo to provide up-to-date safety information on Aurobindo products, your support is pivotal to continued patient and drug safety.

3. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT

4. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT • Pharmacovigilance (WHO) Definition: “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any possible problems related to drugs, biologicals, medical devices, blood products, vaccines, as well as, herbal, traditional and complementary medicines.”

5. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT • Adverse Events (AEs): Any untoward medical occurrence in a patient or a clinical-trial subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment.” Not necessarily a causal relationship between medicinal product and AE. Untoward medical occurrences might include: • Disease • Injury • Changes in symptoms • Changes in laboratory test results • Congenital abnormality

6. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT Adverse drug reactions (ADR): A response to a medicinal product which is noxious and unintended. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorization or from occupational exposure. Conditions of use outside the marketing authorization include off-label use, overdose, misuse, abuse and medication errors.

7. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT What information should be reported ? 1. Any information regarding the adverse drug reaction occurring during the course of the use of the drug. 2. Pregnancy cases – where the mother or father have had exposure to the drug that could have been passed on to the child. The pregnancy or a healthy birth are not AEs, but important to collect information and follow up for outcome.

8. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT What information should be reported ? 3. Use of a medicinal product in a pediatric or elderly population. 4. Overdose/Poisoning 5. Misuse and Abuse/ Dependence 6. Lack of effect 7. Suspected transmission of infectious agent 8. Occupational exposure

9. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT • What information should be reported ? • 9. Any information even if no ADRs are observed in the following scenarios: • from drug overdose whether accidental or intentional • From drug abuse / misuse / non-approved use • from drug administration during pregnancy. • lack of effect • off label use • occupational exposure

10. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT I am not working in the Pharmacovigilance department, so why am I receiving this training??

11. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT AUROBINDO has a legal obligation to report ALL Adverse Drug Reactions from the moment they obtain a license. Anyone may receive an Adverse Event (AE) report or other safety information relating to the company’s products. While it is accepted that customer-facing personnel are most likely to receive such reports (such as medical representatives, clinical research, medical information, customer services and product quality), sources of AE reports can extend to friends and family, the lay press and other media, and so these reports could potentially be received by any employee. All personnel should, therefore, receive basic pharmacovigilance training on the receipt and subsequent transfer of safety information to the pharmacovigilance department.

12. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT • What are an employee’s obligations? Once it appears that there may be an adverse event try to get the following information: • Name and contact details of the reporter (preferably telephone number and or e-mail address) • The suspect Aurobindo drug (note batch number and expiry date if possible) • The event/reaction • Patient details (name/initials, age/age group) These four components make a valid report As much information as possible!

13. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT If I receive an ADR report, where should I send it?

14. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT Report the collected information IMMEDIATELY via fax, e-mail or phone to: • Your respective country manager or Responsible person for pharmacovigilance • OR • To QA head of your manufacturing location • OR • Global pharmacovigilance department (GPVD), India

15. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT Contact details of Global Pharmacovigilance Department, India • E-mail: pharmacovigilance@aurobindo.com • Fax: +91-40-23044875 • Phone: +91-40-23044875

16. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT • Why so urgent? • AE reports MUST be sent to the regulatory authorities. The clock for sending AEs starts from day “0”. We must report to authorities within 15 days!! • Day “0” : This is when anyone in the company first receives valid information. • Not sure you have an AE, then simply pass the info on anyway!

17. AUROBINDO PHARMA LTD GLOBAL PHARMACOVIGILANCE DEPARTMENT