Date (Day)       : SEPTEMBER 12TH AND 13TH, 2022 (MONDAY AND TUESDAY)

                        Time                : 9.00 AM – 5.00 PM

                        Venue              : BILIK MERANTI, LEVEL 6, PRIMA 9, CYBERJAYA.

 

ELIGIBILITY

  • Medical device establishments;
  • Medical device industry representatives;
  • Clinical research organization; and also
  • Stakeholders in Malaysia.

 

OBJECTIVES

  • Describe the basic concepts of medical device life cycle.
  • Explain the regulatory pathway for clinical research in Malaysia.
  • Explain the conduct of clinical investigation based on ISO 14155:2020.
  • Describe the elements in preparing Clinical Investigation Plan (CIP) and Investigator’s Brochure (IB).
  • Explain the derivation of clinical evidence for general medical device and IVD medical devices for clinical evaluation.

 

ABOUT THE TRAINING COURSE

  • Introduction on the medical device life cycle.
  • Explanation on the Malaysia regulatory pathway for clinical research.
  • Understanding best practices on conducting clinical investigation according to ISO 14155:2020.
  • In depth understanding on clinical evaluation for general medical device and IVDs.
  • Documentation preparation on submitting a notification of exemption from registration of medical devices for the purpose of device study that includes Clinical Investigation Plan (CIP) and Investigator’s Brochure (IB).
  • Understanding to the important aspects to be covered under clinical investigation plan (CIP) and investigator’s brochure (IB) documentation.

 

 

TENTATIVE PROGRAM

08.45 AM

08.55 AM

09.00 AM

10.30 AM

10.45 AM

12.45 PM

02.00 PM

03.30 PM

03.45 PM

04.15 PM

SEPTEMBER 12TH, 2022 (MONDAY)

 

 

Registration

Briefing

Medical Device Life Cycle, Ms Marianne Yap & Mr Cai Yiting (Alcon Singapore) 

AM Break

Clinical Evaluation for General Medical Device, Ms Marianne Yap & Mr Cai Yiting (Alcon Singapore)      

Lunch Break                                                   

Clinical Evaluation for IVDs Medical Device, Ms Divya Punwani (Roche Singapore)

PM Break

Regulatory Pathway for Clinical Research in Malaysia, Ms. Nashirah Naiimi (MDA)

End of session

 

 

 

 

 


TENTATIVE PROGRAM

 

 

08.45 AM

08.55 AM

09.00 AM

10.30 AM

10.45 AM

12.45 PM

02.00 PM

03.00 PM

03.15 PM

04.15 PM

SEPTEMBER 13TH, 2022 (TUESDAY)

All topics will be presented by Dr Lim Teck Onn

Registration

Briefing

Clinical Investigation: Best Practices according to ISO 14155

AM Break

How to prepare a Clinical Investigation Plan (CIP)

Lunch Break

How to prepare an Investigator’s Brochure (IB)

PM Break

How to prepare an Investigator’s Brochure (IB) (continue)

End of session

 

REGISTRATION & TRAINING FEE

Training fee per participant : RM 2,400.00

Application for the training shall be made via provided Registration Form by

Clicking HERE

 

Should you have any enquiries, please do not hesitate to contact the Training Secretariats:

 (trainingpackage@mda.gov.my) at 03-8230 0395 / 0240 / 0355 / 0211 / 0343

 

 

Updated: 18/82022