Always on the side of safety

A top priority for us at PharmaMar is that our medicines perform as expected and that is why we monitor all of our medicines from the first patient to get it until its last.

How do we ensure drug safety?

How do we ensure drug safety?

How do drugs get to a patient?

From research to commercialization, drugs pass extensive monitoring and the highest tests of safety.

DISCOVERY

TRIALS

APPROVAL

VIGILANCE

We explore the seas to find novel molecules that can treat cancer.

The molecules are isolated and then synthesized.

Aplidin

Thorough testing in cell and animal models help to define

the drug’s potential and use in humans.

Trials in humans are called clinical trials and broken into

Phase I, II and III and will test to define the safety and efficacy.

Marine organism

New medicines are reviewed by relevant regulatory agencies

e.g., FDA, EMA; they decide if they are safe and effective to

allow marketing and for what and to whom.

Yondelis

Even after approved, the drug is monitored for patient safety.

Marine organism

DISCOVERY

We explore the seas to find novel molecules that can treat cancer.

The molecules are isolated and then synthesized.

Aplidin

TRIALS

Thorough testing in cell and animal models help to define

the drug’s potential and use in humans.

Trials in humans are called clinical trials and broken into

Phase I, II and III and will test to define the safety and efficacy.

Marine organism

APPROVAL

New medicines are reviewed by relevant regulatory agencies

e.g., FDA, EMA; they decide if they are safe and effective to

allow marketing and for what and to whom.

Yondelis

VIGILANCE

Even after approved, the drug is monitored for patient safety.

Marine organism

What is pharmacovigilance?

"Pharmacogivilance is a regulatory requirement for all drug manufacturers. It's part of our commitment to patients and healthcare providers that they have the tools to determine the risk-benefit of the drug and use it appropriately."

Hervé Dhellot

Global Pharmacovigilance Head, PharmaMar

What happens when..

somebody experiences an unknown side effect?

Report sent

Side effects are reported by the person taking the medicine or anyone who becomes aware of them.

Report a side effect

Communication to health authorities

Pharmaceutical companies like Pharmamar receive the information and pass it on to the approriate authorities.

Risk-benefit assessment

Healthcare authorities determine if the risk-benefit of the medicine has changed, and if further steps must be taken.

Here is why it matters

Pharmacovigilance is essential to public trust in medicines

Adverse events and side effects

They should be reported promptly by the person taking the medicine or anyone who becomes aware of them to their healthcare provider and to PharmaMar.

Privacy

They are shared anonymously with healthcare authorities who then determine if the risk-benefit of the medicine has changed.

Communicate

Sometimes, it is necessary to amend the label and communicate the adverse event to healthcare professionals and/or patients, occasionally even to remove the drug from the market.

HELP US MAINTAIN THE HIGHEST STANDARDS OF SAFETY

If you are aware of any side effect or adverse event for anyone including you or a loved one using one of our medicines, please report it immediately to us.

Report a side effect ->

Who can communicate an adverse event?

Communicating side effects and adverse events is a shared responsibility, where everyone is a key actor.

Patients

Nurses

Pharmacist

Health Care Providers

Doctors

Caregivers & Family

Scientific Journal

Health Care Agencies

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